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

Not Applicable

Active, not recruiting

• Conditions: Myocardial Infarction; Acute Coronary Syndrome; Coronary Artery Disease
• Interventions: Device: Coronary Optical Coherence tomography

• Registration Number: NCT03857971
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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).

Detailed Description

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2018-12-14
• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-02-27
• Study First Posted: 2019-02-28
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-16
• Last Update Posted: 2021-09-17
• Primary Completion: 2022-09-15
• Study Completion: 2025-06-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 438

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).

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Coronary OCT imaging of non flow-limiting lesion	Coronary Optical Coherence tomography	Coronary OCT imaging will be performed of fractional flow reserve (FFR) negative lesions to assess plaque morphology.

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events	2 years	Composite of all cause mortality, non-fatal myocardial infarction or unplanned revascularization.

Secondary Outcome Measures

Name	Time	Method
Target lesion Failure	2 and 5 years	Cardiac death caused by target lesion, myocardial infarction caused by target lesion, revascularisation of target lesion
Major Adverse Cardiac Events	5 years	Composite of all cause mortality, non-fatal myocardial infarction or unplanned revascularization.

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Zuid-Holland, Netherlands