Stockholm Myocardial Infarction With Nonobstructive Coronaries Study 3

Myocardial Infarction With Nonobstructive Coronary Arteries Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05426408
• Other study ID #: SMINC-3
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: March 2023
• Source: Karolinska Institutet
• Contact: Per Tornvall, MD
• Phone: +468616100
• Email: per.tornvall[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Myocardial Infarction With Nonobstructive Coronary Arteries

Intervention

Diagnostic Test:
• Cardiac magnetic resonance imaging to study coronary microvascular dysfunction
Myocardial perfusion mapping will be investigated after administration of adenosine

Locations

Country	Name	City	State
Sweden	Per Tornvall	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield	To increase the diagnostic yield of CMR imaging in MINOCA as a working diagnosis	Through investigation completion, usually 2 hours
Secondary	Prevalence of CMD in MINOCA	To determine the proportion of patients with the working diagnosis of MINOCA who have CMD.	Through investigation completion, usually 2 hours
Secondary	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	Through investigation completion, usually 2 hours
Secondary	Angina pectoris	To investigate the occurrence of angina pectoris before inclusion and after 3 months and relate it to CMD	3 Months