Culprit Lesions in NSTEMI With Multi Vessel Disease (NSTEMI-CULPRIT) (NS-CULPRIT)

March 28, 2023 updated by: Thomas Engstrom, Rigshospitalet, Denmark

Identification of Culprit Lesions in Non ST-elevation Myocardial Infarction and Multivessel Disease

Acute myocardial infarction owes to a plaque rupture resulting in total (STEMI) or partial occlusion (NSTEMI) of the coronary artery. In patients with a partial occlusion and multi vessel disease (MVD), identification of the lesion responsible for the current event (culprit) at the time of the examination (coronary angiogram, CAG) can be difficult.

Meanwhile, identification of the culprit lesion is vital to conduct proper treatment. Furthermore, treating an artery with no plaque rupture (non-culprit), imposes a small risk for complications, which may be fatal. Precise identification of the culprit lesion in NSTEMI patients with MVD remains unsettled

The purpose of this study is proper and precise identification of the culprit lesion in NSTEMI patients with MVD.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background

Acute myocardial infarction owes to a plaque rupture resulting in total (STEMI) or partial occlusion (NSTEMI) of the coronary artery. Current guidelines in NSTEMI recommend an invasive coronary angiogram (CAG) and possible treatment with percutaneous intervention (PCI) within 2-72 hours. In NSTEMI patients and multi vessel disease (MVD), identification of the lesion responsible for the current event (culprit) at the time of the examination can be difficult.

Meanwhile, identification of the culprit lesion is vital to conduct proper treatment in order to restore blood flow to the myocardium. Furthermore, treating an artery with no plaque rupture (non-culprit), imposes a small risk for complications, which may be fatal. In addition, since the symptoms relate to the culprit lesion it is currently unclear whether all stenosis or only the culprit should be treated by PCI. Today precise identification of the culprit lesion in NSTEMI patients with MVD remains unsettled.

Purpose

The overall objective of this study is proper and precise identification of the culprit lesion in NSTEMI patients with MVD.

Methods

The study employs cardiac magnetic resonance (CMR), which allows detection of myocardium exposed to even brief periods of ischemia. Furthermore, Optical Coherence Tomography (OCT) which visualises the coronary artery lumen and wall. OCT allows for direct visualization of atherosclerotic plaques, presence of thrombus and atherosclerotic plaque ruptured that cannot be seen on a CAG alone.

Patients will have CMR performed prior to CAG. The PCI operator determines culprit based on CAG and ECG changes alone. OCT is subsequently performed on culprit lesion(s) and stenosis ≥ 50%.

Sample size calculation

Assuming the culprit lesion can be correctly identified with history/angiography/ECG in 95% of cases a positive predictive value >90% with 95% accuracy can be reached with 100 patients.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

Sampling Method

Non-Probability Sample

Study Population

Eligible NSTEMI patients scheduled for CAG at one center

Description

Inclusion Criteria:

  • Patients > 18 years of age
  • NSTEMI (ECG changes and/or troponin/creatine kinase myocardial band (CK-MB) rise) within 48 hours after symptom debut.
  • Multivessel disease at CAG: More than one vessel with >50% stenosis.

Exclusion Criteria:

  • Known intolerance of heparin or contrast medium.
  • Inability to understand information or to provide informed consent.
  • estimated glomerular filtration rate (eGFR) < 30 ml/min.
  • Other reasons for troponin rise not applicable to acute myocardial infarction.
  • Atrial fibrillation at admission.
  • Patients with contraindication for CMR will only have OCT performed.
  • Potential pregnancy
  • Unstable patients requiring acute CAG and PCI

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CMR and OCT in NSTEMI patients with MVD
NSTEMI patients with multi vessel disease
Diagnostic test: CMR and OCT in NSTEMI patients with MVD
Lesions >50% stenosis i patients with NSTEMI are examined by OCT. All patients will have CMR performed prior to angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Is the PCI operator capable of identifying the culprit lesion based on ECG-changes and CAG? (CMR is the golden standard)
Time Frame: Through study completion, an average of 1 year
Correlation between operator identification of the culprit and CMR/OCT. The location of the culprit on CAG/ECG and OCT versus CMR will be evaluated by the chi2-test
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive predictive value of PCI operator identification of culprit lesion with CAG and ECG.
Time Frame: Through study completion, an average of 1 year
cross-tables will be used to calculate the positive predictive value Receiver-operating-characteristics will be used to compare the additional diagnostic value of OCT compared to CAG/ECG.
Through study completion, an average of 1 year
Improvement in identification of culprit lesions evaluated by identification of an additional diagnostic value of OCT compared to CAG/ECG
Time Frame: Through study completion, an average of 1 year
Receiver-operating-characteristics will be used to compare the additional diagnostic value of OCT compared to CAG/ECG. CMR is the golden standard.
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Thomas Engstrøm, DMSCi, PhD, Rigshospitalet, University of Copenhagen

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)

January 10, 2018

Primary Completion (Actual)

January 1, 2022

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

November 27, 2017

First Submitted That Met QC Criteria

March 20, 2018

First Posted (Actual)

March 27, 2018

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-17023377

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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