Chest Pain, Coronary Artery Disease, Emergency Department
Conditions
Keywords
Intermediate Risk Chest Pain, Emergency Department, CCTA, CT-FFR, Coronary Artery Disease
Brief 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. 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.
Interventions
DIAGNOSTIC_TESTCoronary computed tomographic angiography with CT - derived fractional flow reserve
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.
Sponsors
Qilu Hospital of Shandong University
The Affiliated Hospital of Qingdao University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Beijing Anzhen Hospital
JiNing NO.1 People Hospital
Zhun Ge Er Qi Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
Prior to outcome adjudication, all relevant documents will be de-identified to exclude any reference to prior coronary computed tomographic angiography (CCTA) results, ensuring evaluators remain blinded to baseline imaging data that could influence objective assessment.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age≥18 years； 2. Within 24 hours of presenting to the emergency department (ED) with chest pain or other symptoms suggestive of coronary artery disease (CAD)； 3. HEART-score \>3 (according to http://www.heartscore.nl/)； 4. Signed written informed consent.
Exclusion criteria
1. Inability to obtain informed consent； 2. Acute Coronary Syndromes (ACS) requiring urgent revascularization； 3. Known Obstructive Coronary Artery Disease (CAD) or previous PCI or CABG; 4. Concomitant severe congestive heart failure (New York Heart Association \[NYHA\] class III-IV or left ventricular ejection fraction \[LVEF\] \< 30%) or acute pulmonary edema; 5. 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; 6. History of prior coronary artery bypass grafting (CABG); 7. Severe allergy to iodinated contrast agents; 8. Inability to obtain high-quality imaging; 9. Pregnant or lactating females; 10. Concomitant diseases or limited life expectancy, quality of life, or functional status precluding further CAD evaluation; 11. Any other factors that, in the investigator's judgment, make the patient unsuitable for study enrollment, completion of the study, or follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Recurrent Emergency Department Visit for Chest Pain | 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 | Re-presentation with chest pain as the main complaint |
| Hospitalization Rate due to Chest Pain or Stroke | 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 | 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. | All-cause mortality (cardiovascular death, non-cardiovascular death, death of undetermined cause) |
| Proportion of Patients Undergoing Invasive Coronary Angiography | 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 | 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 | 1 Year, 2 Year, 3 Year, 4 Year, and 5 Year. | Utilization of preventive medications (antiplatelet agents, lipid-lowering therapies), including antiplatelet therapy, statins, and antihypertensive agents. |
| Health economic evaluation endpoints | 1 Year and 5 Year | 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. |
| Quality of Life Assessed by the Seattle Angina Questionnaire (SAQ) | 1 Year and 5 Year | 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. |
| Quality of Life Assessed by the EQ-5D Index Scores | 1 Year and 5 Year | 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. |
Countries
China
Contacts
CONTACTChuanbao Li
Outcome results
None listed