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

September 16, 2021 updated by: Radboud University Medical Center

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)

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

438

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid-Holland
      • Nijmegen, Zuid-Holland, Netherlands, 6500HB
        • Radboudumc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional 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
Coronary OCT imaging will be performed of fractional flow reserve (FFR) negative lesions to assess plaque morphology.
Device: Coronary Optical Coherence tomography
Optical coherence tomography imaging is performed of non-obstructive, non-culprit coronary lesions to assess plaque morphology.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Niels van Royen, MD, PhD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2018

Primary Completion (Anticipated)

September 15, 2022

Study Completion (Anticipated)

June 14, 2025

Study Registration Dates

First Submitted

February 27, 2019

First Submitted That Met QC Criteria

February 27, 2019

First Posted (Actual)

February 28, 2019

Study Record Updates

Last Update Posted (Actual)

September 17, 2021

Last Update Submitted That Met QC Criteria

September 16, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL67426.091.18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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