Coronary Computed Tomographic Angiography Combined With CT-FFR in Intermediate-Risk Chest Pain Patients.
Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Aug 18, 2025
Trial Information
Current as of September 09, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new way to help doctors diagnose and treat people who come to the emergency room with chest pain and are considered at moderate risk for heart problems. The study looks at using a special type of heart scan called coronary CTA, combined with a computer test called CT-FFR, to see if this approach can better guide treatment decisions and improve patient outcomes compared to the usual care. The goal is to find out if using this technology early on can help prevent serious heart events like heart attacks.
People who might be eligible for this study are adults (18 years or older) who come to the emergency department within 24 hours of having chest pain or symptoms that might be related to heart disease, and who have a moderate risk score based on a standard tool called the HEART score. Participants will need to give written consent to join. The study does not include people with very severe heart problems, those who have had certain heart surgeries before, or those with serious kidney or liver issues, among other exclusions. If you take part, you can expect to have this special heart scan to help doctors decide on the best treatment plan, and your health will be monitored to see how well this approach works in preventing major heart problems.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Age≥18 years;
- • 2. Within 24 hours of presenting to the emergency department (ED) with chest pain or other symptoms suggestive of coronary artery disease (CAD);
- • 3. HEART-score \>3 (according to http://www.heartscore.nl/);
- • 4. Signed written informed consent.
- Exclusion Criteria:
- • 1. Inability to obtain informed consent;
- • 2. Acute Coronary Syndromes (ACS) requiring urgent revascularization;
- • 3. Known Obstructive Coronary Artery Disease (CAD) or previous PCI or CABG;
- • 4. Concomitant severe congestive heart failure (New York Heart Association \[NYHA\] class III-IV or left ventricular ejection fraction \[LVEF\] \< 30%) or acute pulmonary edema;
- • 5. 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;
- • 6. History of prior coronary artery bypass grafting (CABG);
- • 7. Severe allergy to iodinated contrast agents;
- • 8. Inability to obtain high-quality imaging;
- • 9. Pregnant or lactating females;
- • 10. Concomitant diseases or limited life expectancy, quality of life, or functional status precluding further CAD evaluation;
- • 11. Any other factors that, in the investigator's judgment, make the patient unsuitable for study enrollment, completion of the study, or follow-up.
About Qilu Hospital Of Shandong University
Qilu Hospital of Shandong University is a leading medical institution dedicated to advancing healthcare through innovative clinical research and patient-centered care. Affiliated with Shandong University, the hospital integrates clinical practice with education and research, fostering an environment that promotes scientific discovery and the development of new therapies. With a commitment to high standards of clinical excellence and ethical research practices, Qilu Hospital plays a pivotal role in enhancing patient outcomes and contributing to the global medical community through a diverse range of clinical trials and studies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Jinan, Shandong, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported