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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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);
- •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.
研究组 & 干预措施
Experimental Arm
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.
干预措施: Coronary computed tomographic angiography with CT - derived fractional flow reserve (Diagnostic Test)
Control Arm
Patients receive standard care without early CCTA, with further management determined at the discretion of their treating physician.
结局指标
主要结局
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
时间窗: 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).
次要结局
- 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)
- 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.)
- Health economic evaluation endpoints(1 Year and 5 Year)
- Quality of Life Assessed by the Seattle Angina Questionnaire (SAQ)(1 Year and 5 Year)
- 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.)
- 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)
- 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.)
- Quality of Life Assessed by the EQ-5D Index Scores(1 Year and 5 Year)
研究者
Chuanbao Li
Clinical Professor
Qilu Hospital of Shandong University