Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
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
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here