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The Value of FAPI Imaging for the Prediction of Adverse Cardiovascular Events in Chronic Total Occlusion of Coronary Artery Disease (FACT-2 Trial)

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
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 (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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Chaoyang Hospital,Capital Medical University,Beijing,China
RECRUITING
Beijing
Contact Information
Primary
Shengwen Yang, Dr
verayang1990@163.com
+8601085231480
Backup
Bin Tu
dr_bintu@163.com
+8601085231480
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2027-03-15
Participants
Target number of participants: 470
Treatments
Patients with at least one untreated CTOat basal angiography
Total occlusion in any major coronary vessel or relevant side branches \[reference vessel diameter \>2.5 mm or as judged by two independent interventional cardiologists\], with TIMI 0 in the distal segment and at least 3 months old
Sponsors
Leads: Lin Zhao

This content was sourced from clinicaltrials.gov