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NCT Number: NCT02318498

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

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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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

35 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CMR

Procedure

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

Primary outcomes

  1. 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

  1. Number of patients with correct diagnosis with echocardiography

    Time frame: 12 months

    To study the accuracy of echocardiography compared to CMR using ROC

  2. Number of patients with a postive CT angiography and infarction on CMR

    Time frame: 1 month

    To study CT angiography findings in relation to myocardial infarction shown by CMR

  3. Describe QoL over time

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Swedish Medical Research Council

Registry information

Official study title

Stockholm Myocardial Infarction With Normal Coronaries (SMINC)-2

Acronym: SMINC-2

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Dec 17, 2014
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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