Stockholm Myocardial Infarction with Nonobstructive Coronaries Study 3

NCT05426408 | Recruiting

• 1 other identifier: SMINC-3
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction with Nonobstructive Coronary Arteries

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield

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

  Through investigation completion, usually 2 hours

Secondary Outcomes (3)

• Prevalence of CMD in MINOCA

  Through investigation completion, usually 2 hours

• Prevalence of CMD in different final MINOCA diagnoses

  Through investigation completion, usually 2 hours

• Angina pectoris

  3 Months

Study Arms (1)

Patients with MINOCA undergoing CMR

OTHER

Patients will be their own controls

Diagnostic Test: Cardiac magnetic resonance imaging to study coronary microvascular dysfunction

Interventions

Cardiac magnetic resonance imaging to study coronary microvascular dysfunction DIAGNOSTIC_TEST

Myocardial perfusion mapping will be investigated after administration of adenosine

Patients with MINOCA undergoing CMR

Eligibility Criteria

• Age: 35 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Per Tornvall

Stockholm, 11551, Sweden

RECRUITING

MeSH Terms

Conditions

MINOCA

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Per Tornvall, MD

  Karolinska Instítutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Per Tornvall, MD

CONTACT

+468616100; per.tornvall@ki.se

Peder Sörensson, MD

CONTACT

+46812370000; perder.sorensson@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The investigators who will perform the evaluation of the CMR investigations will be blinded to all clinical data.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be their own controls

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 22, 2022
• Study Start: November 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 10, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)