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

NCT04140019 | Unknown

• 1 other identifier: NL65125.068.18
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

NSTEMI; NSTE-ACS; CMR; Troponin T; Cardiac Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Prevalence of coronary artery disease as well as non-coronary artery disease related and extra-cardiac diseases

  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

  Throuhgout study completion, an expected average of one year

Secondary Outcomes (3)

• MACE

  30 days and one year after inclusion

• Composite of MACE and major (non-cardiac) adverse events

  30 days and one year after inclusion

• Diagnostic accuracy of CMR for the diagnosis of obstructive CAD.

  One year after inclusion

Study Arms (1)

NSTEMI

Diagnostic Test: CMR

Interventions

CMR DIAGNOSTIC_TEST

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

NSTEMI

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting to the cardiac ED with acute chest pain, a non-diagnostic ERCG, elevated hs-cTn levels meeting the 'observe' criteria, and who are admitted and scheduled for an ICA, will be eligible to participate in this study.

You may qualify if:

• Acute onset (\>1 hour) chest pain (or angina pectoris equivalent) suspected of non-ST-elevation myocardial infarction (NSTEMI)
• Hospital admission and scheduling for ICA
• Hs-cTn levels meeting the 'observe' criteria (figure 2, p17)
• Age between 18 years - 85 years old
• Written informed consent

You may not qualify if:

• Refractory angina or on-going severe ischemia requiring immediate ICA
• Patients requiring ICA \< 24 hours after admission (see previous bullet)
• Hemodynamic instability and/or cardiogenic shock (mean arterial pressure \<60 mmHg)
• Heart failure (Killip Class ≥ III) requiring intravenously medication (nitroglycerine, diuretics, etc.)
• ST-Elevation Myocardial Infarction (ST-elevation in 2 contiguous leads: ≥0.2mV in men or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads or new left bundle branch block)
• Symptoms highly suggestive of non-cardiac origin at presentation (as judged by the cardiac ED physician/cardiologist)
• Symptoms highly suggestive of AAD, PE, or acute peri-myocarditis
• Inability to organize ICA and CMR \<72 hours after admission (especially for patients admitted on Friday evenings/nights (logistic restrictions).
• Life threatening arrhythmias prior to or during presentation (sustained ventricular tachycardia, repetitive non-sustained ventricular tachycardia, ventricular fibrillation, sinoatrial or atrio-ventricular block)
• Atrial fibrillation with persistent ventricular rate ≥100 beats per minute (bpm) after treatment
• Ongoing tachycardia (≥100/bpm)
• Angina pectoris secondary to anemia (\<5.6 mmol/L), untreated hyperthyroidism, or severe hypertension (\>200/110 mmHg)
• More than mild aortic and mitral valve calcification or stenosis by latest echocardiography
• Recent revascularization or ACUTE MI (\<6 months)
• Known CAD not suitable for further interventions (PCI or CABG)

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• VieCuri Medical Centre: collaborator

Study Sites (1)

Maastricht UMC

Maastricht, Netherlands

RECRUITING

Related Publications (31)

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Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Sebastiaan Bekkers, MD PhD

CONTACT

0031-43-3877097; s.bekkers@mumc.nl

Geertruida Bijvoet, MD

CONTACT

0031-43-3867416; miranda.bijvoet@mumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: October 25, 2019
• Study Start: October 1, 2018
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2024
• Last Updated: October 4, 2021

Record last verified: 2021-09

Locations

NL (1)