An interventional study of Coronary computed tomographic angiography with CT - derived fractional flow reserve in Chest Pain, Coronary Artery Disease and Emergency Department, sponsored by Qilu Hospital of Shandong University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by Qilu Hospital of Shandong University · Not applicable, Interventional, and Diagnostic
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.
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.
381 studies on the registry are indexed under Chest Pain; 66 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 143 across 201 interventional studies indexed under Chest Pain.
Browse Chest Pain studies →Qilu Hospital of Shandong University is the lead sponsor of 299 studies on the registry; 181 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Diagnostic Test: Coronary computed tomographic angiography with CT - derived fractional flow reserve
Patients receive standard care without early CCTA, with further management determined at the discretion of their treating physician.
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.
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).
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.
Incidence of Recurrent Emergency Department Visit for Chest Pain
Re-presentation with chest pain as the main complaint
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
All-cause mortality (cardiovascular death, non-cardiovascular death, death of undetermined cause)
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
Utilization of preventive medications (antiplatelet agents, lipid-lowering therapies), including antiplatelet therapy, statins, and antihypertensive agents.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 Year and 5 Year
Number of Participants with Allergic Reactions or Anaphylaxis within 24 Hours Post-CCTA or Invasive Coronary Angiography
Safety Outcome Measure
Time frame: Within 24 hours of CCTA or invasive coronary angiography
Number of Participants with Acute Liver or Kidney Injury within 7 Days Post-CCTA or Invasive Coronary Angiography
Safety Outcome Measure
Time frame: Within 7 days of CCTA or invasive coronary angiography
Plan to share: No
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Qilu Hospital of Shandong University