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
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04140019
|Contact: Sebastiaan Bekkers, MD PhDemail@example.com|
|Contact: Geertruida Bijvoet, MDfirstname.lastname@example.org|
|Contact: Sebastiaan Bekkers, MD, PhD|