FAPI Imaging for Chronic Total Occlusion Treatment
FAPI Imaging Assessment of Chronic Total Occlusion
Recruiting
Observational Study
Chronic Total Occlusion (CTO)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
167 (estimated)
Sponsor
Lin Zhao · Other
Who this trial is looking for
This trial is looking for adult patients with at least one untreated chronic total coronary occlusion, which is a blockage in their heart arteries. Participants will undergo imaging to help understand their condition and treatment options better.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 18 years old.
I have at least one untreated chronic total coronary occlusion.
I need to have a procedure called CTO PCI.
I can read, understand, and sign the consent form.
You may not be able to join if
I am allergic to aspirin or clopidogrel.
I have severe liver problems.
I have severe chronic kidney disease.
My doctor thinks I have less than 1 year to live.
I am pregnant or could become pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
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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 fibrobla…
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.
Trial Locations
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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 …
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
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