An observational study in Chronic Total Occlusion (CTO), sponsored by Lin Zhao. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-24.
Sponsored by Lin Zhao · Observational
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.
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.
Lin Zhao is the lead sponsor of 5 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients presenting with at least one coronary chronic total occlusion (CTO) on coronary angiogram who will be treated by percutaneous coronary intervention
Exclusion Criteria:
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
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.
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.
Time frame: 6 months after the procedure
LV end-systolic volume (ml)
LV function was assessed by modified Simpson's method.Volumes were obtained by delineation of inner and outer LV contours in end-systolic frames on cardiac SPECT, echocardiography or cardiac magnetic resonance.
Time frame: 6 months and 12 months after the procedure
LV end-diastolic volume (ml)
LV function was assessed by modified Simpson's method. LV end-diastolic volume was obtained by delineation of inner and outer LV contours in end-diastolic frames on cardiac SPECT, echocardiography or cardiac magnetic resonance.
Time frame: 6 months and 12 months after the procedure
LV ejection fraction (%)
LV function was assessed by modified Simpson's method. Ejection fraction (EF) was computed from the EDV and ESV as follows:EF=EDV-ESV/EDV on cardiac SPECT, echocardiography or cardiac MRI.
Time frame: 6 months and 12 months after the procedure.
Procedural success
Procedural success was defined as successful recanalization of the intended CTO lesion with DES implantation, restoration of Thrombolysis In Myocardial Infarction flow grade 3, and residual diameter stenosis \<30% on visual assessment.
Time frame: immediately after the procedure.
Plan to share: Yes — Only IPD used in the results publication
Supporting information: Study protocol, Sap, Icf
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Lin Zhao