Role of Intracoronary Imaging in Plaque Identification

Withdrawn

• Conditions: Coronary Artery Disease

• Registration Number: NCT03953040
• Lead Sponsor: Assiut University

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 lesion(s) 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 lesion(s) 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 vulnerability.Patients will be followed up to 6 months after PCI for detection of major adverse cardiovascular outcomes (MACE) after ischaemia-driven revascularization of the culprit lesion(s).

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-16
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-19
• Last Update Posted: 2020-01-22
• Primary Completion: 2020-11-30
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establishment of a new plaque vulnerability score to define vulnerable plaques by IVUS and OCT imaging.	1 year-duration	Retrospective analysis of the collected OCT and IVUS data

Secondary Outcome Measures

Name	Time	Method
Correlation between OCT and IVUS findings and the new score	6 months