Ignite Creation Date:
2024-05-06 @ 1:12 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03953040
Status:
WITHDRAWN
Last Update Posted:
2020-01-22
First Post:
2019-05-14
Brief Title:
Role of Intracoronary Imaging in Plaque Identification
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Integrated Role of Intravascular Ultrasound and Optical Coherence Tomography to Define a New Plaque Vulnerability Score A Pilot Study in Non STE-ACS
Status:
WITHDRAWN
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding Issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
NSTE-ACS patients are more likely to exhibit high-risk plaque characteristics in non-culprit lesions Both IVUS and OCT imaging techniques interact in a complementary manner to provide morphological characterization of the atherosclerotic coronary plaques and help identification of high-risk vulnerable plaques Using morphological parameters obtained from OCT and IVUS a new plaque vulnerability score will be established for more precise definition of the most vulnerable plaques that carry the greatest risk of rupture and subsequent detrimental clinical outcomes in the future Such score might help in targeting these plaques with certain therapeutic interventions aiming to their stabilization
Detailed Description:
Patients with NSTE-ACS presented to the study site fulfilling the eligibility criteria during enrollment period of 1 year The culprit lesions being responsible for the acute event will be revascularized by percutaneous coronary intervention PCI Both OCT OPTISTM St Jude Medical Inc St Paul MN USA and IVUS Boston Scientific iLabTM Ultrasound Imaging System MA USA will be performed after PCI to examine the non-culprit lesions for detection of atherosclerotic plaques with the morphological characteristics consistent with high-risk plaques namely Vulnerable plaques Plaque characteristics from IVUS and OCT imaging will be merged to establish novel scores which help improve diagnostic accuracy for detection of high-risk lesions Correlations IVUS and OCT images will be performed to identify most reliable factors associated with plaque vulnerabilityPatients will be followed up to 6 months after PCI for detection of major adverse cardiovascular outcomes MACE after ischaemia-driven revascularization of the culprit lesions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None