Identification of Risk Factors for Acute Coronary Events by OCT After STEMI and NSTEMI in Patients With Residual Non-flow Limiting Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

438 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-14

Study Completion Date

2025-06-14

Brief Summary

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The objective of this study is to compare the clinical outcome of Non-ST-elevation myocardial infarction (NSTEMI) and ST-elevation myocardial infarction (STEMI) patients with non-obstructive, non-culprit coronary lesions and either presence or absence of vulnerable plaque characteristics as assessed by optical coherence tomography (OCT).

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Detailed Description

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Despite major advances in the treatment of acute coronary syndromes a large proportion of patients is still at risk for new coronary events after experiencing an acute coronary syndrome (ACS). Detection of residual vulnerable plaques after ACS using OCT potentially identifies patients at high risk for new coronary events. However, no prospectively collected data on the prognostic power of OCT for plaque rupture are available at this moment. To design trials aimed to reduce events in patients with vulnerable plaques it is required to collect such prospective data on the relation between OCT derived characteristics of vulnerability and clinical outcome.

Conditions

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Myocardial Infarction Acute Coronary Syndrome Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Coronary OCT imaging of non flow-limiting lesion

Coronary OCT imaging will be performed of fractional flow reserve (FFR) negative lesions to assess plaque morphology.

Group Type OTHER

Coronary Optical Coherence tomography

Intervention Type DEVICE

Optical coherence tomography imaging is performed of non-obstructive, non-culprit coronary lesions to assess plaque morphology.

Interventions

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Coronary Optical Coherence tomography

Optical coherence tomography imaging is performed of non-obstructive, non-culprit coronary lesions to assess plaque morphology.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Informed consent must be obtained.
* Patients with STEMI or NSTEMI and residual, non-culprit CAD, with the possibility of plaque vulnerability.
* Residual plaque(s) is(are) non-obstructive (FFR≥0.80).

Exclusion Criteria

* Refusal or inability to provide informed consent.
* \< 18 years of age
* Hemodynamic instability, respiratory failure, Kilip class ≥ 3.
* Previous Coronary Artery Bypass Grafting (CABG).
* Indication for revascularization by CABG.
* Anatomy or lesions unsuitable for OCT catheter crossing or imaging (aorta-ostial lesions, small diameter segment, severe calcifications, lesion is too distal for OCT catheter)
* Pregnancy.
* Estimated life expectancy \< 3 year

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No