Chest PainECLECTICNCT07192965
ECG-less Coronary Computed Tomography Angiography in the Management of Patients Presenting With High-troponin Chest Pain
A study testing Non-ECG-gated computed tomography in people with Chest Pain and Acute Coronary Syndromes (ACS), run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Chest pain represents a common reason for consultation to emergency room. This symptom can be explained by a broad spectrum of conditions, from benign musculoskeletal or esophageal pain to life-threatening disease such as aortic dissection, pulmonary embolism, and myocardial infarction. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Chest Pain, Acute Coronary Syndromes (ACS)
- What is being tested?
- Non-ECG-gated computed tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Sep 2025to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 30 years old
- Admission at the ER with acute chest pain and at least one of the follow-ing:
- ECG abnormality;
- positive rule-in criteria according to the ESC guidelines (hs-cTnT ≥ 52 in at least one assay or 1h ∆ ≥ 5);
- troponine value in the "observe pathway" (hs-cTnT ≥ 12 in at least one assay or 1h ∆ ≥ 3) AND a high clinical suspicion of MI.
Who cannot join
- Indication for urgent ICA (ST-elevation, hemodynamic or electric instabil-ity, refractory chest pain, mechanical complications)
- eGFR < 30 ml/min
- Previous coronary stenting
- Previous CABG
- Recent ACS within 6 months
- Known severely reduced ejection fraction (EF < 30%)
Show all 12Show fewer
- Contrast allergy
- Inability to provide informed consent
- Limited life expectancy < 2 years due to non-cardiac conditions
- Pregnant and breast-feeding women
- Known congenital heart disease
- Atrial fibrillation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jean François Argacha, Professor contact
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Jette, 1090
Evelyne Wirix, 0032 498541671, Evelyne.Wirix@uzbrussel.be
Jean Francois Argacha, Professor
About this study
Chest pain represents a common reason for consultation to emergency room. This symptom can be explained by a broad spectrum of conditions, from benign musculoskeletal or esophageal pain to life-threatening disease such as aortic dissection, pulmonary embolism, and myocardial infarction.
There are already different diagnostic tools to quickly identify most dangerous diseases, for example electrocardiogram, blood samples with specific markers of cardiac injury, chest X-ray and echography. In case a doubt of disease is raised after the first clinical evaluation, it is possible to proceed with more complex, expensive and invasive examinations, namely a computed tomography (CT) scan or an invasive coronary angiography (ICA).
Read more
CT scan allows the diagnosis of various conditions such as pleural, pulmonary, pericardial and vascular disease such as pneumonia, pneumothorax, pleural and pericardial fluid, pulmonary embolism (PE), acute aortic dissection (AOD). In order to see the pulmonary, aortic and coronary arteries, a contrast injection is needed. Moreover, since the heart and the aortic root are continuously moving, specific technical measures to obtain good quality images are needed.
Recently, a new CT scan system has been developed. It allows to obtain good quality images of the heart and aortic root using an estimated heart rhythm, without ECG-gating. This allows to perform a CT scan of the heart in a reduced amount of time, and without need for controlling heart rate. Moreover, it is possible to obtain information on both aortic, coronary, and pulmonary artery with the same contrast injection. This may be of great interest in the context of patients presenting at the emergency room with chest pain and with a suspicion of pulmonary embolism, myocardial infarction, or aortic dissection, since with a single fast exam it is possible to rule out all these conditions.
Coronary arteries are very small vessels, and the accuracy of this new technique in identifying a significant obstruction is still to be proved. At present, patients with chest pain and a suspicion of myocardial infarction undergo an invasive coronary angiography. If this new tool proves to be reliable, it will be possible to reduce the number of useless invasive examination in patients in which the presence of coronary artery disease (CAD) is ruled-out. In addition, the CT scan can help quickly and effectively plan treatment when worrying abnormalities are detected in the coronary arteries that are associated with a higher risk.
Therefore, this clinical trial (further on referred to as "trial") will evaluate the investigational medicinal product (IMP), ECG-less Revolution Apex Elite system (GE Healthcare, Waukesha, WI -USA) for the diagnosis of coronary artery disease. The purpose of this trial is to learn about: the accuracy of this new CT system compared to the gold standard invasive coronary angiography in diagnosing coronary artery disease. The number of patients receiving an alternative diagnosis such as pulmonary embolism, aortic dissection, pulmonary, pleural or pericardial disease will be evaluated. Finally, the prognostic predictive value of the CT compared with ICA, in predicting myocardial infarction, coronary revascularization, and cardiac death at a follow-up of 18 months will be assessed. Patient will undergo a computer tomography examination with this new technique, evaluating both pulmonary, aortic, and coronary arteries. Then, as indicated by current guidelines, they will undergo an invasive coronary angiography.
Read the detailed description
- Study Rationale The aim is to investigate the potential role of CCTA in patients presenting to the emergency room with thoracic pain and elevated troponins. Using a single contrast bolus and a lower radiation dose, the new ECG-less CCTA could help exclude life-threatening conditions such as PE and AAD, while providing valuable information about the coronary arteries. Patients with normal coronary arteries could be safely discharged without invasive examinations, thus avoiding pro-cedural risks and optimizing both time and resources for medical institutions. However, since the diagnostic role of ECG-less CCTA in ACS has not yet been demonstrated, current guidelines and best practices will be followed in the management of enrolled patients. Decisions regard-ing PCI will be based on coronary angiography, coronary physiology, and intravascular imaging, as currently recommended by international guidelines. The negative and positive predictive value of the ECG-less CCTA compared to the standard of care (ICA) in patients clinically considered at risk for NSTEMI will be assessed. Additionally, the prognostic predictive value of CCTA in this clinical context, in compari-son to ICA will be evaluated. If the prognostic value of CCTA is similar to that of ICA, it will be possible to reduce the use of invasive procedures in favor of non-invasive exams, thereby saving time, contrast, and radia-tion dose for the patient.
- Primary Objectives
- Evaluate the diagnostic accuracy of the non-ECG-gated CCTA in diagnosing CAD compared to the gold standard (ICA) in terms of negative and positive predictive value, sensitivity, and specificity.
- Assess the accuracy in excluding high-risk CAD such as LM, proximal LAD and multivessel disease.
- Describe the proportion of patients diagnosed as NSTE-ACS according to the ESC guidelines who will receive an alternative diagnosis thanks to the CCTA, in particular PE and AAD.
- Secondary Objectives
- Assess the capacity of the non-ECG-gated CCTA in predicting the mid and long-term out-come compared to the ICA.
- Investigate the possibility of applying the tool of FFR-CT calculation at images obtained by means of non-ECG-gated CCTA.
- Study Design Prospective, single-center, double-blinded study.
- Study Population Patients presenting at the ER with acute chest pain and either a diagnosis of NSTEMI at "high-risk" according to the 2023 ESC guidelines on ACS or a troponin value in the "observe pathway" and a high clinical suspicion of MI.
- Study protocol Patients presenting with acute chest pain and elevated troponin either in the "rule-in" or "ob-serve pathway" according to ESC guidelines on ACS will be offered to participate to this study evaluating the role of non-ECG-gated CTA in patients with NSTEMI. After giving the consent, patients will be sent for non-ECG-gated CTA for the evaluation of coronary arteries, ascendent aorta and pulmonary arteries. After the CT and within 24 hours, patients will undergo ICA. Both the patient and the interventional cardiologist will be blinded to the result of the CT, the only exception being the diagnosis of a disease other than CAD which is considered responsible for the clinical presentation. The analysis of the CT images will be repeated in a core lab by the consensus of two radiologist with a wide experience in CCTA. Readers will be blinded to clini-cal data and ICA results.
ECG-less CT Patients will undergo scanning with a Revolution Apex Elite system (GE Healthcare, WI, USA), using hyperdrive pulmonary CT angiography (523mm/s with 0.28s/rotation gantry speed). Images will be acquired using the ECG-less Cardiac software (GE Healthcare, WI, USA), without the need for patient-attached ECG leads. The system uses a wide detector coverage of 160mm to provide full heart coverage and a fast gantry speed of 0.23 seconds per rotation to perform imaging in a single cardiac cycle. An estimation of the heart rhythm must be provided, which is always available since emergency patients are already monitored with finger pulse oximeter. Based on the heart rhythm the scanner simulates an ECG signal. This simulated ECG signal provides virtual gating of the scan. Acquisition can be performed over one full heart cycle, three-quarters, or half cycle, depending on heart rate. Advanced software tools including SmartPhase (automated phase selection) and SnapShot Freeze 2 (optimized volume registration) will be used to enhance image quality and correct for motion. After a short delay of 5-12 sec, allowing contrast to pass from the pulmonary circulation into the aorta and coronary arteries, a coronary CT angiography will be performed using the same contrast bolus. No additional contrast will be administered for cardiac imaging. No intravenous β-blocker or sublingual nitroglycerin will be administered. The total added exam time (including heart rhythm assessment, scan preparation, delay, and the acquisition itself) is estimated at 1-2 minutes.
