Stockholm Myocardial Infarction With Nonobstructive Coronaries Study 3 (SMINC-3)

March 14, 2023 updated by: Per Tornvall, Karolinska Institutet

Stockholm Myocardial Infarction With Nonobstructive Coronaries Study 3 - Pilot Study of Prevalence of Coronary Microvascular Dysfunction in Myocardial Infarction With Nonobstructive Coronary Arteries

The present pilot study will investigate the prevalence of CMD in an unselected cohort of patients with the working diagnosis MINOCA and to study if the diagnostic yield can be improved by adding adenosine to the CMR investigation. Patient will be their own controls.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

85

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 Contact

Study Contact Backup

Study Locations

  • Sweden
      • Stockholm, Sweden, 11551
        • Recruiting
        • Per Tornvall
        • Contact:

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

35 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • a suspected diagnosis of MINOCA or takotsubo syndrome with coronary angiography without diameter stenosis ≥50%
  • age 35-80 years
  • reading and writing proficiency in Swedish

Exclusion Criteria:

  • Claustrofobia
  • Arrythmia and/or pacemaker (atrial fibrillation and AV-block I- III)
  • Asthma or severe chronic obstructive lung disease
  • eGFR < 30 ml/min
  • spontaneous coronary artery dissection
  • acute pulmonary embolism
  • acute myocardial infarction type 2
  • cardiomyopathy other than takotsubo syndrome
  • a previous myocardial infarction due to CAD

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: Patients with MINOCA undergoing CMR
Patients will be their own controls
Diagnostic test: Cardiac magnetic resonance imaging to study coronary microvascular dysfunction
Myocardial perfusion mapping will be investigated after administration of adenosine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic yield
Time Frame: Through investigation completion, usually 2 hours
To increase the diagnostic yield of CMR imaging in MINOCA as a working diagnosis
Through investigation completion, usually 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of CMD in MINOCA
Time Frame: Through investigation completion, usually 2 hours
To determine the proportion of patients with the working diagnosis of MINOCA who have CMD.
Through investigation completion, usually 2 hours
Prevalence of CMD in different final MINOCA diagnoses
Time Frame: Through investigation completion, usually 2 hours
To study the proportions of CMD in patients with a CMR imaging diagnosis of myocardial infarction, Takotsubo, respectively myocarditis and compare them with the results from a healthy control group
Through investigation completion, usually 2 hours
Angina pectoris
Time Frame: 3 Months
To investigate the occurrence of angina pectoris before inclusion and after 3 months and relate it to CMD
3 Months

Collaborators and Investigators

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

Sponsor

Karolinska Institutet

Collaborators

Region Stockholm

Investigators

  • Principal Investigator: Per Tornvall, MD, Karolinska Institutet

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)

November 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

March 31, 2024

Study Registration Dates

First Submitted

June 10, 2022

First Submitted That Met QC Criteria

June 16, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMINC-3

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.

Clinical Trials on Myocardial Infarction With Nonobstructive Coronary Arteries

Clinical Trials on Cardiac magnetic resonance imaging to study coronary microvascular dysfunction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe