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

September 4, 2019 updated by: Per Tornvall, Karolinska Institutet

Stockholm Myocardial Infarction With Normal Coronaries (SMINC)-2

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%)
2-4 days after admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with correct diagnosis with echocardiography
Time Frame: 12 months
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
Time Frame: 1 month
To study CT angiography findings in relation to myocardial infarction shown by CMR
1 month
Describe QoL over time
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Swedish Medical Research Council

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2014

Primary Completion (ACTUAL)

November 1, 2018

Study Completion (ACTUAL)

April 1, 2019

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

December 12, 2014

First Posted (ESTIMATE)

December 17, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 4, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2 (Other Identifier: Instituto Cardiovascular de Buenos Aires)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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