FAPI Imaging Predicts Adverse Cardiac Events in Chronic Total Occlusion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLin Zhao
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
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).
Willingness to undergo FAPI-PET imaging and receive PCI under imaging guidance.
Ability to provide written informed consent.
Disqualifiers
Contraindications to antiplatelet therapy: Allergy or intolerance to aspirin, clopidogrel, or ticagrelor.
Severe liver dysfunction: Liver function parameters exceeding 3× the upper limit of normal.
Severe chronic kidney disease: Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m².
Life expectancy <1 year due to non-cardiovascular comorbidities.
Trial population
Patients presenting with at least one coronary chronic total occlusion (CTO) on coronary angiogram who will be treated by percutaneous coronary intervention
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
FAPl lmaging
Diagnostic testStudies have shown that imaging with radionuclide-labeled fibroblast activation protein inhibitor (FAPl) is a reliable technique for detecting myocardial fibrosis and activated CFs in arteries. Preliminary evidence suggests that FAPl imaging can assess plaque characteristics and the status of myocardial fibrosis in various cardiovascular diseases.
Treatment groups
470 Participants
are divided into 1 treatment groupGroup A: Patients with at least one untreated CTOat basal angiography1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Major Adverse Cardiovascular Events (MACE)
MACE is defined as a composite of cardiac death, myocardial infarction, stroke, and urgent revascularization (including in-stent restenosis, target lesion revascularization, or target vessel revascularization). Events will be assessed through clinical follow-up and hospital record review.
Time frame
12 months after percutaneous coronary intervention (PCI)Secondary outcomes
1
All-Cause Mortality
Death from any cause, including cardiovascular and non-cardiovascular causes, occurring within 12 months after the index PCI procedure.
Time frame
12 months post-PCI, verified through national death registry and hospital records.2
Change in Quality of Life
Assessed using the Seattle Angina Questionnaire (SAQ). Outcome domains include angina frequency, physical limitation, and treatment satisfaction. Comparison is made between baseline and 12-month follow-up.
Time frame
At baseline and 12 months post-PCI.3
Repeat Percutaneous Coronary Intervention (Repeat PCI)
Incidence of repeat PCI due to recurrent or new coronary lesions within 12 months, categorized as: In-Stent Restenosis (ISR): ≥50% luminal narrowing in the original stented segment, with or without symptoms. Target Lesion Revascularization (TLR): Reintervention at the original stent site due to restenosis or thrombosis. Target Vessel Revascularization (TVR): Intervention in the same coronary artery, but outside the original stent site. De Novo Lesion: New lesion in a vessel not treated during the index PCI. Confirmation based on follow-up angiography.
Time frame
Within 12 months following the index PCI procedure.Angiographic confirmationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lin Zhao
Lead sponsor
Beijing Chao Yang Hospital
Sponsor institution
Source ClinicalTrials.gov