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A prospective, multicenter, randomized controlled clinical trial on the impact of coronary artery CTA combined with CT-FFR on the diagnostic and treatment decisions and clinical outcomes of emergency moderate-risk chest pain patients.

A prospective, multicenter, randomized controlled clinical trial on the impact of coronary artery CTA combined with CT-FFR on the diagnostic and treatment decisions and clinical outcomes of emergency moderate-risk chest pain patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109188
Enrollment
Unknown
Registered
2025-09-15
Start date
2025-09-15
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute chest pain in emergency

Interventions

Intervention group:Patients receive early coronary computed tomographic angiography (CCTA) combined with CT-derived fractional flow reserve (CT-FFR) to guide diagnostic and treatment decisions, in add
Control Group:Patients receive standard care without early CCTA, with further management determined at the discretion of their treating physician.

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.18 years old and above; 2. Within 24 hours after visiting the emergency department due to chest pain or other symptoms of coronary heart disease (CAD); 3. The HEART score > 3 (according to http://www.heartscore.nl/); 4. Sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Unable to obtain informed consent form; 2. Patients with acute coronary syndrome who require urgent revascularization; 3. Known obstructive CAD (stenosis >= 50%, previous PCI or CABG); 4. Complicated with severe congestive heart failure (NYHA grade III-IV or LVEF =C, or AST> 5 times the upper limit); Patients with severe renal insufficiency (estimated glomerular filtration rate <=30mL/min / 1.73 m^2) or those receiving continuous renal replacement therapy, hemodialysis, or peritoneal dialysis; 6. The patient has a previous history of Coronary Artery Bypass Grafting (CABG); 7. Severe allergy to iodine contrast agent; 8. Situations where high-quality images cannot be obtained; 9. Pregnant and lactating female patients; 10. Combined with other diseases or with limited life expectancy, quality of life or functional status, further CAD examination cannot be conducted; 11. There are any factors that other researchers consider unsuitable for inclusion in this study or completion of the study and follow-up.

Design outcomes

Primary

MeasureTime frame
Major adverse cardiovascular events (MACE), defined as the composite endpoint of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and unstable angina pectoris.;

Secondary

MeasureTime frame
Short-term hospitalization rate;All-cause mortality (cardiovascular death, non-cardiovascular death, death of undetermined cause);Cardiovascular Death;Nonfatal Myocardial Infarction;Nonfatal Stroke;Recurrent Emergency Department Visit for Chest Pain;Proportion of Patients Undergoing Invasive Coronary Angiography;Proportion of Patients with Non-Obstructive CAD at Invasive Coronary Angiography;Effect of an Early CCTA with CT-FFR Diagnostic Strategy on Preventive Medication Utilization in Intermediate-Risk Emergency Department Chest Pain Patients;Total Direct Medical Costs per Participant [Cumulative direct medical costs including emergency department care, diagnostic testing, preventive/therapeutic medications, invasive procedures, and hospitalizations related to cardiovascular events. Costs will be standardized to 2025 Chinese Yuan using national health service price indices];

Countries

China

Contacts

Public ContactChen Yuguo

Qilu Hospital of Shandong University

chen919085@sdu.edu.cn+86 185 6008 5555

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026