Imaging assessment of chronic total coronary occlusion
The Clinical Value of FAPI Imaging in Assessing Chronic Total Occlusion Lesions in Patients with Coronary Heart Disease (FACT Trial)
Beijing Chao Yang Hospital · NCT06655922
This study looks at how a special imaging technique can help understand heart tissue changes in patients with blocked arteries to see if it can improve their treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 167 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Chao Yang Hospital (other) |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT06655922 on ClinicalTrials.gov |
What this trial studies
This observational registry includes patients with at least one chronic total coronary occlusion (CTO) identified through coronary angiography or cardiac computed tomography angiography. The study aims to evaluate the role of fibroblast activation in the progression of myocardial fibrosis and its impact on patient prognosis. By utilizing FAPI imaging, the study seeks to provide insights into the activation of cardiac fibroblasts in CTO patients, which has been challenging to assess reliably in vivo. The findings may help improve procedural success rates and patient outcomes in those undergoing percutaneous coronary intervention (PCI) for CTO.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with at least one untreated chronic total coronary occlusion requiring PCI.
Not a fit: Patients with severe hepatic dysfunction, severe chronic kidney disease, or life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of myocardial fibrosis in CTO patients and improve treatment strategies, leading to better patient outcomes.
How similar studies have performed: Other studies have shown promise in using imaging techniques to assess fibroblast activity, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * Presence of at least one untreated CTO at basal angiography (defined as a total occlusion in any major coronary vessel or relevant side branches \[reference vessel diameter ≥2.5mm or as judged by two independent interventional cardiologists\], with TIMI 0 in the distal segment and at least 3 months old * Patient has a clinical indication to perform CTO PCI * Willing to participate and able to understand, read and sign the informed consent document. Exclusion Criteria: * Hypersensitivity to aspirin, clopidogrel, or -limus families / or contraindication to antiplatelet agents * Severe hepatic dysfunction (≥3 times normal reference values) * Severe chronic kidney disease (estimated Glomerular Filtration Rate \[eGFR\] \<30 mL/min/1.73m2) * Life expectancy \< 1 years * Pregnant women or women with potential childbearing
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Beijing Chaoyang Hospital, Capital Medical University, Beijing, China — Beijing, Beijing Municipality, China (RECRUITING)
- Beijing Chaoyang Hospital, Capital Medical University, Beijing, China — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Principal investigator: Lin Zhao, Ph.D MD — Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
- Study coordinator: Shengwen Yang, Ph.D, MD
- Email: verayang1990@163.com
- Phone: +8617801014018
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Total Occlusion, Coronary Heart Disease, Fibroblast activation protein inhibitor, Percutaneous coronary intervention, Imaging, Prognosis