Early Cardiac Magnetic Resonance Imaging in Suspected Non-ST-Elevation Myocardial Infarction

Summary

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.

Conditions

• NSTEMI - Non-ST Segment Elevation MI
• ACS - Acute Coronary Syndrome

Interventions

DIAGNOSTIC_TEST

CMR

Early CMR with adenosine stress/rest perfusion before invasive coronary angiography.

Sponsors & Collaborators

• VieCuri Medical Centre

  collaborator OTHER

• Maastricht University Medical Center

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-10-01

Primary Completion

2023-03-31

Completion

2024-03-31

Countries

• Netherlands

Study Locations