Coronary Artery DiseaseTARGETNCT03901326
Role of On-site CT-derived FFR in the Management of Suspect CAD Patients
A study testing CT-FFR assessment in people with Coronary Artery Disease, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The primary of this registry is to evaluate whether the availability of CTA/CT-FFR procedure could effectively optimize the flow of clinical practice of stable chest pain versus conventional clinical pathway in decision making, avoid the overuse of invasive procedure, finally improve clinical prognosis and reduce… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CT-FFR assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,216 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2019to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New-onset chest pain suspicious for CAD
- Coronary CTA result showed that the diameter stenosis is between 30 and 90% in at least one major coronary artery (coronary artery diameter ≥ 2.5 mm)
- Intermediate-to-high pretest probability of CAD based on CAD Consortium Score
- No prior evaluation for this episode of symptoms
- Agree to participate in this clinical study and sign written informed consent
Who cannot join
- Diagnosed or suspected acute coronary syndrome requiring hospitalization or emergent testing
- Hemodynamically or clinically unstable condition systolic blood pressure < 90 mmHg or serious atrial or ventricular arrhythmias
- Known CAD with prior myocardial infarction, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), or any angiographic evidence of ≥ 50% stenosis in any major coronary artery
- Patients with left main branch stenosis ≥ 50% or major coronary artery stenosis > 90%
- Known severe congenital, valvular (moderate and above), or cardiomyopathy process (hypertrophic cardiomyopathy or reduced systolic left ventricular function ≤ 40%) which could explain cardiac symptoms
- Unable to provide written informed consent or participate in long-term follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of On-site CT-derived Fractional Flow Reserve on the Management Making for the Patients With Stable Chest Pain (TARGET Trial)
The primary of this registry is to evaluate whether the availability of CTA/CT-FFR procedure could effectively optimize the flow of clinical practice of stable chest pain versus conventional clinical pathway in decision making, avoid the overuse of invasive procedure, finally improve clinical prognosis and reduce total medical expenditure. This registry is randomized, open labeled, prospective designed and will be performed in 6 Chinese hospitals. Approximately 1200 subjects will be enrolled and subsequently assigned to either routine clinically-indicated diagnostic care group (CID arm) or CTA/CT-FFR care group (CTA/CT-FFR arm) via computer-generated random numbers (1:1 ratio)
Read the detailed description
Based on the clinical fact that less stress myocardial perfusion scan are performed rather than stress exercise electrocardiogram (ECG) in China, more patients undergo coronary computed tomographic angiography (CTA) for determining whether they should be sent to catheter lab. However, nearly 30% of patients sent to catheter lab were found without obstructive coronary artery disease (CAD) and this invasive procedure was unnecessary and overused partly. Fortunately, fractional flow reserve (FFR) based non-invasive CT algorithm technology (CT-FFR) showed a great potential in detecting functional myocardial ischemia related to coronary specific lesion (Discovery-Flow, DEFACTO and NXT trial)[1-3]. Moreover, clinical care guided by CT-FFR could provide benefits with equivalent clinical outcomes and lower expenditure, compared with routine clinical care over 1-year follow-up (Platform trial). On the other aspect, ADVANCE trial revealed that CT-FFR modified treatment recommendation was associated with less negative invasive coronary angiography (ICA), predicted revascularization and identified subjects at low risk of adverse events through 90 days in real-world. However, these studies was not randomized designed and selection bias still existed. So our trial aims to evaluate whether CTA/CT-FFR outperforms the regular diagnostic care in ruling out patients without significantly obstructive CAD before catheter lab and improving clinical prognosis during follow-up in a randomized design.
- Conditions
- Coronary Artery Disease
- Being tested
- CT-FFR assessment
- Keywords
- Coronary artery disease, Coronary computed tomographic angiography, Fractional flow reserve
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-FFR assessmentDiagnostic test
When subjects are randomized to the CTA/CT-FFR arm, FFR based on the coronary CTA imaging will be measured. DEEPVESSEL FFR workstation is very dedicated software utilizing the original CTA imaging to meter simulated FFR values based on a machine learning algorithm. The first step is to extract a 3D coronary artery model and generate coronary centerlines which are similar to the routine reconstruction of coronary CTA. The centerlines are extracted using a minimal path extraction filter. Then a novel path-based deep learning model, referred to DEEPVESSEL FFR, is used to predict the simulated FFR values on the vascular centerlines. Deep learning algorithm is used to establish characteristic sample database of coronary hemodynamics characteristic parameters. When deep training model is proved to be valid, it is applied to a new lesion-specific measurement. Lesion-specific CT-FFR is defined as simulated FFR value at distance of 20mm away from the lesion of interest.