Invasive coronary angiography and revascularization Patients will undergo an ICA following local and international best practices. The UZ Brussel in-terventional department is a high-volume center with experience in complex percutaneous coronary interventions (PCI). The procedures will be performed with trans-radial access when feasible. Any attention will be paid to reduce the total amount of contrast.
In case of moderate stenosis, the operator will use the invasive FFR to indicate PCI. The use of intravascular imaging is encouraged.
In case of significant CAD, patients will be treated with PCI following the ESC guidelines. The choice of interventional technique and DAPT regimen is left to the operator and the treating cardiologist.
Complete revascularization will be pursued either during the same hospitalization or within one month.
- Conditions
- Chest Pain, Acute Coronary Syndromes (ACS)
- Being tested
- Non-ECG-gated computed tomography
- Keywords
- Chest pain, Acute coronary syndrome, NSTEMI, ECG-less coronary computed tomography angiography, ECG-les CCTA
- Medical subject headings
- Chest Pain, Acute Coronary Syndrome, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-ECG-gated computed tomographyRadiation
Scanning with a Revolution Apex Elite system (GE Healthcare, WI, USA), using hyperdrive pulmonary CT angiography (523mm/s with 0.28s/rotation gantry speed). Images will be acquired using the ECG-less Cardiac software (GE Healthcare, WI, USA), without the need for patient-attached ECG leads. The system uses a wide detector coverage of 160mm to provide full heart coverage and a fast gantry speed of 0.23 seconds per rotation to perform imaging in a single cardiac cycle. An estimation of the heart rhythm must be provided, based on the heart rhythm the scanner simulates an ECG signal. This simulated ECG signal provides virtual gating of the scan. Advanced software tools including SmartPhase (automated phase selection) and SnapShot Freeze 2 (optimized volume registration) will be used. After a short delay of 5-12 sec, allowing contrast to pass from the pulmonary circulation into the aorta and coronary arteries, a coronary CT angiography will be performed using the same contrast bolus.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | All patients will be before scanned with a ECG-less CCTA and then undergo invasive coronary angiography. There is one single arm. Receives: Radiation: Non-ECG-gated computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of ECG-less CCTA for detecting obstructive coronary artery disease (defined as luminal narrowing ≥ 50%), compared to invasive coronary angiography
In both studies, sensitivity, specificity, positive and negative predictive value will be calculated. Diagnostic accuracy will be assessed using the McNemar test to compare CCTA with ICA. Cohen's Kappa agreement test will be used to evaluate agreement in diagnostic categorization between the two modalities.
Measured: Up to 12 weeks
Secondary outcomes (1)
Accuracy of CCTA in detecting high-risk CAD such as LM, proximal LAD and multivessel disease compared to invasive coronary angigoraphy
Accuracy of CCTA in detecting high-risk CAD such as LM, proximal LAD and multivessel disease compared to invasive coronary angigoraphy
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start10 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Giangiacomi, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192965
- Sponsor's protocol ID
- 1432025000119
- Acronym
- ECLECTIC
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Kofoed KF, Engstrom T, Sigvardsen PE, Linde JJ, Torp-Pedersen C, de Knegt M, Hansen PR, Fritz-Hansen T, Bech J, Heitmann M, Nielsen OW, Hofsten D, Kuhl JT, Raymond IE, Kristiansen OP, Svendsen IH, Dominguez Vall-Lamora MH, Kragelund C, Hove JD, Jorgensen T, Fornitz GG, Steffensen R, Jurlander B, Abdulla J, Lyngbaek S, Elming H, Therkelsen SK, Jorgensen E, Klovgaard L, Bang LE, Helqvist S, Galatius S, Pedersen F, Abildgaard U, Clemmensen P, Saunamaki K, Holmvang L, Gislason G, Kelbaek H, Kober LV. Prognostic Value of Coronary CT Angiography in Patients With Non-ST-Segment Elevation Acute Coronary Syndromes. J Am Coll Cardiol. 2021 Mar 2;77(8):1044-1052. doi: 10.1016/j.jacc.2020.12.037.
PubMed 33632478Linde JJ, Hove JD, Sorgaard M, Kelbaek H, Jensen GB, Kuhl JT, Hindso L, Kober L, Nielsen WB, Kofoed KF. Long-Term Clinical Impact of Coronary CT Angiography in Patients With Recent Acute-Onset Chest Pain: The Randomized Controlled CATCH Trial. JACC Cardiovasc Imaging. 2015 Dec;8(12):1404-1413. doi: 10.1016/j.jcmg.2015.07.015. Epub 2015 Nov 11.
PubMed 26577263Litt HI, Gatsonis C, Snyder B, Singh H, Miller CD, Entrikin DW, Leaming JM, Gavin LJ, Pacella CB, Hollander JE. CT angiography for safe discharge of patients with possible acute coronary syndromes. N Engl J Med. 2012 Apr 12;366(15):1393-403. doi: 10.1056/NEJMoa1201163. Epub 2012 Mar 26.
PubMed 22449295Hoffmann U, Truong QA, Schoenfeld DA, Chou ET, Woodard PK, Nagurney JT, Pope JH, Hauser TH, White CS, Weiner SG, Kalanjian S, Mullins ME, Mikati I, Peacock WF, Zakroysky P, Hayden D, Goehler A, Lee H, Gazelle GS, Wiviott SD, Fleg JL, Udelson JE; ROMICAT-II Investigators. Coronary CT angiography versus standard evaluation in acute chest pain. N Engl J Med. 2012 Jul 26;367(4):299-308. doi: 10.1056/NEJMoa1201161.
PubMed 22830462Wang K, Zhang Y, Chen B, Ren H. Comparing image quality of coronary CT angiography with and without ECG-gating in wide-detector CT. Front Cardiovasc Med. 2025 Apr 11;12:1570743. doi: 10.3389/fcvm.2025.1570743. eCollection 2025.
PubMed 40290191Linde JJ, Kelbaek H, Hansen TF, Sigvardsen PE, Torp-Pedersen C, Bech J, Heitmann M, Nielsen OW, Hofsten D, Kuhl JT, Raymond IE, Kristiansen OP, Svendsen IH, Vall-Lamora MHD, Kragelund C, de Knegt M, Hove JD, Jorgensen T, Fornitz GG, Steffensen R, Jurlander B, Abdulla J, Lyngbaek S, Elming H, Therkelsen SK, Jorgensen E, Klovgaard L, Bang LE, Hansen PR, Helqvist S, Galatius S, Pedersen F, Abildgaard U, Clemmensen P, Saunamaki K, Holmvang L, Engstrom T, Gislason G, Kober LV, Kofoed KF. Coronary CT Angiography in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome. J Am Coll Cardiol. 2020 Feb 11;75(5):453-463. doi: 10.1016/j.jacc.2019.12.012.
PubMed 32029126Meier D, Andreini D, Cosyns B, Skalidis I, Storozhenko T, Mahendiran T, Assanelli E, Sonck J, Roosens B, Rotzinger DC, Qanadli SD, Tzimas G, Muller O, De Bruyne B, Collet C, Fournier S. Usefulness of FFR-CT to exclude haemodynamically significant lesions in high-risk NSTE-ACS. EuroIntervention. 2025 Jan 6;21(1):73-81. doi: 10.4244/EIJ-D-24-00779.
PubMed 39468963Gray AJ, Roobottom C, Smith JE, Goodacre S, Oatey K, O'Brien R, Storey RF, Curzen N, Keating L, Kardos A, Felmeden D, Lee RJ, Thokala P, Lewis SC, Newby DE; RAPID-CTCA Investigators. Early computed tomography coronary angiography in patients with suspected acute coronary syndrome: randomised controlled trial. BMJ. 2021 Sep 29;374:n2106. doi: 10.1136/bmj.n2106.
PubMed 34588162Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.
PubMed 37622654Thomsen B, Nabipoor A, Asadian S, Reiser I, Cotella J, Okerlund D, Challman M, Landeras L, Chalian H. Coronary computed tomography angiography without ECG leads; A feasibility study. Curr Probl Diagn Radiol. 2026 May-Jun;55(3):426-431. doi: 10.1067/j.cpradiol.2025.04.019. Epub 2025 Apr 29.
PubMed 40328582Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.
PubMed 39210710SCOT-HEART Investigators; Newby DE, Adamson PD, Berry C, Boon NA, Dweck MR, Flather M, Forbes J, Hunter A, Lewis S, MacLean S, Mills NL, Norrie J, Roditi G, Shah ASV, Timmis AD, van Beek EJR, Williams MC. Coronary CT Angiography and 5-Year Risk of Myocardial Infarction. N Engl J Med. 2018 Sep 6;379(10):924-933. doi: 10.1056/NEJMoa1805971. Epub 2018 Aug 25.
PubMed 30145934Mancini GBJ, Leipsic J, Budoff MJ, Hague CJ, Min JK, Stevens SR, Reynolds HR, O'Brien SM, Shaw LJ, Manjunath CN, Mavromatis K, Demkow M, Lopez-Sendon JL, Chernavskiy AM, Gosselin G, Schuchlenz H, Devlin GP, Chauhan A, Bangalore S, Hochman JS, Maron DJ. CT Angiography Followed by Invasive Angiography in Patients With Moderate or Severe Ischemia-Insights From the ISCHEMIA Trial. JACC Cardiovasc Imaging. 2021 Jul;14(7):1384-1393. doi: 10.1016/j.jcmg.2020.11.012. Epub 2021 Jan 13.
