Chest PainE-CCTANCT07140419
Coronary Computed Tomographic Angiography Combined With CT-FFR in Intermediate-Risk Chest Pain Patients.
A study testing Coronary computed tomographic angiography with CT - derived fractional flow reserve in people with Chest Pain and Coronary Artery Disease, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
This study aims to investigate the guiding value of coronary CTA combined with CT-FFR in diagnostic and treatment decision-making for emergency chest pain patients at moderate risk, as well as its impact on clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain, Coronary Artery Disease, Emergency Department
- What is being tested?
- Coronary computed tomographic angiography with CT - derived fractional flow reserve
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 30 Jun 2032
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years；
- Within 24 hours of presenting to the emergency department (ED) with chest pain or other symptoms suggestive of coronary artery disease (CAD)；
- HEART-score >3 (according to http://www.heartscore.nl/)；
- Signed written informed consent.
Who cannot join
- Inability to obtain informed consent；
- Acute Coronary Syndromes (ACS) requiring urgent revascularization；
- Known Obstructive Coronary Artery Disease (CAD) or previous PCI or CABG;
- Concomitant severe congestive heart failure (New York Heart Association [NYHA] class III-IV or left ventricular ejection fraction [LVEF] < 30%) or acute pulmonary edema;
- Severe hepatic insufficiency (Child-Pugh score ≥ C, or aspartate aminotransferase [AST] > 5× upper limit of normal); severe renal insufficiency (estimated glomerular filtration rate [eGFR] ≤ 30 mL/min/1.73 m²) or patients receiving continuous renal replacement therapy, hemodialysis, or peritoneal dialysis;
- History of prior coronary artery bypass grafting (CABG);
Show all 11Show fewer
- Severe allergy to iodinated contrast agents;
- Inability to obtain high-quality imaging;
- Pregnant or lactating females;
- Concomitant diseases or limited life expectancy, quality of life, or functional status precluding further CAD evaluation;
- Any other factors that, in the investigator's judgment, make the patient unsuitable for study enrollment, completion of the study, or follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chuanbao Li
Jinan, Shandong, 250000
Chuanbao Li, +86 18560083097, bao2460@126.com
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Trial on the Impact of Coronary CTA Combined With CT-FFR on Diagnosis and Treatment Decisions and Clinical Outcomes in Emergency Patients With Intermediate Risk Chest Pain
This study aims to investigate the guiding value of coronary CTA combined with CT-FFR in diagnostic and treatment decision-making for emergency chest pain patients at moderate risk, as well as its impact on clinical outcomes. Through a prospective multicenter randomized controlled trial, this research compares the preventive effects of early application of this technology versus standard care on major adverse cardiovascular and cerebrovascular events (MACCE), with the goal of optimizing the diagnostic and treatment processes for emergency chest pain patients.
Read the detailed description
This study involves intermediate-risk emergency department patients presenting with chest pain or symptoms suggestive of acute coronary syndrome (ACS) but without acute myocardial infarction (AMI), defined by a HEART score greater than 3. After providing written informed consent, these patients are randomized to one of two strategies: an initial approach incorporating early coronary computed tomographic angiography (CCTA) or a standard care pathway without early CCTA. Patients in the CCTA group receive standard care as determined by their treating physician and undergo CCTA as soon as possible, typically within 24 hours and at most within 21 days. The results of the CCTA, including coronary artery stenosis severity and CT-derived fractional flow reserve (CT-FFR) values, are provided to the physician to inform further management, which may include invasive coronary angiography, medical therapy, or lifestyle interventions.
In contrast, patients randomized to the standard care group without early CCTA proceed with physician-directed evaluations that may include non-invasive functional tests such as exercise electrocardiography, stress echocardiography, or nuclear imaging according to local clinical practices, though CCTA is not part of their initial workup. Both groups receive optimal preventive care in line with current guidelines, and treating physicians are encouraged to initiate secondary prevention measures like antiplatelet therapy or statin use if any diagnostic tests reveal signs of coronary artery disease (CAD).
