Plaque Burden and Ischemia in MINOCA

November 28, 2023 updated by: Mai Tone Lønnebakken, University of Bergen

Coronary Artery Plaque, Perivascular Inflammation and Myocardial Ischemia in Patients With Myocardial Infraction and Non-obstructive Coronary Arteries

The goal of this clinical trial is to assess coronary artery plaque burden, perivascular inflammation and extent of myocardial ischemia in patients presenting with acute myocardial infarction and non-obstructive coronary artery disease. The main question it aims to answer are:

  • Identify coronary artery anatomy, plaque burden, composition and high-risk plaque features by CT coronary angiography in MINOCA
  • Assess presence, extent and severity of myocardial ischemia in MINOCA

Participants will examined by CT coronary angiography and stress [12N] NH3 PET-MR.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

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

  • Norway
      • Bergen, Norway, 5021
        • Recruiting
        • Department of Clinical Science, University of Bergen
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Terje H Larsen, MD phd
        • Sub-Investigator:
          • Silja Hanseth, MD

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

Sampling Method

Probability Sample

Study Population

Patients hospitalized with acute myocardial infarction and non-obstructive coronary artery disease by coronary angiography

Description

Inclusion Criteria:

  • Acute chest pain
  • Elevated troponin
  • Non-obstructive coronary arteries by coronary angiography

Exclusion Criteria:

  • Obstructive coronary artery disease
  • Contraindications against CT coronary angiography or stress [12N] NH3 PET-MR
  • Not able to give informed consent

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CT coronary angiography and [12N] NH3 PET-MR
All patients will undergo CT coronary angiography and stress [12N] NH3 PET-MR
Diagnostic test: CT coronary angiography and [12N] NH3 PET-MR
Advanced coronary artery plaque analysis, myocardial ischemia and coronary flow reserve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plaque burden
Time Frame: 1 week
1 week
Myocardial ischemia
Time Frame: 1 week
1 week

Collaborators and Investigators

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

Sponsor

University of Bergen

Collaborators

Haukeland University Hospital
Haraldsplass Deaconess Hospital

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)

August 15, 2023

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

January 3, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 463549

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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