Actively Recruiting
FAPI Imaging Predicts Adverse Cardiac Events in Chronic Total Occlusion
Led by Lin Zhao · Updated on 2025-06-19
470
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 (aspirin, clopidogrel, or ticagrelor) * Severe liver dysfunction (liver enzymes \>3× upper limit of normal) * Severe chronic kidney disease (eGFR \< 30 mL/min/1.73 m²) * Estimated life expectancy \< 1 year * Pregnancy or potential for pregnancy Primary Endpoint Incidence of 1-year MACE, defined as a composite of: Cardiac death, Myocardial infarction, Stroke, Urgent revascularization Secondary Endpoints * All-Cause Mortality * Death from any cause within 12 months * Quality of Life Change: Measured by Seattle Angina Questionnaire (SAQ): changes in angina frequency, physical limitation, and treatment satisfaction * Repeat PCI Events: Incidence of: In-stent restenosis (ISR): ≥50% luminal loss in previously stented segment; Target lesion revascularization (TLR): at original PCI lesion; Target vessel revascularization (TVR): other sites in same vessel; De novo lesions: new lesions not previously treated Sample Size Estimated 470 patients Follow-Up Duration 12 months post-PCI, One follow-up visit including clinical exam, SAQ questionnaire, imaging (PET/CT, echocardiography), and laboratory testing.
CONDITIONS
Official Title
FAPI Imaging Predicts Adverse Cardiac Events in Chronic Total Occlusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Presence of at least one untreated chronic total occlusion (CTO) in a major coronary artery with diameter 2.5 mm or more and TIMI 0 flow for at least 3 months confirmed by coronary angiography or CTCA
- Eligible for PCI and willing to undergo FAPI PET/CT imaging before intervention
- Able to provide written informed consent
You will not qualify if you...
- Allergy or intolerance to antiplatelet drugs such as aspirin, clopidogrel, or ticagrelor
- Severe liver dysfunction with liver enzymes more than 3 times the upper limit of normal
- Severe chronic kidney disease with estimated glomerular filtration rate below 30 mL/min/1.73 m²
- Life expectancy less than 1 year due to other medical conditions
- Pregnancy or women of childbearing potential unless surgically sterile or using contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Chaoyang Hospital,Capital Medical University,Beijing,China
Beijing, Beijing Municipality, China, 100020
Actively Recruiting
Research Team
S
Shengwen Yang, Dr
CONTACT
B
Bin Tu
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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