Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655922
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-05
Brief Title:
FAPI Imaging Assessment of Chronic Total Occlusion
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Clinical Value of FAPI Imaging in Assessing Chronic Total Occlusion Lesions in Patients with Coronary Heart Disease FACT Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FACT
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 FDGperfusion 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
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 FDGperfusion 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None