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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2019-04-30

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.

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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).

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Prospective MINCA patients

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

Group Type ACTIVE_COMPARATOR

CMR

Intervention Type PROCEDURE

Intervention performed 2-4 days after admission to hospital with the latest CMR technique including sensitive oedema sequences using T1 mapping

Historical MINCA patients

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

Group Type PLACEBO_COMPARATOR

CMR

Intervention Type PROCEDURE

Intervention performed 2-4 days after admission to hospital with the latest CMR technique including sensitive oedema sequences using T1 mapping

Interventions

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CMR

Intervention performed 2-4 days after admission to hospital with the latest CMR technique including sensitive oedema sequences using T1 mapping

Intervention Type PROCEDURE

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

Minimum Eligible Age

35 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No