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

Radboud University Medical Center

Status: Active, not recruiting

Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Myocardial Infarction

Treatments: Device: Coronary Optical Coherence tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT03857971

NL67426.091.18

Details and patient eligibility

About

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).

Full 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.

Enrollment: 438 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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438 participants in 1 patient group

Coronary OCT imaging of non flow-limiting lesion

Other group

Description:

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

Treatment:

Device: Coronary Optical Coherence tomography