| Study group | Role | What they receive |
|---|---|---|
| CTA/CT-FFR care group | Experimental | If the subjects are randomly allocated to CT-FFR arm, they will be examined by on-site DeepFFR for three major epicardial coronary arteries. If the result of CT-FFR calculation is less than or equal to 0.8 in one or more major coronary arteries, the patient will be referred to ICA directly; if the result of CT-FFR value is more than 0.8, optimal medical therapy will be recommended. The decision on the mode of revascularization is left to the treating cardiologists and depends on local practice standard. Receives: Diagnostic Test: CT-FFR assessment |
| Routine clinically-indicated diagnostic care group | No intervention | If the subjects are randomized to usual care arm, attending physicians will decide the next step of diagnosis and treatment, such as exercise ECG, stress cardiac echo, cardiac MR, and SPECT. According to the results of examination combined with risk factors assessment and clinical manifestations, physicians should provide recommendation whether the subjects would undergo ICA or not. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With ICA Without Obstructive CAD or Intervention
Number of those patients with planned ICA in whom no significant obstructive CAD (no stenosis≥70% by core lab quantitative analysis or invasive FFR≤0.8) is found or interventions (including stent implantation, balloon dilation and bypass graft) are performed during ICA within 90 days.
Measured: 90 days
Secondary outcomes (4)
Number of Participant With Major Adverse Cardiovascular Event
Major adverse cardiovascular event include death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization
Measured: 12 months
Medical Expenditure
Overall cardiac medical expenditure by intention to treat at both 90 days and 12 months cumulatively
Measured: 12 months
Patient Reporting Outcomes
Patient reporting outcomes as measured by Seattle Angina Questionnaire-7(SAQ-7) Scale, use SAQ-7-item instrument that measures patient reported symptoms, function and quality of life for subjects with CAD within 12 months. The SAQ-7 score is calculated as the average of the physical limitation score, quality of life score and angina frequency score. The physical limitation score, quality of life score and angina frequency score range from 0 to 100 each. Therefore, the SAQ-7 score also ranges from 0 to 100.The higher the SAQ-7 socre, physical limitation score, quality of life score and angina frequency score are, the better the quality of life for patients with angina.
Measured: Study entry, 3 months, 6 months and12 months
Cumulative Radiation Exposure
Cumulative radiation exposure for any examination within 90 days and 12 months. Due to not enough data acquired, the investigators decided not to report at this time
Measured: 90 days, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start10 May 2019
- Primary completion30 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Anzhen Hospital, First Affiliated Hospital of Xinjiang Medical University, Qilu Hospital of Shandong University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Tongji Hospital
- Responsible party
- Principal investigator, Yundai Chen, Chinese PLA General Hospital
- Investigators
- Yundai Chen, Ph.D., Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901326
- Sponsor's protocol ID
- S2019-025-01
- Acronym
- TARGET
- Status last verified
- Dec 2023
- First submitted
- 30 Mar 2019
- Last updated
- 31 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Min JK, Leipsic J, Pencina MJ, Berman DS, Koo BK, van Mieghem C, Erglis A, Lin FY, Dunning AM, Apruzzese P, Budoff MJ, Cole JH, Jaffer FA, Leon MB, Malpeso J, Mancini GB, Park SJ, Schwartz RS, Shaw LJ, Mauri L. Diagnostic accuracy of fractional flow reserve from anatomic CT angiography. JAMA. 2012 Sep 26;308(12):1237-45. doi: 10.1001/2012.jama.11274.
PubMed 22922562Koo BK, Erglis A, Doh JH, Daniels DV, Jegere S, Kim HS, Dunning A, DeFrance T, Lansky A, Leipsic J, Min JK. Diagnosis of ischemia-causing coronary stenoses by noninvasive fractional flow reserve computed from coronary computed tomographic angiograms. Results from the prospective multicenter DISCOVER-FLOW (Diagnosis of Ischemia-Causing Stenoses Obtained Via Noninvasive Fractional Flow Reserve) study. J Am Coll Cardiol. 2011 Nov 1;58(19):1989-97. doi: 10.1016/j.jacc.2011.06.066.
