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

NCT02318498 | Completed

• 1 other identifier: 2
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of an early CMR with the latest technique

  Show that the more patients get a definite diagnosis (70%) when compared to a historical sample (50%)

  2-4 days after admission

Secondary Outcomes (3)

• Number of patients with correct diagnosis with echocardiography

  12 months

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

  1 month

• Describe QoL over time

  12 months

Study Arms (2)

Prospective MINCA patients

ACTIVE COMPARATOR

Patients with MINCA prospectively investigated with an early CMR with latest technique

Procedure: CMR

Historical MINCA patients

PLACEBO COMPARATOR

Patients with MINCA investigated earlier with a late CMR (median 12 days)

Procedure: CMR

Interventions

CMR PROCEDURE

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

Historical MINCA patients; Prospective MINCA patients

Eligibility Criteria

• Age: 35 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years
• Fullfill the diagnosic criteria of myocardial infarction
• Normal coronary angiography or minor atheromatosis
• Sinus rythm on ECG at admission

You may not qualify if:

• Previous myocardial infarction
• Known cardiomyopathy
• Pacemaker or claustrophobia
• Severe chronic obstructive lung or kidney disease
• Pulmonary embolism

Sponsors & Collaborators

• Karolinska Institutet: lead
• Swedish Medical Research Council: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

Related Publications (5)

• Steffen Johansson R, Tornvall P, Sorensson P, Nickander J. Reduced stress perfusion in myocardial infarction with nonobstructive coronary arteries. Sci Rep. 2023 Dec 13;13(1):22094. doi: 10.1038/s41598-023-49223-w.

  PMID: 38086910 DERIVED

• Sundqvist MG, Sorensson P, Ekenback C, Lundin M, Agewall S, Brolin EB, 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, Caidahl K, Ugander M, Tornvall P. CMR Is Often Abnormal Despite Normal Echocardiography in Suspected Myocardial Infarction With Nonobstructed Coronary Arteries. JACC Cardiovasc Imaging. 2023 Dec;16(12):1626-1628. doi: 10.1016/j.jcmg.2023.05.024. Epub 2023 Jul 26. No abstract available.

  PMID: 37498255 DERIVED

• Berg E, Agewall S, Brolin EB, Caidahl K, Cederlund K, Collste O, Daniel M, Ekenback C, Jensen J, Y-Hassan S, Henareh L, Maret E, Spaak J, Sorensson P, Tornvall P, Lynga P. Health-related quality-of-life up to one year after myocardial infarction with non-obstructive coronary arteries. Eur Heart J Qual Care Clin Outcomes. 2023 Sep 12;9(6):639-644. doi: 10.1093/ehjqcco/qcac072.

  PMID: 36328780 DERIVED

• 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.

  PMID: 33865778 DERIVED

• 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.

  PMID: 28738781 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

• Per Tornvall, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 17, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2018
• Study Completion: April 1, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

SE (1)