Actively Recruiting

Age: 18Years +
All Genders
NCT06655922

FAPI Imaging Assessment of Chronic Total Occlusion

Led by Lin Zhao · Updated on 2024-10-24

167

Participants Needed

2

Research Sites

102 weeks

Total Duration

On this page

Sponsors

L

Lin Zhao

Lead Sponsor

B

Beijing Chao Yang Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

FAPI Imaging Assessment of Chronic Total Occlusion

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age > 18 years
  • Presence of at least one untreated chronic total occlusion in a major coronary vessel or relevant side branch, with total blockage (TIMI 0) distal segment and at least 3 months old
  • Clinical indication to undergo percutaneous coronary intervention (PCI) for CTO
  • Ability and willingness to understand, read, and sign informed consent
Not Eligible

You will not qualify if you...

  • Allergy or hypersensitivity to aspirin, clopidogrel, or drugs in the -limus family, or contraindication to antiplatelet agents
  • Severe liver dysfunction with levels 3 times above normal
  • Severe chronic kidney disease with estimated glomerular filtration rate below 30 mL/min/1.73m2
  • Life expectancy less than 1 year
  • Pregnancy or potential childbearing in women

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Beijing Chaoyang Hospital, Capital Medical University, Beijing, China

Beijing, Beijing Municipality, China, 100020

Actively Recruiting

2

Beijing Chaoyang Hospital, Capital Medical University, Beijing, China

Beijing, Beijing Municipality, China, 100020

Actively Recruiting

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Research Team

S

Shengwen Yang, Ph.D, MD

CONTACT

B

Bin Tu, Ph.D MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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