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FAPI Imaging Predicts Adverse Cardiac Events in Chronic Total Occlusion

NCT07020858 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 470

Last updated 2025-06-19

No results posted yet for this study

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.

Conditions

  • Chronic Total Occlusion (CTO)
  • Chronic Coronary Syndrome

Interventions

DIAGNOSTIC_TEST

FAPl lmaging

Studies 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.

Sponsors & Collaborators

  • Lin Zhao

    lead OTHER

Principal Investigators

  • Lin Zhao, Dr · Beijing Chaoyang Hospital, Capital Medical University, Beijing, China

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-15
Primary Completion
2026-03-15
Completion
2027-03-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07020858 on ClinicalTrials.gov