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.
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.
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;
Parallel
Coronary computed tomographic angiography with CT - derived fractional flow reserve
Diagnostic testA 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).
Incidence of Recurrent Emergency Department Visit for Chest Pain
Re-presentation with chest pain as the main complaint
Hospitalization Rate due to Chest Pain or Stroke
Incidence of All-cause mortality
All-cause mortality (cardiovascular death, non-cardiovascular death, death of undetermined cause)
Proportion of Patients Undergoing Invasive Coronary Angiography
Number of Participants with Allergic Reactions or Anaphylaxis within 24 Hours Post-CCTA or Invasive Coronary Angiography
Safety Outcome Measure
Number of Participants with Acute Liver or Kidney Injury within 7 Days Post-CCTA or Invasive Coronary Angiography
Safety Outcome Measure
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Qilu Hospital of Shandong University
Lead sponsor
The Affiliated Hospital of Qingdao University
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
Beijing Anzhen Hospital
Collaborator
JiNing NO.1 People Hospital
Collaborator
Zhun Ge Er Qi Central Hospital
Collaborator
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