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

Not Applicable

Completed

• Conditions: Myocardial Infarction
• Interventions: Procedure: CMR

• Registration Number: NCT02318498
• Lead Sponsor: Karolinska Institutet

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).

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-12-05
• Study First Submitted QC: 2014-12-12
• Study First Posted: 2014-12-17
• Primary Completion: 2018-11
• Study Completion: 2019-04
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-04
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Historical MINCA patients	CMR	Patients with MINCA investigated earlier with a late CMR (median 12 days)
Prospective MINCA patients	CMR	Patients with MINCA prospectively investigated with an early CMR with latest technique

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden