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

Study Overview
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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).

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.

Official Title
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Identification of Risk Factors for Acute Coronary Events by Optical Coherence Tomography After STEMI and NSTEMI in Patients With Residual Non-flow Limiting Lesions The 'PECTUS-obs' Trial (Observational Cohort)

Conditions
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Myocardial Infarction, Acute Coronary Syndrome, Coronary Artery Disease

Intervention / Treatment
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* Device: Coronary Optical Coherence tomography


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Coronary OCT imaging of non flow-limiting lesion<br>Coronary OCT imaging will be performed of fractional flow reserve (FFR) negative lesions to assess plaque morphology. | Device: Coronary Optical Coherence tomography<br>* Optical coherence tomography imaging is performed of non-obstructive, non-culprit coronary lesions to assess plaque morphology.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events | Composite of all cause mortality, non-fatal myocardial infarction or unplanned revascularization. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events | Composite of all cause mortality, non-fatal myocardial infarction or unplanned revascularization. | 1 year | 
| Major Adverse Cardiac Events | Composite of all cause mortality, non-fatal myocardial infarction or unplanned revascularization. | 5 years | 
| Target lesion Failure | Cardiac death caused by target lesion, myocardial infarction caused by target lesion, revascularisation of target lesion | 2 and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vulnerable plaque, Optical coherence Tomography, OCT