PubMed 33454249Andreini D, Pontone G, Mushtaq S, Bartorelli AL, Bertella E, Antonioli L, Formenti A, Cortinovis S, Veglia F, Annoni A, Agostoni P, Montorsi P, Ballerini G, Fiorentini C, Pepi M. A long-term prognostic value of coronary CT angiography in suspected coronary artery disease. JACC Cardiovasc Imaging. 2012 Jul;5(7):690-701. doi: 10.1016/j.jcmg.2012.03.009.
PubMed 22789937Giangiacomi F, Popelier B, Lochy S, Nieboer K, Von Kemp M, Belsack D, Tanaka K, Cosyns B, Argacha JF, De Mey J. OPENing a new ECLECTIC approach to NSTEMI and cardiac arrest using ECG-less coronary computed tomography angiography. Study design and rationale of two prospective clinical studies. Cardiovasc Revasc Med. 2026 Jan;82:36-41. doi: 10.1016/j.carrev.2025.11.009. Epub 2025 Nov 21.
PubMed 41314866
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECG-less Coronary Computed Tomography Angiography in the Management of Patients Presenting With High-troponin Chest Pain
- ClinicalTrials.gov ID
- NCT07192965
- Acronym / sponsor ID
- ECLECTIC / 1432025000119
- Conditions
- Chest Pain, Acute Coronary Syndromes (ACS)
- Keywords
- Chest pain, Acute coronary syndrome, NSTEMI, ECG-less coronary computed tomography angiography, ECG-les CCTA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chest pain represents a common reason for consultation to emergency room. This symptom can be explained by a broad spectrum of conditions, from benign musculoskeletal or esophageal pain to life-threatening disease such as aortic dissection, pulmonary embolism, and myocardial infarction.
There are already different diagnostic tools to quickly identify most dangerous diseases, for example electrocardiogram, blood samples with specific markers of cardiac injury, chest X-ray and echography. In case a doubt of disease is raised after the first clinical evaluation, it is possible to proceed with more complex, expensive and invasive examinations, namely a computed tomography (CT) scan or an invasive coronary angiography (ICA).
CT scan allows the diagnosis of various conditions such as pleural, pulmonary, pericardial and vascular disease such as pneumonia, pneumothorax, pleural and pericardial fluid, pulmonary embolism (PE), acute aortic dissection (AOD). In order to see the pulmonary, aortic and coronary arteries, a contrast injection is needed. Moreover, since the heart and the aortic root are continuously moving, specific technical measures to obtain good quality images are needed.
Recently, a new CT scan system has been developed. It allows to obtain good quality images of the heart and aortic root using an estimated heart rhythm, without ECG-gating. This allows to perform a CT scan of the heart in a reduced amount of time, and without need for controlling heart rate. Moreover, it is possible to obtain information on both aortic, coronary, and pulmonary artery with the same contrast injection. This may be of great interest in the context of patients presenting at the emergency room with chest pain and with a suspicion of pulmonary embolism, myocardial infarction, or aortic dissection, since with a single fast exam it is possible to rule out all these conditions.
Coronary arteries are very small vessels, and the accuracy of this new technique in identifying a significant obstruction is still to be proved. At present, patients with chest pain and a suspicion of myocardial infarction undergo an invasive coronary angiography. If this new tool proves to be reliable, it will be possible to reduce the number of useless invasive examination in patients in which the presence of coronary artery disease (CAD) is ruled-out. In addition, the CT scan can help quickly and effectively plan treatment when worrying abnormalities are detected in the coronary arteries that are associated with a higher risk.
Therefore, this clinical trial (further on referred to as "trial") will evaluate the investigational medicinal product (IMP), ECG-less Revolution Apex Elite system (GE Healthcare, Waukesha, WI -USA) for the diagnosis of coronary artery disease. The purpose of this trial is to learn about: the accuracy of this new CT system compared to the gold standard invasive coronary angiography in diagnosing coronary artery disease. The number of patients receiving an alternative diagnosis such as pulmonary embolism, aortic dissection, pulmonary, pleural or pericardial disease will be evaluated. Finally, the prognostic predictive value of the CT compared with ICA, in predicting myocardial infarction, coronary revascularization, and cardiac death at a follow-up of 18 months will be assessed. Patient will undergo a computer tomography examination with this new technique, evaluating both pulmonary, aortic, and coronary arteries. Then, as indicated by current guidelines, they will undergo an invasive coronary angiography.
