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

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ClinicalTrials.gov Identifier: NCT02318498
Recruitment Status : Completed
First Posted : December 17, 2014
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
Swedish Medical Research Council
Information provided by (Responsible Party):
Per Tornvall, 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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Procedure: CMR Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Stockholm Myocardial Infarction With Normal Coronaries (SMINC)-2
Actual Study Start Date : November 2014
Actual Primary Completion Date : November 2018
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02318498


Locations
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Sweden
Karolinska Institutet
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
Swedish Medical Research Council
Investigators
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Principal Investigator: Per Tornvall, MD, PhD Karolinska Institutet
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Per Tornvall, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02318498    
Other Study ID Numbers: 2
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases