Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Affiliated Hospital of Qingdao University | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
| Beijing Anzhen Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Arm | No Intervention | Patients receive standard care without early CCTA, with further management determined at the discretion of their treating physician. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary computed tomographic angiography with CT - derived fractional flow reserve | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Recurrent Emergency Department Visit for Chest Pain | Re-presentation with chest pain as the main complaint | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Allergic Reactions or Anaphylaxis within 24 Hours Post-CCTA or Invasive Coronary Angiography | Safety Outcome Measure | 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuanbao Li | Contact | +86 18560083097 | bao2460@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chuanbao Li | Jinan | Shandong | 250000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34709879 | Background | 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. | |
| 22830462 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| JiNing NO.1 People Hospital |
| UNKNOWN |
| Zhun Ge Er Qi Central Hospital | UNKNOWN |
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.
Not provided
Not provided
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.
|
| 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) | 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 | 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 | Utilization of preventive medications (antiplatelet agents, lipid-lowering therapies), including antiplatelet therapy, statins, and antihypertensive agents. | 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. | 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. | 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. | 1 Year and 5 Year |
Safety Outcome Measure |
| Within 7 days of CCTA or invasive coronary angiography |
| Background |
| Hoffmann 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. |
| 28855273 | Background | Gongora 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. |
| 28973101 | Background | Foy 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. |
| 30145934 | Background | SCOT-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. |
| 28446943 | Background | Moss 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. |
| 23331845 | Background | Goodacre 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. |
| 18462576 | Background | Mowatt 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. |
| 30661856 | Background | Ljung 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. |
| 30571361 | Background | Shen 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. |
| ID | Term |
|---|---|
| D002637 | Chest Pain |
| D003324 | Coronary Artery Disease |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
Not provided
Not provided