FAPl Imaging Assessment of Revascularization Outcome in Ischemic Heart Failure

NCT07657650 | Recruiting DMC

• 1 other identifier: CFH2026-2-2032
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Heart Failure

Keywords

Ischemic heart failure; Revascularization; Fibroblast activation; Molecular imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The occurrence of major adverse cardiovascular events (MACE) within 12 months after the surgery

  From the time of enrollment until 12 months after the surgery

Study Arms (1)

IHF patients who are scheduled to receive revascularization treatment

This cohort consists of patients with IHF who are scheduled to undergo revascularization therapy. All participants will have a confirmed diagnosis of IHF with LVEF ≤ 40%. Participants will be consecutively enrolled from Beijing Chaoyang Hospital, Capital Medical University. This is an observational cohort study; no intervention is assigned. All participants will receive standard revascularization treatment (percutaneous coronary intervention or coronary artery bypass grafting) as determined by their treating physicians according to current clinical guidelines. Pre-revascularization assessments include ¹⁸F-FAPI PET/CT, ¹⁸F-FDG PET/CT, and ⁹⁹ᵐTc-MIBI SPECT imaging, along with comprehensive clinical and laboratory evaluations. Participants will be followed up at 12 months post-revascularization to assess changes in LVEF and the occurrence of major adverse cardiovascular events.

Procedure: PCI (ercutaneous coronary intervention) and CABG (coronary artery bypass grafting, commonly known as heart bypass surgery)

Interventions

PCI (ercutaneous coronary intervention) and CABG (coronary artery bypass grafting, commonly known as heart bypass surgery) PROCEDURE

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.

IHF patients who are scheduled to receive revascularization treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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%.

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing Chaoyang Hospital, Capital Medical University

Beijing, 100020, China

RECRUITING

Related Publications (10)

• Su Y, Liu X, Fu N, Dou L, Zhang Q, Zhao J, Yang Q, Lu C, Yang MF. Myocardial fibroblast activation imaging in prediction of cardiac functional improvement of non-ischemic heart failure. Int J Cardiol Heart Vasc. 2025 Jul 20;60:101752. doi: 10.1016/j.ijcha.2025.101752. eCollection 2025 Oct.

  PMID: 41050875 BACKGROUND

• Wang X, Shen K, Zhang Y, Gao Y, Liu B, Guo Y, Ren C, Huang Z, Li X, Chang L, Ding H, Zhang H, Tian Z, Hacker M, Zhang S, Wang Y, Li J, Li X, Huo L. Molecular Stratification of Light-Chain Cardiac Amyloidosis With 18F-Florbetapir and 68Ga-FAPI-04 for Enhanced Prognostic Precision. JACC Cardiovasc Imaging. 2025 Mar;18(3):323-336. doi: 10.1016/j.jcmg.2024.10.001. Epub 2025 Jan 8.

  PMID: 39797876 BACKGROUND

• Moura B, Aimo A, Al-Mohammad A, Keramida K, Ben Gal T, Dorbala S, Todiere G, Cameli M, Barison A, Bayes-Genis A, von Bardeleben RS, Bucciarelli-Ducci C, Delgado V, Mordi IR, Seferovic P, Savarese G, Celutkiene J, Rapezzi C, Emdin M, Coats A, Metra M, Rosano G. Diagnosis and management of patients with left ventricular hypertrophy: Role of multimodality cardiac imaging. A scientific statement of the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2023 Sep;25(9):1493-1506. doi: 10.1002/ejhf.2997. Epub 2023 Sep 4.

  PMID: 37581253 BACKGROUND

• Beanlands RS, Nichol G, Huszti E, Humen D, Racine N, Freeman M, Gulenchyn KY, Garrard L, deKemp R, Guo A, Ruddy TD, Benard F, Lamy A, Iwanochko RM; PARR-2 Investigators. F-18-fluorodeoxyglucose positron emission tomography imaging-assisted management of patients with severe left ventricular dysfunction and suspected coronary disease: a randomized, controlled trial (PARR-2). J Am Coll Cardiol. 2007 Nov 13;50(20):2002-12. doi: 10.1016/j.jacc.2007.09.006. Epub 2007 Oct 10.

