Status:
NOT_YET_RECRUITING
Coronary Computed Tomographic Angiography Combined With CT-FFR in Intermediate-Risk Chest Pain Patients.
Lead Sponsor:
Qilu Hospital of Shandong University
Collaborating Sponsors:
The Affiliated Hospital of Qingdao University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Chest Pain
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 imp...
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), de...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2032
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT07140419
Start Date
September 20 2025
End Date
January 31 2032
Last Update
September 22 2025
Active Locations (1)
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1
Chuanbao Li
Jinan, Shandong, China, 250000