PubMed 22032711Norgaard BL, Leipsic J, Gaur S, Seneviratne S, Ko BS, Ito H, Jensen JM, Mauri L, De Bruyne B, Bezerra H, Osawa K, Marwan M, Naber C, Erglis A, Park SJ, Christiansen EH, Kaltoft A, Lassen JF, Botker HE, Achenbach S; NXT Trial Study Group. Diagnostic performance of noninvasive fractional flow reserve derived from coronary computed tomography angiography in suspected coronary artery disease: the NXT trial (Analysis of Coronary Blood Flow Using CT Angiography: Next Steps). J Am Coll Cardiol. 2014 Apr 1;63(12):1145-1155. doi: 10.1016/j.jacc.2013.11.043. Epub 2014 Jan 30.
PubMed 24486266Douglas PS, De Bruyne B, Pontone G, Patel MR, Norgaard BL, Byrne RA, Curzen N, Purcell I, Gutberlet M, Rioufol G, Hink U, Schuchlenz HW, Feuchtner G, Gilard M, Andreini D, Jensen JM, Hadamitzky M, Chiswell K, Cyr D, Wilk A, Wang F, Rogers C, Hlatky MA; PLATFORM Investigators. 1-Year Outcomes of FFRCT-Guided Care in Patients With Suspected Coronary Disease: The PLATFORM Study. J Am Coll Cardiol. 2016 Aug 2;68(5):435-445. doi: 10.1016/j.jacc.2016.05.057.
PubMed 27470449Fairbairn TA, Nieman K, Akasaka T, Norgaard BL, Berman DS, Raff G, Hurwitz-Koweek LM, Pontone G, Kawasaki T, Sand NP, Jensen JM, Amano T, Poon M, Ovrehus K, Sonck J, Rabbat M, Mullen S, De Bruyne B, Rogers C, Matsuo H, Bax JJ, Leipsic J, Patel MR. Real-world clinical utility and impact on clinical decision-making of coronary computed tomography angiography-derived fractional flow reserve: lessons from the ADVANCE Registry. Eur Heart J. 2018 Nov 1;39(41):3701-3711. doi: 10.1093/eurheartj/ehy530.
PubMed 30165613Norgaard BL, Hjort J, Gaur S, Hansson N, Botker HE, Leipsic J, Mathiassen ON, Grove EL, Pedersen K, Christiansen EH, Kaltoft A, Gormsen LC, Maeng M, Terkelsen CJ, Kristensen SD, Krusell LR, Jensen JM. Clinical Use of Coronary CTA-Derived FFR for Decision-Making in Stable CAD. JACC Cardiovasc Imaging. 2017 May;10(5):541-550. doi: 10.1016/j.jcmg.2015.11.025. Epub 2016 Apr 13.
PubMed 27085447Colleran R, Douglas PS, Hadamitzky M, Gutberlet M, Lehmkuhl L, Foldyna B, Woinke M, Hink U, Nadjiri J, Wilk A, Wang F, Pontone G, Hlatky MA, Rogers C, Byrne RA. An FFRCT diagnostic strategy versus usual care in patients with suspected coronary artery disease planned for invasive coronary angiography at German sites: one-year results of a subgroup analysis of the PLATFORM (Prospective Longitudinal Trial of FFRCT: Outcome and Resource Impacts) study. Open Heart. 2017 Mar 22;4(1):e000526. doi: 10.1136/openhrt-2016-000526. eCollection 2017.
PubMed 28674617Collet C, Onuma Y, Andreini D, Sonck J, Pompilio G, Mushtaq S, La Meir M, Miyazaki Y, de Mey J, Gaemperli O, Ouda A, Maureira JP, Mandry D, Camenzind E, Macron L, Doenst T, Teichgraber U, Sigusch H, Asano T, Katagiri Y, Morel MA, Lindeboom W, Pontone G, Luscher TF, Bartorelli AL, Serruys PW. Coronary computed tomography angiography for heart team decision-making in multivessel coronary artery disease. Eur Heart J. 2018 Nov 1;39(41):3689-3698. doi: 10.1093/eurheartj/ehy581.
PubMed 30312411Norgaard BL, Terkelsen CJ, Mathiassen ON, Grove EL, Botker HE, Parner E, Leipsic J, Steffensen FH, Riis AH, Pedersen K, Christiansen EH, Maeng M, Krusell LR, Kristensen SD, Eftekhari A, Jakobsen L, Jensen JM. Coronary CT Angiographic and Flow Reserve-Guided Management of Patients With Stable Ischemic Heart Disease. J Am Coll Cardiol. 2018 Oct 30;72(18):2123-2134. doi: 10.1016/j.jacc.2018.07.043. Epub 2018 Aug 25.
PubMed 30153968Jensen JM, Botker HE, Mathiassen ON, Grove EL, Ovrehus KA, Pedersen KB, Terkelsen CJ, Christiansen EH, Maeng M, Leipsic J, Kaltoft A, Jakobsen L, Sorensen JT, Thim T, Kristensen SD, Krusell LR, Norgaard BL. Computed tomography derived fractional flow reserve testing in stable patients with typical angina pectoris: influence on downstream rate of invasive coronary angiography. Eur Heart J Cardiovasc Imaging. 2018 Apr 1;19(4):405-414. doi: 10.1093/ehjci/jex068.
PubMed 28444153Ding Y, Liu Z, Shan D, Wang X, Guo Z, Xin R, Xu L, Zhang M, Hu X, Liu H, Chen Y, Yang J, Target Investigators OBOT. Sex differences in computed tomography-derived fractional flow reserve-guided management of stable coronary artery disease: a subgroup analysis of the TARGET trial. EuroIntervention. 2026 Sep 7;22(17):e946-e954. doi: 10.4244/EIJ-D-25-01383.
PubMed 42703765Yang J, Shan D, Wang X, Sun X, Shao M, Wang K, Pan Y, Wang Z, Schoepf UJ, Savage RH, Zhang M, Dong M, Xu L, Zhou Y, Ma X, Hu X, Xia L, Zeng H, Liu Z, Chen Y. On-Site Computed Tomography-Derived Fractional Flow Reserve to Guide Management of Patients With Stable Coronary Artery Disease: The TARGET Randomized Trial. Circulation. 2023 May 2;147(18):1369-1381. doi: 10.1161/CIRCULATIONAHA.123.063996. Epub 2023 Mar 4.
PubMed 36870065Yang J, Shan D, Dong M, Wang Z, Ma X, Hu X, Zeng H, Chen Y. The effect of on-site CT-derived fractional flow reserve on the management of decision making for patients with stable chest pain (TARGET trial): objective, rationale, and design. Trials. 2020 Aug 20;21(1):728. doi: 10.1186/s13063-020-04649-9.
PubMed 32819429
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of On-site CT-derived Fractional Flow Reserve on the Management Making for the Patients With Stable Chest Pain (TARGET Trial)
- ClinicalTrials.gov ID
- NCT03901326
- Acronym / sponsor ID
- TARGET / S2019-025-01
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Coronary computed tomographic angiography, Fractional flow reserve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,216 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Beijing Anzhen Hospital, First Affiliated Hospital of Xinjiang Medical University, Qilu Hospital of Shandong University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Tongji Hospital
- Study start
- 10 May 2019 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Posted 31 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary of this registry is to evaluate whether the availability of CTA/CT-FFR procedure could effectively optimize the flow of clinical practice of stable chest pain versus conventional clinical pathway in decision making, avoid the overuse of invasive procedure, finally improve clinical prognosis and reduce total medical expenditure. This registry is randomized, open labeled, prospective designed and will be performed in 6 Chinese hospitals. Approximately 1200 subjects will be enrolled and subsequently assigned to either routine clinically-indicated diagnostic care group (CID arm) or CTA/CT-FFR care group (CTA/CT-FFR arm) via computer-generated random numbers (1:1 ratio)
Detailed description
Based on the clinical fact that less stress myocardial perfusion scan are performed rather than stress exercise electrocardiogram (ECG) in China, more patients undergo coronary computed tomographic angiography (CTA) for determining whether they should be sent to catheter lab. However, nearly 30% of patients sent to catheter lab were found without obstructive coronary artery disease (CAD) and this invasive procedure was unnecessary and overused partly. Fortunately, fractional flow reserve (FFR) based non-invasive CT algorithm technology (CT-FFR) showed a great potential in detecting functional myocardial ischemia related to coronary specific lesion (Discovery-Flow, DEFACTO and NXT trial)[1-3]. Moreover, clinical care guided by CT-FFR could provide benefits with equivalent clinical outcomes and lower expenditure, compared with routine clinical care over 1-year follow-up (Platform trial). On the other aspect, ADVANCE trial revealed that CT-FFR modified treatment recommendation was associated with less negative invasive coronary angiography (ICA), predicted revascularization and identified subjects at low risk of adverse events through 90 days in real-world. However, these studies was not randomized designed and selection bias still existed. So our trial aims to evaluate whether CTA/CT-FFR outperforms the regular diagnostic care in ruling out patients without significantly obstructive CAD before catheter lab and improving clinical prognosis during follow-up in a randomized design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTA/CT-FFR care group | Experimental | Diagnostic Test: CT-FFR assessmentIf the subjects are randomly allocated to CT-FFR arm, they will be examined by on-site DeepFFR for three major epicardial coronary arteries. If the result of CT-FFR calculation is less than or equal to 0.8 in one or more major coronary arteries, the patient will be referred to ICA directly; if the result of CT-FFR value is more than 0.8, optimal medical therapy will be recommended. The decision on the mode of revascularization is left to the treating cardiologists and depends on local practice standard. |
| Routine clinically-indicated diagnostic care group | No intervention | –If the subjects are randomized to usual care arm, attending physicians will decide the next step of diagnosis and treatment, such as exercise ECG, stress cardiac echo, cardiac MR, and SPECT. According to the results of examination combined with risk factors assessment and clinical manifestations, physicians should provide recommendation whether the subjects would undergo ICA or not. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- New-onset chest pain suspicious for CAD
- Coronary CTA result showed that the diameter stenosis is between 30 and 90% in at least one major coronary artery (coronary artery diameter ≥ 2.5 mm)
- Intermediate-to-high pretest probability of CAD based on CAD Consortium Score
- No prior evaluation for this episode of symptoms
- Agree to participate in this clinical study and sign written informed consent
Key exclusion criteria (6 listed)
- Diagnosed or suspected acute coronary syndrome requiring hospitalization or emergent testing
- Hemodynamically or clinically unstable condition systolic blood pressure < 90 mmHg or serious atrial or ventricular arrhythmias
- Known CAD with prior myocardial infarction, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), or any angiographic evidence of ≥ 50% stenosis in any major coronary artery
- Patients with left main branch stenosis ≥ 50% or major coronary artery stenosis > 90%
- Known severe congenital, valvular (moderate and above), or cardiomyopathy process (hypertrophic cardiomyopathy or reduced systolic left ventricular function ≤ 40%) which could explain cardiac symptoms
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 |
|---|---|---|
| CT-FFR assessmentWhen subjects are randomized to the CTA/CT-FFR arm, FFR based on the coronary CTA imaging will be measured. DEEPVESSEL FFR workstation is very dedicated software utilizing the original CTA imaging to meter simulated FFR values based on a machine learning algorithm. The first step is to extract a 3D coronary artery model and generate coronary centerlines which are similar to the routine reconstruction of coronary CTA. The centerlines are extracted using a minimal path extraction filter. Then a novel path-based deep learning model, referred to DEEPVESSEL FFR, is used to predict the simulated FFR values on the vascular centerlines. Deep learning algorithm is used to establish characteristic sample database of coronary hemodynamics characteristic parameters. When deep training model is proved to be valid, it is applied to a new lesion-specific measurement. Lesion-specific CT-FFR is defined as simulated FFR value at distance of 20mm away from the lesion of interest. | Diagnostic test | CTA/CT-FFR care group |
Primary outcome
Number of Participants With ICA Without Obstructive CAD or Intervention
Time frame: 90 days
Number of those patients with planned ICA in whom no significant obstructive CAD (no stenosis≥70% by core lab quantitative analysis or invasive FFR≤0.8) is found or interventions (including stent implantation, balloon dilation and bypass graft) are performed during ICA within 90 days.
4 secondary outcomes
Number of Participant With Major Adverse Cardiovascular Event
Time frame: 12 months
Medical Expenditure
Time frame: 12 months
Patient Reporting Outcomes
Time frame: Study entry, 3 months, 6 months and12 months
Cumulative Radiation Exposure
Time frame: 90 days, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22922562Min JK, Leipsic J, Pencina MJ, Berman DS, Koo BK, van Mieghem C, Erglis A, Lin FY, Dunning AM, Apruzzese P, Budoff MJ, Cole JH, Jaffer FA, Leon MB, Malpeso J, Mancini GB, Park SJ, Schwartz RS, Shaw LJ, Mauri L. Diagnostic accuracy of fractional flow reserve from anatomic CT angiography. JAMA. 2012 Sep 26;308(12):1237-45. doi: 10.1001/2012.jama.11274.
- Background: PubMed 22032711Koo BK, Erglis A, Doh JH, Daniels DV, Jegere S, Kim HS, Dunning A, DeFrance T, Lansky A, Leipsic J, Min JK. Diagnosis of ischemia-causing coronary stenoses by noninvasive fractional flow reserve computed from coronary computed tomographic angiograms. Results from the prospective multicenter DISCOVER-FLOW (Diagnosis of Ischemia-Causing Stenoses Obtained Via Noninvasive Fractional Flow Reserve) study. J Am Coll Cardiol. 2011 Nov 1;58(19):1989-97. doi: 10.1016/j.jacc.2011.06.066.
- Background: PubMed 24486266Norgaard BL, Leipsic J, Gaur S, Seneviratne S, Ko BS, Ito H, Jensen JM, Mauri L, De Bruyne B, Bezerra H, Osawa K, Marwan M, Naber C, Erglis A, Park SJ, Christiansen EH, Kaltoft A, Lassen JF, Botker HE, Achenbach S; NXT Trial Study Group. Diagnostic performance of noninvasive fractional flow reserve derived from coronary computed tomography angiography in suspected coronary artery disease: the NXT trial (Analysis of Coronary Blood Flow Using CT Angiography: Next Steps). J Am Coll Cardiol. 2014 Apr 1;63(12):1145-1155. doi: 10.1016/j.jacc.2013.11.043. Epub 2014 Jan 30.
- Background: PubMed 27470449Douglas PS, De Bruyne B, Pontone G, Patel MR, Norgaard BL, Byrne RA, Curzen N, Purcell I, Gutberlet M, Rioufol G, Hink U, Schuchlenz HW, Feuchtner G, Gilard M, Andreini D, Jensen JM, Hadamitzky M, Chiswell K, Cyr D, Wilk A, Wang F, Rogers C, Hlatky MA; PLATFORM Investigators. 1-Year Outcomes of FFRCT-Guided Care in Patients With Suspected Coronary Disease: The PLATFORM Study. J Am Coll Cardiol. 2016 Aug 2;68(5):435-445. doi: 10.1016/j.jacc.2016.05.057.
- Background: PubMed 30165613Fairbairn TA, Nieman K, Akasaka T, Norgaard BL, Berman DS, Raff G, Hurwitz-Koweek LM, Pontone G, Kawasaki T, Sand NP, Jensen JM, Amano T, Poon M, Ovrehus K, Sonck J, Rabbat M, Mullen S, De Bruyne B, Rogers C, Matsuo H, Bax JJ, Leipsic J, Patel MR. Real-world clinical utility and impact on clinical decision-making of coronary computed tomography angiography-derived fractional flow reserve: lessons from the ADVANCE Registry. Eur Heart J. 2018 Nov 1;39(41):3701-3711. doi: 10.1093/eurheartj/ehy530.
- Background: PubMed 27085447Norgaard BL, Hjort J, Gaur S, Hansson N, Botker HE, Leipsic J, Mathiassen ON, Grove EL, Pedersen K, Christiansen EH, Kaltoft A, Gormsen LC, Maeng M, Terkelsen CJ, Kristensen SD, Krusell LR, Jensen JM. Clinical Use of Coronary CTA-Derived FFR for Decision-Making in Stable CAD. JACC Cardiovasc Imaging. 2017 May;10(5):541-550. doi: 10.1016/j.jcmg.2015.11.025. Epub 2016 Apr 13.
- Background: PubMed 28674617Colleran R, Douglas PS, Hadamitzky M, Gutberlet M, Lehmkuhl L, Foldyna B, Woinke M, Hink U, Nadjiri J, Wilk A, Wang F, Pontone G, Hlatky MA, Rogers C, Byrne RA. An FFRCT diagnostic strategy versus usual care in patients with suspected coronary artery disease planned for invasive coronary angiography at German sites: one-year results of a subgroup analysis of the PLATFORM (Prospective Longitudinal Trial of FFRCT: Outcome and Resource Impacts) study. Open Heart. 2017 Mar 22;4(1):e000526. doi: 10.1136/openhrt-2016-000526. eCollection 2017.
- Background: PubMed 30312411Collet C, Onuma Y, Andreini D, Sonck J, Pompilio G, Mushtaq S, La Meir M, Miyazaki Y, de Mey J, Gaemperli O, Ouda A, Maureira JP, Mandry D, Camenzind E, Macron L, Doenst T, Teichgraber U, Sigusch H, Asano T, Katagiri Y, Morel MA, Lindeboom W, Pontone G, Luscher TF, Bartorelli AL, Serruys PW. Coronary computed tomography angiography for heart team decision-making in multivessel coronary artery disease. Eur Heart J. 2018 Nov 1;39(41):3689-3698. doi: 10.1093/eurheartj/ehy581.
- Background: PubMed 30153968Norgaard BL, Terkelsen CJ, Mathiassen ON, Grove EL, Botker HE, Parner E, Leipsic J, Steffensen FH, Riis AH, Pedersen K, Christiansen EH, Maeng M, Krusell LR, Kristensen SD, Eftekhari A, Jakobsen L, Jensen JM. Coronary CT Angiographic and Flow Reserve-Guided Management of Patients With Stable Ischemic Heart Disease. J Am Coll Cardiol. 2018 Oct 30;72(18):2123-2134. doi: 10.1016/j.jacc.2018.07.043. Epub 2018 Aug 25.
- Background: PubMed 28444153Jensen JM, Botker HE, Mathiassen ON, Grove EL, Ovrehus KA, Pedersen KB, Terkelsen CJ, Christiansen EH, Maeng M, Leipsic J, Kaltoft A, Jakobsen L, Sorensen JT, Thim T, Kristensen SD, Krusell LR, Norgaard BL. Computed tomography derived fractional flow reserve testing in stable patients with typical angina pectoris: influence on downstream rate of invasive coronary angiography. Eur Heart J Cardiovasc Imaging. 2018 Apr 1;19(4):405-414. doi: 10.1093/ehjci/jex068.
- Derived from this study: PubMed 42703765Ding Y, Liu Z, Shan D, Wang X, Guo Z, Xin R, Xu L, Zhang M, Hu X, Liu H, Chen Y, Yang J, Target Investigators OBOT. Sex differences in computed tomography-derived fractional flow reserve-guided management of stable coronary artery disease: a subgroup analysis of the TARGET trial. EuroIntervention. 2026 Sep 7;22(17):e946-e954. doi: 10.4244/EIJ-D-25-01383.
- Derived from this study: PubMed 36870065Yang J, Shan D, Wang X, Sun X, Shao M, Wang K, Pan Y, Wang Z, Schoepf UJ, Savage RH, Zhang M, Dong M, Xu L, Zhou Y, Ma X, Hu X, Xia L, Zeng H, Liu Z, Chen Y. On-Site Computed Tomography-Derived Fractional Flow Reserve to Guide Management of Patients With Stable Coronary Artery Disease: The TARGET Randomized Trial. Circulation. 2023 May 2;147(18):1369-1381. doi: 10.1161/CIRCULATIONAHA.123.063996. Epub 2023 Mar 4.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yundai Chen, Ph.D. principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-FFR assessment in people with Coronary Artery Disease, run by Chinese PLA General Hospital at 1 site in China.
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 6 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: finished, as of the sponsor's last update on 31 May 2024. 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 China. 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?
Yes. Results are posted in the registry (first posted 31 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With ICA Without Obstructive CAD or Intervention (time frame: 90 days). 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 NCT03901326, which also lists 13 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 31 May 2024.