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

Karolinska Institute

Status: Completed

Conditions: Myocardial Infarction

Treatments: Procedure: CMR

Study type: Interventional

Funder types: Other

Identifiers

NCT02318498

2

Details and patient eligibility

About

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.

Full 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).

Enrollment: 150 patients

Sex: All

Ages: 35 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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150 participants in 2 patient groups, including a placebo group

Prospective MINCA patients

Active Comparator group

Description:

Patients with MINCA prospectively investigated with an early CMR with latest technique

Treatment:

Procedure: CMR

Historical MINCA patients

Placebo Comparator group

Description:

Patients with MINCA investigated earlier with a late CMR (median 12 days)

Treatment:

Procedure: CMR