Clinical trial NCT03857971: Identification of Risk Factors for Acute Coronary Events by OCT After STEMI and NSTEMI in Patients With Residual Non-flow Limiting Lesions
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction
Acute Coronary Syndrome
Coronary Artery Disease
Keywords: Vulnerable plaque
Optical coherence Tomography
OCT
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 438
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major Adverse Cardiac Events
timeFrame: 2 years
Secondary outcomes:
measure: Major Adverse Cardiac Events
timeFrame: 1 year
measure: Major Adverse Cardiac Events
timeFrame: 5 years
measure: Target lesion Failure
timeFrame: 2 and 5 years
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Zuid-Holland
Study officials:
affiliation: Radboud University Medical Center
name: Niels van Royen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mol JQ, Belkacemi A, Volleberg RH, Meuwissen M, Protopopov AV, Laanmets P, Krestyaninov OV, Dennert R, Oemrawsingh RM, van Kuijk JP, Arkenbout K, van der Heijden DJ, Rasoul S, Lipsic E, Teerenstra S, Camaro C, Damman P, van Leeuwen MA, van Geuns RJ, van Royen N. Identification of anatomic risk factors for acute coronary events by optical coherence tomography in patients with myocardial infarction and residual nonflow limiting lesions: rationale and design of the PECTUS-obs study. BMJ Open. 2021 Jul 7;11(7):e048994. doi: 10.1136/bmjopen-2021-048994.