Actively Recruiting

Age: 18Years +
All Genders
NCT07020858

FAPI Imaging Predicts Adverse Cardiac Events in Chronic Total Occlusion

Led by Lin Zhao · Updated on 2025-06-19

470

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

FAPI Imaging Predicts Adverse Cardiac Events in Chronic Total Occlusion

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Presence of at least one untreated chronic total occlusion (CTO) in a major coronary artery with diameter 2.5 mm or more and TIMI 0 flow for at least 3 months confirmed by coronary angiography or CTCA
  • Eligible for PCI and willing to undergo FAPI PET/CT imaging before intervention
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Allergy or intolerance to antiplatelet drugs such as aspirin, clopidogrel, or ticagrelor
  • Severe liver dysfunction with liver enzymes more than 3 times the upper limit of normal
  • Severe chronic kidney disease with estimated glomerular filtration rate below 30 mL/min/1.73 m²
  • Life expectancy less than 1 year due to other medical conditions
  • Pregnancy or women of childbearing potential unless surgically sterile or using contraception

AI-Screening

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Trial Site Locations

Total: 1 location

1

Beijing Chaoyang Hospital,Capital Medical University,Beijing,China

Beijing, Beijing Municipality, China, 100020

Actively Recruiting

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Research Team

S

Shengwen Yang, Dr

CONTACT

B

Bin Tu

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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FAPI Imaging Predicts Adverse Cardiac Events in Chronic Total Occlusion | DecenTrialz