Role of Intracoronary Imaging in Plaque Identification

NCT03953040 | Withdrawn FDA Device

• 1 other identifier: OCTIVUS2019
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation between OCT and IVUS findings and the new score

  6 months

Interventions

intracoronary imaging (IVUS, OCT) DIAGNOSTIC_TEST

Patients presenting with non STE-ACS will be subjected after performing PCI of the culprit lesion to intracoronary imaging with the help of IVUS and OCT of the non-culprit lesions to detect and image the so-called vulnerable plaques

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 18 years and more
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Amr A. Amr, MD

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 16, 2019
• Study Start: April 1, 2019
• Primary Completion: November 30, 2020
• Study Completion: March 1, 2021
• Last Updated: January 22, 2020

Record last verified: 2020-01