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Clinical Trials/NCT02318498
NCT02318498
Completed
Not Applicable

Stockholm Myocardial Infarction With Normal Coronaries (SMINC)-2

Karolinska Institutet1 site in 1 country150 target enrollmentNovember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocardial Infarction
Sponsor
Karolinska Institutet
Enrollment
150
Locations
1
Primary Endpoint
Diagnostic accuracy of an early CMR with the latest technique
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Myocardial infarction with angiographically normal coronary arteries (MINCA) is common (7-8 % of all myocardial infarctions). There are several different causes behind MINCA where "true infarction" due to thromboembolism, myocarditis or Takotsubo stress cardiomyopathy are the main findings. The underlying diagnosis is often made by clinical findings sometimes with the help of cardiac MRI (CMR). Investigators have previously shown that it was possible to give 50 % of the patients a diagnosis made by the combination of clinical findings and CMR made in median 12 days after the acute event. The present study aim at improve the diagnostic accuracy by an early CMR with latest technique.

Detailed Description

The present study aim at improve the diagnostic accuracy in MINCA with an CMR made 2-4 days after the acute event. The aim is to give 70 % of all patients with MINCA (35-70 years old) a definitive diagnosis made by CMR only. One-hundred and fifty patients will be included and compared with a similar historical sample where 50 % of the patients received a diagnosis made by a late CMR and clinical findings. The study has 80 % power to detect this 20 % absolute difference (p \<0.05).

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
April 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Per Tornvall

Associate professor

Karolinska Institutet

Eligibility Criteria

Inclusion Criteria

  • 35-70 years
  • Fullfill the diagnosic criteria of myocardial infarction
  • Normal coronary angiography or minor atheromatosis
  • Sinus rythm on ECG at admission

Exclusion Criteria

  • Previous myocardial infarction
  • Known cardiomyopathy
  • Pacemaker or claustrophobia
  • Severe chronic obstructive lung or kidney disease
  • Pulmonary embolism

Outcomes

Primary Outcomes

Diagnostic accuracy of an early CMR with the latest technique

Time Frame: 2-4 days after admission

Show that the more patients get a definite diagnosis (70%) when compared to a historical sample (50%)

Secondary Outcomes

  • Number of patients with correct diagnosis with echocardiography(12 months)
  • Describe QoL over time(12 months)
  • Number of patients with a postive CT angiography and infarction on CMR(1 month)

Study Sites (1)

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