FAPI Imaging Assessment of Chronic Total Occlusion

NCT ID: NCT06655922

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 167 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-10
• Study Completion Date: 2026-08-31

Brief Summary

This registry will include consecutive patients presenting with at least one chronic total coronary occlusion (CTO) identified via coronary angiography or cardiac computed tomography angiography (CCTA) at our center. Due to the complexity of CTO lesions, both procedural success rates and prognosis improvements are limited. The progression and development of atherosclerotic plaques involve fibroblast activity, contributing to the formation of fibrous caps and calcified nodules through various mechanisms. Myocardial fibrosis within chronically occluded segments is strongly linked to ventricular remodeling and patient prognosis. The activation of cardiac fibroblasts (CFs) is a critical early phase in myocardial fibrosis, playing a key role in fibrotic progression. However, the role of activated CFs in CTO patients has remained unclear, mainly due to the lack of reliable in vivo assessment techniques for detecting CF activation.

Recent studies have demonstrated that radionuclide-labeled fibroblast activation protein inhibitor (FAPI) imaging is an effective and reliable technique for detecting both myocardial fibrosis and activated CFs in arterial plaques. Preliminary data suggest that FAPI imaging can characterize plaque composition and assess the extent of myocardial fibrosis in various cardiovascular conditions. However, its potential to predict the ease of CTO recanalization and subsequent clinical outcomes remains to be fully explored.

The aim of this prospective cohort study is to evaluate the predictive value of FAPI imaging in patients with at least one untreated CTO. All enrolled patients will undergo baseline assessments prior to intervention, including blood tests, clinical evaluations, and imaging studies. These imaging studies will include myocardial FDG/perfusion imaging, FAPI imaging, and resting perfusion imaging. In selected patients, additional evaluations such as stress myocardial perfusion imaging, magnetic resonance imaging (MRI), and echocardiography will also be performed.

For patients undergoing percutaneous coronary intervention (PCI), follow-up assessments will occur at 6 and 12 months. At the 6-month mark, improvements in left ventricular (LV) wall motion will be assessed using resting perfusion imaging. At 12 months, coronary angiography (CAG) will be performed on all patients to evaluate recanalization outcomes. Additionally, myocardial perfusion imaging, magnetic resonance imaging (MRI), and echocardiography may be selectively used to evaluate patients during the 12-month follow-up.

1. To evaluate the ability of FAPI imaging in predicting the difficulty of CTO recanalization.

2. To investigate the role of myocardial FAPI imaging in predicting the improvement of LV wall motion at 6 months, assessed using follow-up single-photon emission computed tomography (SPECT).

By comparing FAPI imaging with conventional prognostic assessment methods, this study aims to clarify the utility of FAPI imaging in both predicting the recanalization complexity and in assessing long-term clinical outcomes in CTO patients.

Conditions

Chronic Total Occlusion (CTO)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with at least one untreated CTO at basal angiography

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

FAPI Imaging

Intervention Type: DIAGNOSTIC_TEST

Studies have shown that imaging with radionuclide-labeled fibroblast activation protein inhibitor (FAPI) is a reliable technique for detecting myocardial fibrosis and activated CFs in arteries. Preliminary evidence suggests that FAPI imaging can assess plaque characteristics and the status of myocardial fibrosis in various cardiovascular diseases.

Interventions

FAPI Imaging

Studies have shown that imaging with radionuclide-labeled fibroblast activation protein inhibitor (FAPI) is a reliable technique for detecting myocardial fibrosis and activated CFs in arteries. Preliminary evidence suggests that FAPI imaging can assess plaque characteristics and the status of myocardial fibrosis in various cardiovascular diseases.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age > 18 years
• Presence of at least one untreated CTO at basal angiography (defined as a total occlusion in any major coronary vessel or relevant side branches [reference vessel diameter ≥2.5mm or as judged by two independent interventional cardiologists], with TIMI 0 in the distal segment and at least 3 months old
• Patient has a clinical indication to perform CTO PCI
• Willing to participate and able to understand, read and sign the informed consent document.

Exclusion Criteria

• Hypersensitivity to aspirin, clopidogrel, or -limus families / or contraindication to antiplatelet agents
• Severe hepatic dysfunction (≥3 times normal reference values)
• Severe chronic kidney disease (estimated Glomerular Filtration Rate [eGFR] <30 mL/min/1.73m2)
• Life expectancy < 1 years
• Pregnant women or women with potential childbearing

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Chao Yang Hospital

OTHER

Sponsor Role: collaborator

Lin Zhao

OTHER

Sponsor Role: lead

Responsible Party

Lin Zhao

Cheif of Cardiovascular department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lin Zhao, Ph.D MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Chaoyang Hospital, Capital Medical University, Beijing, China

Locations

Beijing Chaoyang Hospital, Capital Medical University, Beijing, China

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Beijing Chaoyang Hospital, Capital Medical University, Beijing, China

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shengwen Yang, Ph.D, MD

Role: CONTACT

verayang1990@163.com

+8617801014018 ext. +8601085231480

Bin Tu, Ph.D MD

Role: CONTACT

dr_bintu@163.com

+8618810682692 ext. +8601085231480

Facility Contacts

Shengwen Yang, Ph.D MD

Role: primary

verayang1990@163.com

+86-17801014018 ext. +8685231480

Shengwen Yang, Ph.D MD

Role: primary

verayang1990@163.com

+8601085231480

References

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.

Reference Type: BACKGROUND

PMID: 31433921 (View on PubMed)

Perera D, Clayton T, Petrie MC, Greenwood JP, O'Kane PD, Evans R, Sculpher M, Mcdonagh T, Gershlick A, de Belder M, Redwood S, Carr-White G, Marber M; REVIVED investigators. Percutaneous Revascularization for Ischemic Ventricular Dysfunction: Rationale and Design of the REVIVED-BCIS2 Trial: Percutaneous Coronary Intervention for Ischemic Cardiomyopathy. JACC Heart Fail. 2018 Jun;6(6):517-526. doi: 10.1016/j.jchf.2018.01.024.

Reference Type: BACKGROUND

PMID: 29852933 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36219116 (View on PubMed)

Other Identifiers

2024-772-1

Identifier Type: -

Identifier Source: org_study_id