Detailed description
- Study Rationale The aim is to investigate the potential role of CCTA in patients presenting to the emergency room with thoracic pain and elevated troponins. Using a single contrast bolus and a lower radiation dose, the new ECG-less CCTA could help exclude life-threatening conditions such as PE and AAD, while providing valuable information about the coronary arteries. Patients with normal coronary arteries could be safely discharged without invasive examinations, thus avoiding pro-cedural risks and optimizing both time and resources for medical institutions. However, since the diagnostic role of ECG-less CCTA in ACS has not yet been demonstrated, current guidelines and best practices will be followed in the management of enrolled patients. Decisions regard-ing PCI will be based on coronary angiography, coronary physiology, and intravascular imaging, as currently recommended by international guidelines. The negative and positive predictive value of the ECG-less CCTA compared to the standard of care (ICA) in patients clinically considered at risk for NSTEMI will be assessed. Additionally, the prognostic predictive value of CCTA in this clinical context, in compari-son to ICA will be evaluated. If the prognostic value of CCTA is similar to that of ICA, it will be possible to reduce the use of invasive procedures in favor of non-invasive exams, thereby saving time, contrast, and radia-tion dose for the patient.
- Primary Objectives
- Evaluate the diagnostic accuracy of the non-ECG-gated CCTA in diagnosing CAD compared to the gold standard (ICA) in terms of negative and positive predictive value, sensitivity, and specificity.
- Assess the accuracy in excluding high-risk CAD such as LM, proximal LAD and multivessel disease.
- Describe the proportion of patients diagnosed as NSTE-ACS according to the ESC guidelines who will receive an alternative diagnosis thanks to the CCTA, in particular PE and AAD.
- Secondary Objectives
- Assess the capacity of the non-ECG-gated CCTA in predicting the mid and long-term out-come compared to the ICA.
- Investigate the possibility of applying the tool of FFR-CT calculation at images obtained by means of non-ECG-gated CCTA.
- Study Design Prospective, single-center, double-blinded study.
- Study Population Patients presenting at the ER with acute chest pain and either a diagnosis of NSTEMI at "high-risk" according to the 2023 ESC guidelines on ACS or a troponin value in the "observe pathway" and a high clinical suspicion of MI.
- Study protocol Patients presenting with acute chest pain and elevated troponin either in the "rule-in" or "ob-serve pathway" according to ESC guidelines on ACS will be offered to participate to this study evaluating the role of non-ECG-gated CTA in patients with NSTEMI. After giving the consent, patients will be sent for non-ECG-gated CTA for the evaluation of coronary arteries, ascendent aorta and pulmonary arteries. After the CT and within 24 hours, patients will undergo ICA. Both the patient and the interventional cardiologist will be blinded to the result of the CT, the only exception being the diagnosis of a disease other than CAD which is considered responsible for the clinical presentation. The analysis of the CT images will be repeated in a core lab by the consensus of two radiologist with a wide experience in CCTA. Readers will be blinded to clini-cal data and ICA results.
ECG-less CT Patients will undergo scanning with a Revolution Apex Elite system (GE Healthcare, WI, USA), using hyperdrive pulmonary CT angiography (523mm/s with 0.28s/rotation gantry speed). Images will be acquired using the ECG-less Cardiac software (GE Healthcare, WI, USA), without the need for patient-attached ECG leads. The system uses a wide detector coverage of 160mm to provide full heart coverage and a fast gantry speed of 0.23 seconds per rotation to perform imaging in a single cardiac cycle. An estimation of the heart rhythm must be provided, which is always available since emergency patients are already monitored with finger pulse oximeter. Based on the heart rhythm the scanner simulates an ECG signal. This simulated ECG signal provides virtual gating of the scan. Acquisition can be performed over one full heart cycle, three-quarters, or half cycle, depending on heart rate. Advanced software tools including SmartPhase (automated phase selection) and SnapShot Freeze 2 (optimized volume registration) will be used to enhance image quality and correct for motion. After a short delay of 5-12 sec, allowing contrast to pass from the pulmonary circulation into the aorta and coronary arteries, a coronary CT angiography will be performed using the same contrast bolus. No additional contrast will be administered for cardiac imaging. No intravenous β-blocker or sublingual nitroglycerin will be administered. The total added exam time (including heart rhythm assessment, scan preparation, delay, and the acquisition itself) is estimated at 1-2 minutes.
