Stockholm Myocardial Infarction With Normal Coronaries (SMINC)-2 Study on Diagnosis Made by Cardiac MRI

Study Overview
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Brief Summary
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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
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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).

Official Title
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Stockholm Myocardial Infarction With Normal Coronaries (SMINC)-2

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Procedure: CMR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prospective MINCA patients<br>Patients with MINCA prospectively investigated with an early CMR with latest technique | Procedure: CMR<br>* Intervention performed 2-4 days after admission to hospital with the latest CMR technique including sensitive oedema sequences using T1 mapping<br>|
| Placebo Comparator: Historical MINCA patients<br>Patients with MINCA investigated earlier with a late CMR (median 12 days) | Procedure: CMR<br>* Intervention performed 2-4 days after admission to hospital with the latest CMR technique including sensitive oedema sequences using T1 mapping<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of an early CMR with the latest technique | Show that the more patients get a definite diagnosis (70%) when compared to a historical sample (50%) | 2-4 days after admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with correct diagnosis with echocardiography | To study the accuracy of echocardiography compared to CMR using ROC | 12 months | 
| Number of patients with a postive CT angiography and infarction on CMR | To study CT angiography findings in relation to myocardial infarction shown by CMR | 1 month | 
| Describe QoL over time |  | 12 months |