FAPI PET/CT to predict adverse cardiac events after PCI for chronic total occlusion

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

This will test whether FAPI PET/CT scans done before PCI can help predict major heart problems within 12 months in adults with chronic total coronary occlusion.

Quick facts

• Study type: Observational
• Enrollment: 470 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Chao Yang Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07020858 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-center observational cohort of adults with at least one untreated chronic total occlusion who undergo baseline 18F-FAPI PET/CT prior to PCI and are followed for 12 months. The study will measure myocardial and plaque FAPI uptake and relate uptake levels to the incidence of major adverse cardiovascular events (MACE) after PCI. Where available, imaging features of plaque vulnerability (including OCT findings) and measures of adverse remodeling will be compared with FAPI signals. The goal is to determine whether noninvasive FAPI imaging provides prognostic information beyond standard clinical and angiographic data.

Who should consider this trial

Good fit: Adults aged 18 or older with at least one untreated CTO (reference vessel ≥2.5 mm, TIMI 0 for ≥3 months) who are eligible for PCI, willing to undergo preprocedural FAPI PET/CT, and can provide informed consent.

Not a fit: Patients with contraindications to antiplatelet therapy, severe liver dysfunction, advanced renal failure (eGFR <30), limited life expectancy (<1 year), or pregnancy are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, FAPI PET/CT could identify CTO patients at higher risk of adverse events after PCI so clinicians can tailor follow-up and management.

How similar studies have performed: Preliminary data (the original FACT study) showed FAPI imaging may predict ventricular remodeling at 6 months, but long-term prognostic value and plaque-vulnerability correlations remain incompletely established.

Eligibility criteria

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 normal.
3. Severe chronic kidney disease: Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m².
4. Life expectancy \<1 year due to non-cardiovascular comorbidities.
5. Pregnancy or women of childbearing potential (unless surgically sterile or using contraception).

Where this trial is running

Beijing, Beijing Municipality

• Beijing Chaoyang Hospital，Capital Medical University，Beijing，China — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Lin Zhao, Dr — Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
• Study coordinator: Shengwen Yang, Dr

Conditions Chronic Total Occlusion; Chronic Coronary Syndrome; Coronary Heart Disease; Major adverse cardiovascular events; Plaque vulnerability; Optical coherence tomography; Fibroblast activation protein inhibitor; Percutaneous coronary intervention