Invasive coronary angiography and revascularization Patients will undergo an ICA following local and international best practices. The UZ Brussel in-terventional department is a high-volume center with experience in complex percutaneous coronary interventions (PCI). The procedures will be performed with trans-radial access when feasible. Any attention will be paid to reduce the total amount of contrast.
In case of moderate stenosis, the operator will use the invasive FFR to indicate PCI. The use of intravascular imaging is encouraged.
In case of significant CAD, patients will be treated with PCI following the ESC guidelines. The choice of interventional technique and DAPT regimen is left to the operator and the treating cardiologist.
Complete revascularization will be pursued either during the same hospitalization or within one month.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Radiation: Non-ECG-gated computed tomographyAll patients will be before scanned with a ECG-less CCTA and then undergo invasive coronary angiography. There is one single arm. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 30 years old
- Admission at the ER with acute chest pain and at least one of the follow-ing:
Key exclusion criteria (12 listed)
- Indication for urgent ICA (ST-elevation, hemodynamic or electric instabil-ity, refractory chest pain, mechanical complications)
- eGFR < 30 ml/min
- Previous coronary stenting
- Previous CABG
- Recent ACS within 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-ECG-gated computed tomographyScanning with a Revolution Apex Elite system (GE Healthcare, WI, USA), using hyperdrive pulmonary CT angiography (523mm/s with 0.28s/rotation gantry speed). Images will be acquired using the ECG-less Cardiac software (GE Healthcare, WI, USA), without the need for patient-attached ECG leads. The system uses a wide detector coverage of 160mm to provide full heart coverage and a fast gantry speed of 0.23 seconds per rotation to perform imaging in a single cardiac cycle. An estimation of the heart rhythm must be provided, based on the heart rhythm the scanner simulates an ECG signal. This simulated ECG signal provides virtual gating of the scan. Advanced software tools including SmartPhase (automated phase selection) and SnapShot Freeze 2 (optimized volume registration) will be used. After a short delay of 5-12 sec, allowing contrast to pass from the pulmonary circulation into the aorta and coronary arteries, a coronary CT angiography will be performed using the same contrast bolus. | Radiation | Single arm |
Primary outcome
Diagnostic accuracy of ECG-less CCTA for detecting obstructive coronary artery disease (defined as luminal narrowing ≥ 50%), compared to invasive coronary angiography
Time frame: Up to 12 weeks
In both studies, sensitivity, specificity, positive and negative predictive value will be calculated. Diagnostic accuracy will be assessed using the McNemar test to compare CCTA with ICA. Cohen's Kappa agreement test will be used to evaluate agreement in diagnostic categorization between the two modalities.
1 secondary outcome
Accuracy of CCTA in detecting high-risk CAD such as LM, proximal LAD and multivessel disease compared to invasive coronary angigoraphy
Time frame: Up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Background: PubMed 33632478Kofoed KF, Engstrom T, Sigvardsen PE, Linde JJ, Torp-Pedersen C, de Knegt M, Hansen PR, Fritz-Hansen T, Bech J, Heitmann M, Nielsen OW, Hofsten D, Kuhl JT, Raymond IE, Kristiansen OP, Svendsen IH, Dominguez Vall-Lamora MH, Kragelund C, Hove JD, Jorgensen T, Fornitz GG, Steffensen R, Jurlander B, Abdulla J, Lyngbaek S, Elming H, Therkelsen SK, Jorgensen E, Klovgaard L, Bang LE, Helqvist S, Galatius S, Pedersen F, Abildgaard U, Clemmensen P, Saunamaki K, Holmvang L, Gislason G, Kelbaek H, Kober LV. Prognostic Value of Coronary CT Angiography in Patients With Non-ST-Segment Elevation Acute Coronary Syndromes. J Am Coll Cardiol. 2021 Mar 2;77(8):1044-1052. doi: 10.1016/j.jacc.2020.12.037.
- Background: PubMed 26577263Linde JJ, Hove JD, Sorgaard M, Kelbaek H, Jensen GB, Kuhl JT, Hindso L, Kober L, Nielsen WB, Kofoed KF. Long-Term Clinical Impact of Coronary CT Angiography in Patients With Recent Acute-Onset Chest Pain: The Randomized Controlled CATCH Trial. JACC Cardiovasc Imaging. 2015 Dec;8(12):1404-1413. doi: 10.1016/j.jcmg.2015.07.015. Epub 2015 Nov 11.
- Background: PubMed 22449295Litt HI, Gatsonis C, Snyder B, Singh H, Miller CD, Entrikin DW, Leaming JM, Gavin LJ, Pacella CB, Hollander JE. CT angiography for safe discharge of patients with possible acute coronary syndromes. N Engl J Med. 2012 Apr 12;366(15):1393-403. doi: 10.1056/NEJMoa1201163. Epub 2012 Mar 26.
