Role of Intracoronary Imaging in Plaque Identification

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03953040
• Other study ID #: OCTIVUS2019
• Status: Withdrawn
• Start date: April 1, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: January 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older
• Eligibility: No formal inclusion or exclusion criteria

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Diagnostic Test:
• intracoronary imaging (IVUS, OCT)
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation between OCT and IVUS findings and the new score		6 months