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RecruitingNCT05426408SMINC-3Updated Mar 10, 2025

Stockholm Myocardial Infarction with Nonobstructive Coronaries Study 3

An interventional study of Cardiac magnetic resonance imaging to study coronary microvascular dysfunction in Myocardial Infarction with Nonobstructive Coronary Arteries, sponsored by Karolinska Institutet. Recruiting at 1 site in Sweden. Open to participants aged 35 Years to 79 Years. Per ClinicalTrials.gov, last updated 2025-03-10.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
85
Allocation
Not applicable
Ages
35 Years to 79 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Myocardial Infarction with Nonobstructive Coronary Arteries
03

Who can participate

Ages eligible
35 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
85 participants (estimated)

Study arms

  • Other
    Patients with MINOCA undergoing CMR

    Patients will be their own controls

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

Interventions

  • Diagnostic testCardiac magnetic resonance imaging to study coronary microvascular dysfunction

    Myocardial perfusion mapping will be investigated after administration of adenosine

05

What researchers measure

Primary outcomes

  1. Diagnostic yield

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

    Time frame: Through investigation completion, usually 2 hours

Secondary outcomes

  1. Prevalence of CMD in MINOCA

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

    Time frame: Through investigation completion, usually 2 hours

  2. 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

    Time frame: Through investigation completion, usually 2 hours

  3. Angina pectoris

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

    Time frame: 3 Months

06

Study locations

1 of 1 sites recruiting
  • Per Tornvall
    Stockholm, 11551, Sweden
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05426408
Lead sponsor
Karolinska Institutet
Collaborators
Region Stockholm
Responsible party
Per Tornvall (Professor, Karolinska Institutet) — Principal investigator
First posted
Jun 22, 2022
Start date
Nov 1, 2022
Primary completion
Dec 31, 2025 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Mar 10, 2025

Study contacts

Per Tornvall, MD
Contact
per.tornvall@ki.se
+468616100
Peder Sörensson, MD
Contact
perder.sorensson@regionstockholm.se
+46812370000
Per Tornvall, MD
principal investigator · Karolinska Instítutet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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