Stockholm Myocardial Infarction With Normal Coronaries (SMINC)-2 Study on Diagnosis Made by Cardiac MRI (SMINC-2)
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
CMR
Sponsored by
About this trial
This is an interventional diagnostic trial for Myocardial Infarction
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
Sites / Locations
- Karolinska Institutet
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Prospective MINCA patients
Historical MINCA patients
Arm Description
Patients with MINCA prospectively investigated with an early CMR with latest technique
Patients with MINCA investigated earlier with a late CMR (median 12 days)
Outcomes
Primary Outcome Measures
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%)
Secondary Outcome Measures
Number of patients with correct diagnosis with echocardiography
To study the accuracy of echocardiography compared to CMR using ROC
Number of patients with a postive CT angiography and infarction on CMR
To study CT angiography findings in relation to myocardial infarction shown by CMR
Describe QoL over time
Full Information
NCT ID
NCT02318498
First Posted
December 5, 2014
Last Updated
September 4, 2019
Sponsor
Karolinska Institutet
Collaborators
Swedish Medical Research Council
1. Study Identification
Unique Protocol Identification Number
NCT02318498
Brief Title
Stockholm Myocardial Infarction With Normal Coronaries (SMINC)-2 Study on Diagnosis Made by Cardiac MRI
Acronym
SMINC-2
Official Title
Stockholm Myocardial Infarction With Normal Coronaries (SMINC)-2
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
April 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Swedish Medical Research Council
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prospective MINCA patients
Arm Type
Active Comparator
Arm Description
Patients with MINCA prospectively investigated with an early CMR with latest technique
Arm Title
Historical MINCA patients
Arm Type
Placebo Comparator
Arm Description
Patients with MINCA investigated earlier with a late CMR (median 12 days)
Intervention Type
Procedure
Intervention Name(s)
CMR
Intervention Description
Intervention performed 2-4 days after admission to hospital with the latest CMR technique including sensitive oedema sequences using T1 mapping
Primary Outcome Measure Information:
Title
Diagnostic accuracy of an early CMR with the latest technique
Description
Show that the more patients get a definite diagnosis (70%) when compared to a historical sample (50%)
Time Frame
2-4 days after admission
Secondary Outcome Measure Information:
Title
Number of patients with correct diagnosis with echocardiography
Description
To study the accuracy of echocardiography compared to CMR using ROC
Time Frame
12 months
Title
Number of patients with a postive CT angiography and infarction on CMR
Description
To study CT angiography findings in relation to myocardial infarction shown by CMR
Time Frame
1 month
Title
Describe QoL over time
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Tornvall, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
33865778
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.
Results Reference
derived
PubMed Identifier
28738781
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.
Results Reference
derived
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Stockholm Myocardial Infarction With Normal Coronaries (SMINC)-2 Study on Diagnosis Made by Cardiac MRI
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