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WithdrawnNCT03953040Updated Jan 22, 2020

Role of Intracoronary Imaging in Plaque Identification

An observational study in Coronary Artery Disease, sponsored by Assiut University. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-22.

Sponsored by Assiut University · Observational

Why this study was withdrawn
Funding Issues
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

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Conditions studied

  • Coronary Artery Disease
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

Browse Coronary Artery Disease studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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).

Eligibility criteria

No formal inclusion or exclusion criteria

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
0 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testintracoronary 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

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What researchers measure

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

    Time frame: 1 year-duration

Secondary outcomes

  1. Correlation between OCT and IVUS findings and the new score

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03953040
Lead sponsor
Assiut University
Responsible party
Ayat Aboutaleb Abdellah Abdelgalil (Assistant lecturer, Assiut University) — Principal investigator
First posted
May 16, 2019
Start date
Apr 1, 2019
Primary completion
Nov 30, 2020 (estimated)
Completion
Mar 1, 2021 (estimated)
Last update
Jan 22, 2020

Study contacts

Amr A. Amr, MD
study director · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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