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

Stockholm Myocardial Infarction With Normal Coronaries (SMINC)-2

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02318498
Acronym
SMINC-2
Enrollment
150
Registered
2014-12-17
Start date
2014-11-30
Completion date
2019-04-30
Last updated
2019-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

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.

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).

Interventions

PROCEDURECMR

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

Sponsors

Swedish Medical Research Council
CollaboratorUNKNOWN
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
35 Years to 69 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of an early CMR with the latest technique2-4 days after admissionShow that the more patients get a definite diagnosis (70%) when compared to a historical sample (50%)

Secondary

MeasureTime frameDescription
Number of patients with correct diagnosis with echocardiography12 monthsTo study the accuracy of echocardiography compared to CMR using ROC
Number of patients with a postive CT angiography and infarction on CMR1 monthTo study CT angiography findings in relation to myocardial infarction shown by CMR
Describe QoL over time12 months

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026