Role of Intracoronary Imaging in Plaque Identification

Integrated Role of Intravascular Ultrasound and Optical Coherence Tomography to Define a New Plaque Vulnerability Score: A Pilot Study in Non STE-ACS

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.

Study Overview

• Status: Withdrawn
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: intracoronary imaging (IVUS, OCT)

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study subjects are patients with history of non-ST elevation acute coronary syndrome (NSTE-ACS):

• *Diagnosis of NSTE-ACS: history of prolonged anginal pain (more 20 min) at rest, or recent instability of previously stable angina pectoris (at least Canadian Society Cardiovascular angina class III), or post-MI angina, together with ST segment or T wave changes. According to the results of cardiac biomarker, NSTE-ACS is subdivided into: NSTEMI (with +ve cardiac biomarkers) and unstable angina (with -ve cardiac biomarkers).

Description

No formal inclusion or exclusion criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation between OCT and IVUS findings and the new score	6 months

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Amr A. Amr, MD, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 19, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: OCTIVUS2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes