FAPI Imaging Assessment of Chronic Total Occlusion

NCT06655922 | Recruiting DMC

• 1 other identifier: 2024-772-1
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 2

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. 1.To evaluate the ability of FAPI imaging in predicting the difficulty of CTO recanalization.
2. 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).

Conditions

Chronic Total Occlusion (CTO)

Keywords

Coronary Heart Disease; Fibroblast activation protein inhibitor; Percutaneous coronary intervention; Imaging; Prognosis

Outcome Measures

Primary Outcomes (1)

• Improvement of left ventricular (LV) wall motion

  SPECT images (myocardial perfusion imaging, MPI) were analyzed using QPS/QGS software. Segmental wall motion was semi-quantitatively scored using the American Heart Association (AHA) 17-segment LV model and a five-point scale. 0=normal, 1=mildly hypokinetic, 2=moderately hypokinetic, 3=severely hypokinetic, 4=akinetic, 5=dyskinetic. The improvement of LV wall motion was defined as a decrease of the wall motion score of at least 1 point score.

  6 months after the procedure

Secondary Outcomes (4)

• LV end-systolic volume (ml)

  6 months and 12 months after the procedure

• LV end-diastolic volume (ml)

  6 months and 12 months after the procedure

• LV ejection fraction (%)

  6 months and 12 months after the procedure.

• Procedural success

  immediately after the procedure.

Study Arms (1)

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

Diagnostic Test: FAPI Imaging

Interventions

FAPI Imaging 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.

Patients with at least one untreated CTO at 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lin Zhao: lead
• Beijing Chao Yang Hospital: collaborator

Study Sites (2)

Beijing Chaoyang Hospital, Capital Medical University, Beijing, China

Beijing, Beijing Municipality, 100020, China

RECRUITING

Beijing Chaoyang Hospital, Capital Medical University, Beijing, China

Beijing, Beijing Municipality, 100020, China

RECRUITING

Related Publications (3)

• 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

• 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.

  PMID: 29852933 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

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Lin Zhao, Ph.D MD

  Beijing Chaoyang Hospital, Capital Medical University, Beijing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shengwen Yang, Ph.D, MD

CONTACT

+8617801014018; verayang1990@163.com

Bin Tu, Ph.D MD

CONTACT

+8618810682692; 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: October 5, 2024
• First Posted: October 24, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 24, 2024

Record last verified: 2024-10

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 (2)