NCT07020858 FAPI Imaging Predicts Adverse Cardiac Events in Chronic Total Occlusion
| NCT ID | NCT07020858 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lin Zhao |
| Condition | Chronic Total Occlusion (CTO) |
| Study Type | OBSERVATIONAL |
| Enrollment | 470 participants |
| Start Date | 2025-04-15 |
| Primary Completion | 2026-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 470 participants in total. It began in 2025-04-15 with a primary completion date of 2026-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Contact & Investigator
Lin Zhao, Dr
PRINCIPAL INVESTIGATOR
Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
Frequently Asked Questions
Who can join the NCT07020858 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Total Occlusion (CTO). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07020858 currently recruiting?
Yes, NCT07020858 is actively recruiting participants. Contact the research team at verayang1990@163.com for enrollment information.
Where is the NCT07020858 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07020858 clinical trial?
NCT07020858 is sponsored by Lin Zhao. The principal investigator is Lin Zhao, Dr at Beijing Chaoyang Hospital, Capital Medical University, Beijing, China. The trial plans to enroll 470 participants.