FAPI Imaging Predicts Adverse Cardiac Events in Chronic Total Occlusion
Prospective, observational, single-center cohort study Hypothesis Higher myocardial FAPI uptake in CTO patients predicts a greater incidence of major adverse cardiovascular events (MACE) within 12 months after PCI. FAPI PET/CT imaging is associated with plaque vulnerability features and may serve as a non-invasive mark
| Condition(s) | Chronic Total Occlusion (CTO), Chronic Coronary Syndrome |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Prospective, observational, single-center cohort study Hypothesis Higher myocardial FAPI uptake in CTO patients predicts a greater incidence of major adverse cardiovascular events (MACE) within 12 months after PCI. FAPI PET/CT imaging is associated with plaque vulnerability features and may serve as a non-invasive marker for fibrotic activity and adverse cardiac remodeling. Inclusion Criteria * Age ≥ 18 years * Presence of at least one untreated chronic total occlusion (CTO) lesion in a major coronary artery (diameter ≥ 2.5 mm, TIMI 0 flow for ≥ 3 months) confirmed by coronary angiography or CTCA * Patient eligible for PCI and undergoing FAPI PET/CT imaging prior to intervention * Written informed consent provided Exclusion Criteria * Allergy or contraindication to antiplatelet agents (asp |
| Who can participate | Inclusion Criteria: 1. Age ≥18 years. 2. Confirmed diagnosis of ≥1 untreated chronic total occlusion (CTO):Defined as complete occlusion of a major coronary artery or relevant collateral (reference vessel diameter ≥2.5 mm or confirmed by two independent interventional cardiologists), with TIMI flow grade 0 in the distal segment and duration ≥3 months.Preoperatively confirmed by coronary angiography or coronary computed tomography angiography (CTCA). 3. Willingness to undergo FAPI-PET imaging and receive PCI under imaging guidance. 4. Ability to provide written informed consent. Exclusion Criteria: 1. Contraindications to antiplatelet therapy: Allergy or intolerance to aspirin, clopidogrel, or ticagrelor. 2. Severe liver dysfunction: Liver function parameters exceeding 3× the upper limit of |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Lin Zhao |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2025-04-15 |
| NCT ID | NCT07020858 |
| Official listing | https://clinicaltrials.gov/study/NCT07020858 |