The primary endpoint of the study is a composite of death, readmission due to myocardial infarction, or hospitalization for unstable angina requiring revascularization. The trial aims to determine whether an early CCTA strategy improves diagnostic and treatment decision-making for intermediate-risk chest pain patients, ultimately influencing clinical outcomes compared to standard care. The study incorporates a prospective, multicenter design to ensure broad applicability and rigor, with careful attention to patient safety and adherence to ethical standards throughout the enrollment and follow-up processes.
- Conditions
- Chest Pain, Coronary Artery Disease, Emergency Department
- Being tested
- Coronary computed tomographic angiography with CT - derived fractional flow reserve
- Keywords
- Intermediate Risk Chest Pain, Emergency Department, CCTA, CT-FFR, Coronary Artery Disease
- Medical subject headings
- Chest Pain, Coronary Artery Disease, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary computed tomographic angiography with CT - derived fractional flow reserveDiagnostic test
A non-invasive coronary computed tomography angiography (CCTA) protocol that visualizes coronary anatomy to evaluate the presence, location, and severity of atherosclerotic stenosis, coupled with CT-derived fractional flow reserve (CT-FFR) analysis-a computational fluid dynamics method applied to CCTA datasets-to assess the hemodynamic significance of identified stenoses and identify lesions likely to induce myocardial ischemia.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Patients receive early coronary computed tomographic angiography (CCTA) combined with CT-derived fractional flow reserve (CT-FFR) to guide diagnostic and treatment decisions, in addition to standard care. Receives: Diagnostic Test: Coronary computed tomographic angiography with CT - derived fractional flow reserve |
| Control Arm | No intervention | Patients receive standard care without early CCTA, with further management determined at the discretion of their treating physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Major adverse cardiovascular and cerebrovascular events (MACCE), defined as the composite endpoint of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and unstable angina pectoris
Major adverse cardiovascular and cerebrovascular events (MACCE), a pivotal composite endpoint in cardiovascular clinical trials, are defined as the aggregate occurrence of cardiovascular death, nonfatal ST - elevation or non - ST - elevation myocardial infarction (reflecting ischemic myocardial injury), nonfatal ischemic or hemorrhagic stroke (denoting cerebrovascular ischemia or hemorrhage), coronary revascularization (encompassing percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG] for obstructive coronary lesions), and unstable angina pectoris (characterized by new - onset or crescendo chest pain indicative of acute coronary syndrome without myocardial necrosis).
Measured: The enrollment phase will last for 2 years, and follow-up for all participants will continue until 12 months after the last participant is enrolled.
Secondary outcomes (9)
Incidence of Recurrent Emergency Department Visit for Chest Pain
Re-presentation with chest pain as the main complaint
Measured: The enrollment phase will last for 2 years, and follow-up for all participants will continue until 12 months after the last participant is enrolled
Hospitalization Rate due to Chest Pain or Stroke
Measured: 1 month; the enrollment phase will last for 2 years, and follow-up for all participants will continue until 12 months after the last participant is enrolled
Incidence of All-cause mortality
All-cause mortality (cardiovascular death, non-cardiovascular death, death of undetermined cause)
Measured: The enrollment phase will last for 2 years, and follow-up for all participants will continue until 12 months after the last participant is enrolled.
Proportion of Patients Undergoing Invasive Coronary Angiography
Measured: The enrollment phase will last for 2 years, and follow-up for all participants will continue until 12 months after the last participant is enrolled.
Proportion of Patients with Non-Obstructive CAD at Invasive Coronary Angiography
Measured: The enrollment phase will last for 2 years, and follow-up for all participants will continue until 12 months after the last participant is enrolled.
Effect of an Early CCTA with CT-FFR Diagnostic Strategy on Preventive Medication Utilization (antiplatelet agents, lipid-lowering therapies) in Intermediate-Risk Emergency Department Chest Pain Patients
Utilization of preventive medications (antiplatelet agents, lipid-lowering therapies), including antiplatelet therapy, statins, and antihypertensive agents.
Measured: 1 Year, 2 Year, 3 Year, 4 Year, and 5 Year.
Health economic evaluation endpoints
Including Direct Medical Costs, Direct Non-Medical Costs and Indirect Costs. Costs will be standardized to 2025 Chinese Yuan using national health service price indices.
Measured: 1 Year and 5 Year
Quality of Life Assessed by the Seattle Angina Questionnaire (SAQ)
The Seattle Angina Questionnaire (SAQ) is a validated, patient-reported instrument assessing functional status and quality of life in patients with coronary artery disease. Scores range from 0 to 100, with higher scores indicating better health status and quality of life. Change from baseline to follow-up will be measured.
Measured: 1 Year and 5 Year
Quality of Life Assessed by the EQ-5D Index Scores
The EuroQol 5-Dimension (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. The EQ-5D index score ranges from -0.594 (worst health state) to 1.0 (perfect health). Higher scores indicate better health utility. Change from baseline to follow-up will be measured.
Measured: 1 Year and 5 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Apr 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients presenting to the emergency department (ED) with chest pain or other symptoms suggestive of acute coronary syndrome (ACS), who have intermediate risk (defined by a HEART score \> 3) and no acute myocardial infarction (MI), will be randomized to one of two strategies after providing written informed consent: an initial approach involving coronary computed tomographic angiography (CCTA) or a standard care pathway without early CCTA.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Beijing Anzhen Hospital, JiNing NO.1 People Hospital, Zhun Ge Er Qi Central Hospital
- Responsible party
- Principal investigator, Chuanbao Li, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140419
- Sponsor's protocol ID
- KYLL-202412(XZ)-014-3
- Acronym
- E-CCTA
- Status last verified
- Mar 2026
- First submitted
- 12 Aug 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gulati M, Levy PD, Mukherjee D, Amsterdam E, Bhatt DL, Birtcher KK, Blankstein R, Boyd J, Bullock-Palmer RP, Conejo T, Diercks DB, Gentile F, Greenwood JP, Hess EP, Hollenberg SM, Jaber WA, Jneid H, Joglar JA, Morrow DA, O'Connor RE, Ross MA, Shaw LJ. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021 Nov 30;144(22):e368-e454. doi: 10.1161/CIR.0000000000001029. Epub 2021 Oct 28.
PubMed 34709879Hoffmann 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 22830462Gongora CA, Bavishi C, Uretsky S, Argulian E. Acute chest pain evaluation using coronary computed tomography angiography compared with standard of care: a meta-analysis of randomised clinical trials. Heart. 2018 Feb;104(3):215-221. doi: 10.1136/heartjnl-2017-311647. Epub 2017 Aug 30.
PubMed 28855273Foy AJ, Dhruva SS, Peterson B, Mandrola JM, Morgan DJ, Redberg RF. Coronary Computed Tomography Angiography vs Functional Stress Testing for Patients With Suspected Coronary Artery Disease: A Systematic Review and Meta-analysis. JAMA Intern Med. 2017 Nov 1;177(11):1623-1631. doi: 10.1001/jamainternmed.2017.4772.
PubMed 28973101SCOT-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 30145934Moss AJ, Williams MC, Newby DE, Nicol ED. The Updated NICE Guidelines: Cardiac CT as the First-Line Test for Coronary Artery Disease. Curr Cardiovasc Imaging Rep. 2017;10(5):15. doi: 10.1007/s12410-017-9412-6. Epub 2017 Mar 27.
PubMed 28446943Goodacre S, Thokala P, Carroll C, Stevens JW, Leaviss J, Al Khalaf M, Collinson P, Morris F, Evans P, Wang J. Systematic review, meta-analysis and economic modelling of diagnostic strategies for suspected acute coronary syndrome. Health Technol Assess. 2013;17(1):v-vi, 1-188. doi: 10.3310/hta17010.
PubMed 23331845Mowatt G, Cummins E, Waugh N, Walker S, Cook J, Jia X, Hillis GS, Fraser C. Systematic review of the clinical effectiveness and cost-effectiveness of 64-slice or higher computed tomography angiography as an alternative to invasive coronary angiography in the investigation of coronary artery disease. Health Technol Assess. 2008 May;12(17):iii-iv, ix-143. doi: 10.3310/hta12170.
PubMed 18462576Ljung L, Lindahl B, Eggers KM, Frick M, Linder R, Lofmark HB, Martinsson A, Melki D, Sarkar N, Svensson P, Jernberg T. A Rule-Out Strategy Based on High-Sensitivity Troponin and HEART Score Reduces Hospital Admissions. Ann Emerg Med. 2019 May;73(5):491-499. doi: 10.1016/j.annemergmed.2018.11.039. Epub 2019 Jan 17.
PubMed 30661856Shen C, Ge J. Epidemic of Cardiovascular Disease in China: Current Perspective and Prospects for the Future. Circulation. 2018 Jul 24;138(4):342-344. doi: 10.1161/CIRCULATIONAHA.118.033484. No abstract available.
PubMed 30571361
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Trial on the Impact of Coronary CTA Combined With CT-FFR on Diagnosis and Treatment Decisions and Clinical Outcomes in Emergency Patients With Intermediate Risk Chest Pain
- ClinicalTrials.gov ID
- NCT07140419
- Acronym / sponsor ID
- E-CCTA / KYLL-202412(XZ)-014-3
- Conditions
- Chest Pain, Coronary Artery Disease, Emergency Department
- Keywords
- Intermediate Risk Chest Pain, Emergency Department, CCTA, CT-FFR, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Beijing Anzhen Hospital, JiNing NO.1 People Hospital, Zhun Ge Er Qi Central Hospital
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 24 Aug 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.
This study aims to investigate the guiding value of coronary CTA combined with CT-FFR in diagnostic and treatment decision-making for emergency chest pain patients at moderate risk, as well as its impact on clinical outcomes. Through a prospective multicenter randomized controlled trial, this research compares the preventive effects of early application of this technology versus standard care on major adverse cardiovascular and cerebrovascular events (MACCE), with the goal of optimizing the diagnostic and treatment processes for emergency chest pain patients.
Detailed description
This study involves intermediate-risk emergency department patients presenting with chest pain or symptoms suggestive of acute coronary syndrome (ACS) but without acute myocardial infarction (AMI), defined by a HEART score greater than 3. After providing written informed consent, these patients are randomized to one of two strategies: an initial approach incorporating early coronary computed tomographic angiography (CCTA) or a standard care pathway without early CCTA. Patients in the CCTA group receive standard care as determined by their treating physician and undergo CCTA as soon as possible, typically within 24 hours and at most within 21 days. The results of the CCTA, including coronary artery stenosis severity and CT-derived fractional flow reserve (CT-FFR) values, are provided to the physician to inform further management, which may include invasive coronary angiography, medical therapy, or lifestyle interventions.
In contrast, patients randomized to the standard care group without early CCTA proceed with physician-directed evaluations that may include non-invasive functional tests such as exercise electrocardiography, stress echocardiography, or nuclear imaging according to local clinical practices, though CCTA is not part of their initial workup. Both groups receive optimal preventive care in line with current guidelines, and treating physicians are encouraged to initiate secondary prevention measures like antiplatelet therapy or statin use if any diagnostic tests reveal signs of coronary artery disease (CAD).
The primary endpoint of the study is a composite of death, readmission due to myocardial infarction, or hospitalization for unstable angina requiring revascularization. The trial aims to determine whether an early CCTA strategy improves diagnostic and treatment decision-making for intermediate-risk chest pain patients, ultimately influencing clinical outcomes compared to standard care. The study incorporates a prospective, multicenter design to ensure broad applicability and rigor, with careful attention to patient safety and adherence to ethical standards throughout the enrollment and follow-up processes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients presenting to the emergency department (ED) with chest pain or other symptoms suggestive of acute coronary syndrome (ACS), who have intermediate risk (defined by a HEART score > 3) and no acute myocardial infarction (MI), will be randomized to one of two strategies after providing written informed consent: an initial approach involving coronary computed tomographic angiography (CCTA) or a standard care pathway without early CCTA.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Diagnostic Test: Coronary computed tomographic angiography with CT - derived fractional flow reservePatients receive early coronary computed tomographic angiography (CCTA) combined with CT-derived fractional flow reserve (CT-FFR) to guide diagnostic and treatment decisions, in addition to standard care. |
| Control Arm | No intervention | –Patients receive standard care without early CCTA, with further management determined at the discretion of their treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age≥18 years；
- Within 24 hours of presenting to the emergency department (ED) with chest pain or other symptoms suggestive of coronary artery disease (CAD)；
- HEART-score >3 (according to http://www.heartscore.nl/)；
- Signed written informed consent.
Key exclusion criteria (11 listed)
- Inability to obtain informed consent；
- Acute Coronary Syndromes (ACS) requiring urgent revascularization；
- Known Obstructive Coronary Artery Disease (CAD) or previous PCI or CABG;
- Concomitant severe congestive heart failure (New York Heart Association [NYHA] class III-IV or left ventricular ejection fraction [LVEF] < 30%) or acute pulmonary edema;
- Severe hepatic insufficiency (Child-Pugh score ≥ C, or aspartate aminotransferase [AST] > 5× upper limit of normal); severe renal insufficiency (estimated glomerular filtration rate [eGFR] ≤ 30 mL/min/1.73 m²) or patients receiving continuous renal replacement therapy, hemodialysis, or peritoneal dialysis;
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 |
|---|---|---|
| Coronary computed tomographic angiography with CT - derived fractional flow reserveA non-invasive coronary computed tomography angiography (CCTA) protocol that visualizes coronary anatomy to evaluate the presence, location, and severity of atherosclerotic stenosis, coupled with CT-derived fractional flow reserve (CT-FFR) analysis-a computational fluid dynamics method applied to CCTA datasets-to assess the hemodynamic significance of identified stenoses and identify lesions likely to induce myocardial ischemia. | Diagnostic test | Experimental Arm |
Primary outcome
Incidence of Major adverse cardiovascular and cerebrovascular events (MACCE), defined as the composite endpoint of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and unstable angina pectoris
Time frame: The enrollment phase will last for 2 years, and follow-up for all participants will continue until 12 months after the last participant is enrolled.
Major adverse cardiovascular and cerebrovascular events (MACCE), a pivotal composite endpoint in cardiovascular clinical trials, are defined as the aggregate occurrence of cardiovascular death, nonfatal ST - elevation or non - ST - elevation myocardial infarction (reflecting ischemic myocardial injury), nonfatal ischemic or hemorrhagic stroke (denoting cerebrovascular ischemia or hemorrhage), coronary revascularization (encompassing percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG] for obstructive coronary lesions), and unstable angina pectoris (characterized by new - onset or crescendo chest pain indicative of acute coronary syndrome without myocardial necrosis).
9 secondary outcomes
Incidence of Recurrent Emergency Department Visit for Chest Pain
Time frame: The enrollment phase will last for 2 years, and follow-up for all participants will continue until 12 months after the last participant is enrolled
Hospitalization Rate due to Chest Pain or Stroke
Time frame: 1 month; the enrollment phase will last for 2 years, and follow-up for all participants will continue until 12 months after the last participant is enrolled
Incidence of All-cause mortality
Time frame: The enrollment phase will last for 2 years, and follow-up for all participants will continue until 12 months after the last participant is enrolled.
Proportion of Patients Undergoing Invasive Coronary Angiography
Time frame: The enrollment phase will last for 2 years, and follow-up for all participants will continue until 12 months after the last participant is enrolled.
Proportion of Patients with Non-Obstructive CAD at Invasive Coronary Angiography
Time frame: The enrollment phase will last for 2 years, and follow-up for all participants will continue until 12 months after the last participant is enrolled.
Effect of an Early CCTA with CT-FFR Diagnostic Strategy on Preventive Medication Utilization (antiplatelet agents, lipid-lowering therapies) in Intermediate-Risk Emergency Department Chest Pain Patients
Time frame: 1 Year, 2 Year, 3 Year, 4 Year, and 5 Year.
Health economic evaluation endpoints
Time frame: 1 Year and 5 Year
Quality of Life Assessed by the Seattle Angina Questionnaire (SAQ)
Time frame: 1 Year and 5 Year
Quality of Life Assessed by the EQ-5D Index Scores
Time frame: 1 Year and 5 Year
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 20 Mar 2026.
- Background: PubMed 34709879Gulati M, Levy PD, Mukherjee D, Amsterdam E, Bhatt DL, Birtcher KK, Blankstein R, Boyd J, Bullock-Palmer RP, Conejo T, Diercks DB, Gentile F, Greenwood JP, Hess EP, Hollenberg SM, Jaber WA, Jneid H, Joglar JA, Morrow DA, O'Connor RE, Ross MA, Shaw LJ. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021 Nov 30;144(22):e368-e454. doi: 10.1161/CIR.0000000000001029. Epub 2021 Oct 28.
- 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 28855273Gongora CA, Bavishi C, Uretsky S, Argulian E. Acute chest pain evaluation using coronary computed tomography angiography compared with standard of care: a meta-analysis of randomised clinical trials. Heart. 2018 Feb;104(3):215-221. doi: 10.1136/heartjnl-2017-311647. Epub 2017 Aug 30.
- Background: PubMed 28973101Foy AJ, Dhruva SS, Peterson B, Mandrola JM, Morgan DJ, Redberg RF. Coronary Computed Tomography Angiography vs Functional Stress Testing for Patients With Suspected Coronary Artery Disease: A Systematic Review and Meta-analysis. JAMA Intern Med. 2017 Nov 1;177(11):1623-1631. doi: 10.1001/jamainternmed.2017.4772.
- 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.
- Background: PubMed 28446943Moss AJ, Williams MC, Newby DE, Nicol ED. The Updated NICE Guidelines: Cardiac CT as the First-Line Test for Coronary Artery Disease. Curr Cardiovasc Imaging Rep. 2017;10(5):15. doi: 10.1007/s12410-017-9412-6. Epub 2017 Mar 27.
- Background: PubMed 23331845Goodacre S, Thokala P, Carroll C, Stevens JW, Leaviss J, Al Khalaf M, Collinson P, Morris F, Evans P, Wang J. Systematic review, meta-analysis and economic modelling of diagnostic strategies for suspected acute coronary syndrome. Health Technol Assess. 2013;17(1):v-vi, 1-188. doi: 10.3310/hta17010.
- Background: PubMed 18462576Mowatt G, Cummins E, Waugh N, Walker S, Cook J, Jia X, Hillis GS, Fraser C. Systematic review of the clinical effectiveness and cost-effectiveness of 64-slice or higher computed tomography angiography as an alternative to invasive coronary angiography in the investigation of coronary artery disease. Health Technol Assess. 2008 May;12(17):iii-iv, ix-143. doi: 10.3310/hta12170.
- Background: PubMed 30661856Ljung L, Lindahl B, Eggers KM, Frick M, Linder R, Lofmark HB, Martinsson A, Melki D, Sarkar N, Svensson P, Jernberg T. A Rule-Out Strategy Based on High-Sensitivity Troponin and HEART Score Reduces Hospital Admissions. Ann Emerg Med. 2019 May;73(5):491-499. doi: 10.1016/j.annemergmed.2018.11.039. Epub 2019 Jan 17.
- Background: PubMed 30571361Shen C, Ge J. Epidemic of Cardiovascular Disease in China: Current Perspective and Prospects for the Future. Circulation. 2018 Jul 24;138(4):342-344. doi: 10.1161/CIRCULATIONAHA.118.033484. No abstract available.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary computed tomographic angiography with CT - derived fractional flow reserve in people with Chest Pain and Coronary Artery Disease, run by Qilu Hospital of Shandong University 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 4 inclusion and 11 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: opening soon, as of the sponsor's last update on 20 Mar 2026. 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?
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 Chuanbao Li (+86 18560083097, bao2460@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Major adverse cardiovascular and cerebrovascular events (MACCE), defined as the composite endpoint of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and unstable angina pectoris (time frame: The enrollment phase will last for 2 years, and follow-up for all participants will continue until 12 months after the last participant is enrolled.). 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 NCT07140419, which also lists 10 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 20 Mar 2026.