  PMID: 17996568 BACKGROUND

• Barton AK, Craig NJ, Loganath K, Joshi S, Tsampasian V, Mahendran M, Lenell J, Tzolos E, Singh T, Whittington B, Nash J, Williams MC, van Beek EJR, MacAskill MG, Berkeley B, Vezaides S, Brittan M, Baker AH, Sellers S, Fletcher A, Clark T, Waight C, Slart RHJA, Berman D, Dey D, Slomka P, Newby DE, Dweck MR. Myocardial Fibroblast Activation After Acute Myocardial Infarction: A Positron Emission Tomography and Magnetic Resonance Study. J Am Coll Cardiol. 2025 Feb 18;85(6):578-591. doi: 10.1016/j.jacc.2024.10.103. Epub 2025 Jan 8.

  PMID: 39772364 BACKGROUND

• Zhang Y, Dong Z, Wang L, Wang YL, Chen BX, Su Y, Zhao S, Yang MF. Functional significance of myocardial activity at 18F-FAPI PET/CT in hypertrophic cardiomyopathy identified by cardiac magnetic resonance feature-tracking strain analysis. Eur J Nucl Med Mol Imaging. 2023 Dec;51(1):110-122. doi: 10.1007/s00259-023-06411-0. Epub 2023 Aug 29.

  PMID: 37642705 BACKGROUND

• Wang L, Wang Y, Wang J, Xiao M, Xi XY, Chen BX, Su Y, Zhang Y, Xie B, Dong Z, Zhao S, Yang MF. Myocardial Activity at 18F-FAPI PET/CT and Risk for Sudden Cardiac Death in Hypertrophic Cardiomyopathy. Radiology. 2023 Feb;306(2):e221052. doi: 10.1148/radiol.221052. Epub 2022 Oct 11.

  PMID: 36219116 BACKGROUND

• Panza JA, Ellis AM, Al-Khalidi HR, Holly TA, Berman DS, Oh JK, Pohost GM, Sopko G, Chrzanowski L, Mark DB, Kukulski T, Favaloro LE, Maurer G, Farsky PS, Tan RS, Asch FM, Velazquez EJ, Rouleau JL, Lee KL, Bonow RO. Myocardial Viability and Long-Term Outcomes in Ischemic Cardiomyopathy. N Engl J Med. 2019 Aug 22;381(8):739-748. doi: 10.1056/NEJMoa1807365.

  PMID: 31433921 BACKGROUND

• Velazquez EJ, Lee KL, Deja MA, Jain A, Sopko G, Marchenko A, Ali IS, Pohost G, Gradinac S, Abraham WT, Yii M, Prabhakaran D, Szwed H, Ferrazzi P, Petrie MC, O'Connor CM, Panchavinnin P, She L, Bonow RO, Rankin GR, Jones RH, Rouleau JL; STICH Investigators. Coronary-artery bypass surgery in patients with left ventricular dysfunction. N Engl J Med. 2011 Apr 28;364(17):1607-16. doi: 10.1056/NEJMoa1100356. Epub 2011 Apr 4.

  PMID: 21463150 BACKGROUND

• Harikrishnan S, Bahl A, Roy A, Mishra A, Prajapati J, Manjunath CN, Sethi R, Guha S, Satheesh S, Dhaliwal RS, Sharma M, Ganapathy S, Jeemon P. One-year mortality and re-admission rate by disease etiology in National Heart Failure Registry of India. Nat Commun. 2025 Jan 2;16(1):275. doi: 10.1038/s41467-024-55362-z.

  PMID: 39746979 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral venous blood samples will be collected from all participants at baseline (prior to revascularization) and during the 12-month follow-up visit. Serum and plasma will be separated by centrifugation and aliquoted for storage at -80°C. These biospecimens will be used for the measurement of cardiac injury biomarkers (N-terminal pro-B-type natriuretic peptide, creatine kinase, creatine kinase-MB, cardiac troponin I, and low-density lipoprotein), inflammatory markers (white blood cell count, monocyte count, and high-sensitivity C-reactive protein), as well as fibrosis-related and cytokine markers (peripheral blood fibroblast activation protein, tumor necrosis factor-alpha, transforming growth factor-beta 1, and interleukin-6). These specimens are intended for biomarker analysis only and will not be used for DNA extraction or genetic testing.

MeSH Terms

Interventions

Coronary Artery Bypass

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Central Study Contacts

Min-Fu Yang, MD

CONTACT

+86-10-85231356; minfuyang@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)