- Background: PubMed 22830462Hoffmann U, Truong QA, Schoenfeld DA, Chou ET, Woodard PK, Nagurney JT, Pope JH, Hauser TH, White CS, Weiner SG, Kalanjian S, Mullins ME, Mikati I, Peacock WF, Zakroysky P, Hayden D, Goehler A, Lee H, Gazelle GS, Wiviott SD, Fleg JL, Udelson JE; ROMICAT-II Investigators. Coronary CT angiography versus standard evaluation in acute chest pain. N Engl J Med. 2012 Jul 26;367(4):299-308. doi: 10.1056/NEJMoa1201161.
- Background: PubMed 40290191Wang K, Zhang Y, Chen B, Ren H. Comparing image quality of coronary CT angiography with and without ECG-gating in wide-detector CT. Front Cardiovasc Med. 2025 Apr 11;12:1570743. doi: 10.3389/fcvm.2025.1570743. eCollection 2025.
- Background: PubMed 32029126Linde JJ, Kelbaek H, Hansen TF, Sigvardsen PE, Torp-Pedersen C, Bech J, Heitmann M, Nielsen OW, Hofsten D, Kuhl JT, Raymond IE, Kristiansen OP, Svendsen IH, Vall-Lamora MHD, Kragelund C, de Knegt M, Hove JD, Jorgensen T, Fornitz GG, Steffensen R, Jurlander B, Abdulla J, Lyngbaek S, Elming H, Therkelsen SK, Jorgensen E, Klovgaard L, Bang LE, Hansen PR, Helqvist S, Galatius S, Pedersen F, Abildgaard U, Clemmensen P, Saunamaki K, Holmvang L, Engstrom T, Gislason G, Kober LV, Kofoed KF. Coronary CT Angiography in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome. J Am Coll Cardiol. 2020 Feb 11;75(5):453-463. doi: 10.1016/j.jacc.2019.12.012.
- Background: PubMed 39468963Meier D, Andreini D, Cosyns B, Skalidis I, Storozhenko T, Mahendiran T, Assanelli E, Sonck J, Roosens B, Rotzinger DC, Qanadli SD, Tzimas G, Muller O, De Bruyne B, Collet C, Fournier S. Usefulness of FFR-CT to exclude haemodynamically significant lesions in high-risk NSTE-ACS. EuroIntervention. 2025 Jan 6;21(1):73-81. doi: 10.4244/EIJ-D-24-00779.
- Background: PubMed 34588162Gray AJ, Roobottom C, Smith JE, Goodacre S, Oatey K, O'Brien R, Storey RF, Curzen N, Keating L, Kardos A, Felmeden D, Lee RJ, Thokala P, Lewis SC, Newby DE; RAPID-CTCA Investigators. Early computed tomography coronary angiography in patients with suspected acute coronary syndrome: randomised controlled trial. BMJ. 2021 Sep 29;374:n2106. doi: 10.1136/bmj.n2106.
- Background: PubMed 37622654Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.
- Background: PubMed 40328582Thomsen B, Nabipoor A, Asadian S, Reiser I, Cotella J, Okerlund D, Challman M, Landeras L, Chalian H. Coronary computed tomography angiography without ECG leads; A feasibility study. Curr Probl Diagn Radiol. 2026 May-Jun;55(3):426-431. doi: 10.1067/j.cpradiol.2025.04.019. Epub 2025 Apr 29.
- Background: PubMed 39210710Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.
- Background: PubMed 30145934SCOT-HEART Investigators; Newby DE, Adamson PD, Berry C, Boon NA, Dweck MR, Flather M, Forbes J, Hunter A, Lewis S, MacLean S, Mills NL, Norrie J, Roditi G, Shah ASV, Timmis AD, van Beek EJR, Williams MC. Coronary CT Angiography and 5-Year Risk of Myocardial Infarction. N Engl J Med. 2018 Sep 6;379(10):924-933. doi: 10.1056/NEJMoa1805971. Epub 2018 Aug 25.
Related trials for Chest Pain
Not yet recruiting
Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery
Chest Tube Removal
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean François Argacha, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-ECG-gated computed tomography in people with Chest Pain and Acute Coronary Syndromes (ACS), run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Giangiacomi, Medical Doctor (0039 3347165451, francesco.giangiacomi@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of ECG-less CCTA for detecting obstructive coronary artery disease (defined as luminal narrowing ≥ 50%), compared to invasive coronary angiography (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07192965, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.