FAPl Imaging Assessment of Revascularization Outcome in Ischemic Heart Failure (FARO)

Ischemic heart failure (IHF) is the final stage of coronary heart disease. Coronary revascularization is an important treatment method for IHF, but it has high perioperative risks and not all patients can benefit from it. Evaluation of viable myocardium is one of the important decision-making methods for IHF, but recent research results have raised doubts about its value. The clinical community urgently needs more precise and comprehensive non-invasive decision-making methods. Fibroblast activation protein inhibitor (FAPI) imaging can specifically identify activated fibroblasts and achieve non-invasive diagnosis of the early and reversible stage of myocardial injury. Previous studies have shown that FAPI imaging can identify more damaged myocardium in various heart diseases compared to existing imaging techniques, demonstrating good clinical application potential. This study aims to conduct a prospective cohort trial for IHF patients who have undergone revascularization, using 18F-FAPI and viable myocardium (18F-FDG) imaging to analyze the degree of improvement in left ventricular ejection fraction after revascularization and major adverse cardiovascular events, and to explore the independent or additive predictive value of 18F-FAPI imaging, in order to provide a more reliable non-invasive imaging decision-making method for the revascularization strategy of IHF patients.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Heart Failure
• Intervention / Treatment: Procedure: PCI (ercutaneous coronary intervention) and CABG (coronary artery bypass grafting, commonly known as heart bypass surgery)

• Study Type: Observational
• Enrollment (Estimated): 122

Contacts and Locations

• Study Contact: Name: Min-Fu Yang, MD; Phone Number: +86-10-85231356; Email: minfuyang@126.com

Study Locations

• China
  • Beijing, China, 100020
    • Recruiting
    • Beijing Chaoyang Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

It meets the relevant standards for IHF as stipulated in the "2024 Chinese Guidelines for the Diagnosis and Treatment of Heart Failure", and has a clear history of ischemic heart disease (such as previous myocardial infarction, history of revascularization, or confirmed coronary artery lesions by coronary angiography), and the echocardiogram shows that LVEF is ≤ 40%.

Description

Inclusion Criteria:

① Age ≥ 18 years; ② Meet the above-mentioned IHF diagnostic criteria; ③ Coronary angiography shows suitability for revascularization (PCI or CABG); ④ NYHA cardiac function classification is II-IV; ⑤ Sign the informed consent form.

Exclusion Criteria:

① Heart failure caused by non-ischemic etiologies (such as dilated cardiomyopathy, valvular heart disease, myocarditis, etc.); ② Acute myocardial infarction occurred within the last 3 months; ③ Expected lifespan < 1 year; ④ Complicated with other severe systemic diseases; ⑤ Has a history of tumors; ⑥ Has any conditions that are unsuitable for revascularization (such as uncorrectable coagulation dysfunction, active bleeding, etc.)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IHF patients who are scheduled to receive revascularization treatment	Procedure: PCI (ercutaneous coronary intervention) and CABG (coronary artery bypass grafting, commonly known as heart bypass surgery); The intervention methods of PCI and CABG are the standard treatments prescribed by clinical doctors according to relevant guidelines. This study merely observes and records these treatments without influencing the clinical decisions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The absolute change in LVEF (ΔLVEF) from the baseline at 12 months after the surgery	From the time of enrollment until 12 months after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The occurrence of major adverse cardiovascular events (MACE) within 12 months after the surgery	Including the composite endpoint of cardiac death, recurrent non-fatal myocardial infarction, and readmission due to heart failure	From the time of enrollment until 12 months after the surgery

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 15, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Revascularization; Ischemic heart failure; Molecular imaging; Fibroblast activation
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Vascular Grafting; Myocardial Revascularization; Cardiac Surgical Procedures; Thoracic Surgical Procedures; Coronary Artery Bypass
• Other Study ID Numbers: CFH2026-2-2032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No