FAPI Imaging Predicts Adverse Cardiac Events in Chronic Total Occlusion

NCT07020858 | Recruiting DMC

• 1 other identifier: 2025-ke-415
• Study Type: observational
• Target: 470
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Total Occlusion (CTO); Chronic Coronary Syndrome

Keywords

Coronary Heart Disease; Major adverse cardiovascular events (MACE); Plaque vulnerability; Optical coherence tomography (OCT); Fibroblast activation protein inhibitor (FAPI); Percutaneous coronary intervention (PCI)

Outcome Measures

Primary Outcomes (1)

• Incidence of Major Adverse Cardiovascular Events (MACE)

  MACE is defined as a composite of cardiac death, myocardial infarction, stroke, and urgent revascularization (including in-stent restenosis, target lesion revascularization, or target vessel revascularization). Events will be assessed through clinical follow-up and hospital record review.

  12 months after percutaneous coronary intervention (PCI)

Secondary Outcomes (3)

• All-Cause Mortality

  12 months post-PCI, verified through national death registry and hospital records.

• Change in Quality of Life

  At baseline and 12 months post-PCI.

• Repeat Percutaneous Coronary Intervention (Repeat PCI)

  Within 12 months following the index PCI procedure.Angiographic confirmation

Study Arms (1)

Patients with at least one untreated CTOat basal angiography

Total occlusion in any major coronary vessel or relevant side branches \[reference vessel diameter \>2.5 mm or as judged by two independent interventional cardiologists\], with TIMI 0 in the distal segment and at least 3 months old

Diagnostic Test: FAPl lmaging

Interventions

FAPl lmaging DIAGNOSTIC_TEST

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.

Patients with at least one untreated CTOat basal angiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting with at least one coronary chronic total occlusion (CTO) on coronary angiogram who will be treated by percutaneous coronary intervention

You may qualify if:

• Age ≥18 years.
• 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).
• Willingness to undergo FAPI-PET imaging and receive PCI under imaging guidance.
• Ability to provide written informed consent.

You may not qualify if:

• Contraindications to antiplatelet therapy: Allergy or intolerance to aspirin, clopidogrel, or ticagrelor.
• Severe liver dysfunction: Liver function parameters exceeding 3× the upper limit of normal.
• Severe chronic kidney disease: Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m².
• Life expectancy \<1 year due to non-cardiovascular comorbidities.
• Pregnancy or women of childbearing potential (unless surgically sterile or using contraception).

Sponsors & Collaborators

• Lin Zhao: lead

Study Sites (1)

Beijing Chaoyang Hospital，Capital Medical University，Beijing，China

Beijing, Beijing Municipality, 100020, China

RECRUITING

Related Publications (3)

• Park TK, Lee SH, Choi KH, Lee JM, Yang JH, Song YB, Hahn JY, Choi JH, Gwon HC, Lee SH, Choi SH. Late Survival Benefit of Percutaneous Coronary Intervention Compared With Medical Therapy in Patients With Coronary Chronic Total Occlusion: A 10-Year Follow-Up Study. J Am Heart Assoc. 2021 Mar 16;10(6):e019022. doi: 10.1161/JAHA.120.019022. Epub 2021 Mar 4.

  PMID: 33660515 BACKGROUND

• Werner GS, Hildick-Smith D, Martin Yuste V, Boudou N, Sianos G, Gelev V, Rumoroso JR, Erglis A, Christiansen EH, Escaned J, Di Mario C, Teruel L, Bufe A, Lauer B, Galassi AR, Louvard Y. Three-year outcomes of A Randomized Multicentre Trial Comparing Revascularization and Optimal Medical Therapy for Chronic Total Coronary Occlusions (EuroCTO). EuroIntervention. 2023 Sep 18;19(7):571-579. doi: 10.4244/EIJ-D-23-00312.

  PMID: 37482940 BACKGROUND

• Yang L, Guo L, Lv H, Liu X, Zhong L, Ding H, Zhou X, Zhu H, Huang R. Predictors of Adverse Events Among Chronic Total Occlusion Patients Undergoing Successful Percutaneous Coronary Intervention and Medical Therapy. Clin Interv Aging. 2021 Oct 14;16:1847-1855. doi: 10.2147/CIA.S337069. eCollection 2021.

  PMID: 34703218 BACKGROUND

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Lin Zhao, Dr

  Beijing Chaoyang Hospital, Capital Medical University, Beijing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shengwen Yang, Dr

CONTACT

+8601085231480; verayang1990@163.com

Bin Tu

CONTACT

+8601085231480; dr_bintu@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cheif of Cardiovascular department

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 13, 2025
• Study Start: April 15, 2025
• Primary Completion: March 15, 2026
• Study Completion (Estimated): March 15, 2027
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Access Criteria: Need a proposal that describes planned analyses and a data sharing agreement.

Locations

CN (1)