Clinical trial NCT02318498: Stockholm Myocardial Infarction With Normal Coronaries (SMINC)-2 Study on Diagnosis Made by Cardiac MRI
Official title: Stockholm Myocardial Infarction With Normal Coronaries (SMINC)-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Swedish Medical Research Council
First posted: 2014-12-17
Enrollment: 150
Sex: ALL
Minimum age (years): 35
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

Eligibility 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

Primary outcomes:
measure: Diagnostic accuracy of an early CMR with the latest technique
timeFrame: 2-4 days after admission
Secondary outcomes:
measure: Number of patients with correct diagnosis with echocardiography
timeFrame: 12 months
measure: Number of patients with a postive CT angiography and infarction on CMR
timeFrame: 1 month
measure: Describe QoL over time
timeFrame: 12 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Per Tornvall, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sorensson P, Ekenback C, Lundin M, Agewall S, Bacsovics Brolin E, Caidahl K, Cederlund K, Collste O, Daniel M, Jensen J, Y-Hassan S, Henareh L, Hofman-Bang C, Lynga P, Maret E, Sarkar N, Spaak J, Winnberg O, Ugander M, Tornvall P. Early Comprehensive Cardiovascular Magnetic Resonance Imaging in Patients With Myocardial Infarction With Nonobstructive Coronary Arteries. JACC Cardiovasc Imaging. 2021 Sep;14(9):1774-1783. doi: 10.1016/j.jcmg.2021.02.021. Epub 2021 Apr 14.
citation: Tornvall P, Brolin EB, Caidahl K, Cederlund K, Collste O, Daniel M, Ekenback C, Jensen J, Y-Hassan S, Henareh L, Hofman-Bang C, Lynga P, Maret E, Sarkar N, Spaak J, Sundqvist M, Sorensson P, Ugander M, Agewall S. The value of a new cardiac magnetic resonance imaging protocol in Myocardial Infarction with Non-obstructive Coronary Arteries (MINOCA) - a case-control study using historical controls from a previous study with similar inclusion criteria. BMC Cardiovasc Disord. 2017 Jul 24;17(1):199. doi: 10.1186/s12872-017-0611-5.