Early Cardiac Magnetic Resonance Imaging in Suspected Non-ST-Elevation Myocardial Infarction (CMR-OBSERVE)
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|ClinicalTrials.gov Identifier: NCT04140019|
Recruitment Status : Recruiting
First Posted : October 25, 2019
Last Update Posted : October 25, 2019
Background and rationale: Evaluating patients with acute chest pain, elevated high-sensitive cardiac troponin (hs-cTn) levels and non-diagnostic electrocardiogram (ECG), i.e. suspected non-ST elevation myocardial infarction (MI), is a daily challenge. Although contemporary hs-cTn assay-based algorithms have greatly facilitated clinical decision-making, still one-quarter of patients is categorized as 'observe' group and in whom a diagnosis initially remains unknown. Although routinely treated as acute (MI) with referral to invasive coronary angiography (ICA), up to one-third does not have obstructive coronary artery disease (CAD). Follow-up cardiac magnetic resonance imaging (CMR) has been shown to be a very useful diagnostic tool in this setting but is not part of routine clinical care in every patient.
Objectives: To investigate in patients with suspected non-ST elevation MI meeting the 'observe' criteria and who are scheduled for ICA: 1) the prevalence of coronary artery disease as well as non-coronary artery disease related and extra-cardiac diseases by adding CMR early in the diagnostic pathway, and 2) the number of major adverse cardiac events (MACE) and a composite of MACE and major (non-cardiac) adverse events after 30 days and one year. These objectives allow an accurate estimate of the number of potentially avoidable ICA in the future and whether early CMR could be a safe gatekeeper for inappropriate ICA.
Study population and design: In this prospective, observational two-center study in The Netherlands (MUMC+ and VieCuri Medical Center), 87 consecutive patients with acute chest pain, non-diagnostic ECG and hs-cTn levels meeting the observe criteria and scheduled for ICA, will be investigated. Patients will undergo a comprehensive CMR examination prior to ICA and will be followed-up at one month and one year. After completion of follow-up, an independent clinical diagnosis committee will adjudicate a final diagnosis: at discharge and after one year. The final diagnosis at discharge will be adjudicated twice: once with and once without considering the results of CMR. For the diagnosis at one-year, all clinical variables and CMR results will be considered. MACE and complications will be scored after 30 days and one year.
Main study parameters/endpoints: The primary endpoint is the prevalence of coronary artery disease as well as non-coronary artery disease related and extra-cardiac diseases. The secondary (safety) endpoint is the number of major adverse cardiac events (MACE) and a composite of MACE and major (non-cardiac) adverse events after 30 days and one year.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
CMR is an accepted and safe imaging modality in patients with (suspected) non-ST-elevation myocardial infarction.
|Condition or disease||Intervention/treatment|
|NSTEMI - Non-ST Segment Elevation MI ACS - Acute Coronary Syndrome||Diagnostic Test: CMR|
|Study Type :||Observational|
|Estimated Enrollment :||87 participants|
|Official Title:||Early Cardiac Magnetic Resonance Imaging in Suspected Non-ST-Elevation Myocardial Infarction: An Observational Two-Center Study|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
Diagnostic Test: CMR
Early CMR with adenosine stress/rest perfusion before invasive coronary angiography.
- Prevalence of coronary artery disease as well as non-coronary artery disease related and extra-cardiac diseases [ Time Frame: Throuhgout study completion, an expected average of one year ]The prevalence of coronary artery disease as well as non-coronary artery disease related and extra-cardiac diseases in patients presenting with acute chest pain, a non-diagnostic ECG and elevated hs-cTn levels meeting the 'observe' criteria by using CMR early in the diagnostic pathway and at least prior to intended invasive coronary angiography
- MACE [ Time Frame: 30 days and one year after inclusion ]The number of MACE after 30 days and one year
- Composite of MACE and major (non-cardiac) adverse events [ Time Frame: 30 days and one year after inclusion ]The number of a composite of MACE and major (non-cardiac) adverse events after 30 days and one year.
- Diagnostic accuracy of CMR for the diagnosis of obstructive CAD. [ Time Frame: One year after inclusion ]The diagnostic accuracy of CMR for the diagnosis of obstructive CAD (i.e. stenosis ≥70%) by means of specificity and sensitivity.
Biospecimen Retention: Samples With DNA
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): NCT04140019
|Contact: Sebastiaan Bekkers, MD PhDfirstname.lastname@example.org|
|Contact: Geertruida Bijvoet, MDemail@example.com|
|Contact: Sebastiaan Bekkers, MD, PhD|