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

Primary Purpose

Myocardial Infarction With Nonobstructive Coronary Arteries

Status

Recruiting

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Cardiac magnetic resonance imaging to study coronary microvascular dysfunction

About this trial

This is an interventional diagnostic trial for Myocardial Infarction With Nonobstructive Coronary Arteries

Eligibility Criteria

35 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Per TornvallRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with MINOCA undergoing CMR

Arm Description

Patients will be their own controls

Outcomes

Primary Outcome Measures

Diagnostic yield

To increase the diagnostic yield of CMR imaging in MINOCA as a working diagnosis

Secondary Outcome Measures

Prevalence of CMD in MINOCA

To determine the proportion of patients with the working diagnosis of MINOCA who have CMD.

Prevalence of CMD in different final MINOCA diagnoses

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

Angina pectoris

To investigate the occurrence of angina pectoris before inclusion and after 3 months and relate it to CMD

Full Information

NCT ID

NCT05426408

First Posted

June 10, 2022

Last Updated

March 14, 2023

Sponsor

Karolinska Institutet

Collaborators

Region Stockholm

1. Study Identification

Unique Protocol Identification Number

NCT05426408

Brief Title

Stockholm Myocardial Infarction With Nonobstructive Coronaries Study 3

Acronym

SMINC-3

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

Collaborators

Region Stockholm

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction With Nonobstructive Coronary Arteries

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Patients will be their own controls

Masking

None (Open Label)

Masking Description

The investigators who will perform the evaluation of the CMR investigations will be blinded to all clinical data.

Allocation

N/A

Enrollment

85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with MINOCA undergoing CMR

Arm Type

Other

Arm Description

Patients will be their own controls

Intervention Type

Diagnostic Test

Intervention Name(s)

Cardiac magnetic resonance imaging to study coronary microvascular dysfunction

Intervention Description

Myocardial perfusion mapping will be investigated after administration of adenosine

Primary Outcome Measure Information:

Title

Diagnostic yield

Description

To increase the diagnostic yield of CMR imaging in MINOCA as a working diagnosis

Time Frame

Through investigation completion, usually 2 hours

Secondary Outcome Measure Information:

Title

Prevalence of CMD in MINOCA

Description

To determine the proportion of patients with the working diagnosis of MINOCA who have CMD.

Time Frame

Through investigation completion, usually 2 hours

Title

Prevalence of CMD in different final MINOCA diagnoses

Description

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

Time Frame

Through investigation completion, usually 2 hours

Title

Angina pectoris

Description

To investigate the occurrence of angina pectoris before inclusion and after 3 months and relate it to CMD

Time Frame

3 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Per Tornvall, MD

Phone

+468616100

per.tornvall@ki.se

First Name & Middle Initial & Last Name or Official Title & Degree

Peder Sörensson, MD

Phone

+46812370000

perder.sorensson@regionstockholm.se

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Per Tornvall, MD

Organizational Affiliation

Karolinska Instítutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Per Tornvall

City

Stockholm

ZIP/Postal Code

11551

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Per Tornvall

Phone

+46722180560

per.tornvall@ki.se

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Stockholm Myocardial Infarction With Nonobstructive Coronaries Study 3

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