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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: verayang1990@163.com
• Phone: +8601085231480

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.