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

Coronary Artery Disease Clinical Trial

— PECTUS-obs  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03857971
• Other study ID #: NL67426.091.18
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 14, 2018
• Est. completion date: June 14, 2025

Study information

• Verified date: September 2021
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 438
• Est. completion date: June 14, 2025
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Infarction
• Myocardial Infarction

Intervention

Device:
• Coronary Optical Coherence tomography
Optical coherence tomography imaging is performed of non-obstructive, non-culprit coronary lesions to assess plaque morphology.

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

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