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Early Cardiac Magnetic Resonance Imaging in Suspected Non-ST-Elevation Myocardial Infarction (CMR-OBSERVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04140019
Recruitment Status : Recruiting
First Posted : October 25, 2019
Last Update Posted : October 25, 2019
Sponsor:
Collaborator:
VieCuri Medical Centre
Information provided by (Responsible Party):
Maastricht University Medical Center

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.


Condition or disease Intervention/treatment
NSTEMI - Non-ST Segment Elevation MI ACS - Acute Coronary Syndrome Diagnostic Test: CMR

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Study Type : Observational
Estimated Enrollment : 87 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
NSTEMI Diagnostic Test: CMR
Early CMR with adenosine stress/rest perfusion before invasive coronary angiography.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. MACE [ Time Frame: 30 days and one year after inclusion ]
    The number of MACE after 30 days and one year

  2. 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.

  3. 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
Blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Pregnancy
  • Breast feeding women
  • Life expectancy <1 year (malignancy, etc.)
  • Refusal of data storage until 15 years after end of study
  • Participation in another investigational study that has not reached its primary endpoint
  • Contraindications to CMR:

ODIN-protocol: "Uitvoering van MRI-onderzoek bij patiënten met een cardiaal implanteerbaar elektronisch device (CIED), waaronder een pacemaker en ICD"; ODIN-protocol: "Voorbereiding klinische patiënten voor MRI-onderzoek"

  • Metallic implant (vascular clip, neuro-stimulator, cochlear implant)
  • Pacemaker or implantable cardiac defibrillator (ICD)
  • Claustrophobia
  • Body weight >130 kg or body habitus that does not fit into the gantry
  • Renal failure (estimated Glomerular Filtration Rate (eGFR) ≤30 mL/min/1,73m2) / chronic renal failure stage 4-5
  • Known severe allergy to gadolinium contrast agents (patient with mild allergy is eligible for inclusion when pre-medication according to hospital guidelines can be administered)

    • Contraindications to adenosine:

  • High degree atrio-ventricular block (2nd or 3rd degree)
  • Severe bronchial asthma
  • Chronic obstructive pulmonary disease GOLD >=III
  • Concomitant use of Dipyridamole (Persantin®)
  • Long QT syndrome (congenital)

Information from the National Library of Medicine

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


Contacts
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Contact: Sebastiaan Bekkers, MD PhD 0031-43-3877097 s.bekkers@mumc.nl
Contact: Geertruida Bijvoet, MD 0031-43-3867416 miranda.bijvoet@mumc.nl

Locations
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Netherlands
Maastricht UMC Recruiting
Maastricht, Netherlands
Contact: Sebastiaan Bekkers, MD, PhD         
Sponsors and Collaborators
Maastricht University Medical Center
VieCuri Medical Centre
Publications:

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT04140019    
Other Study ID Numbers: NL65125.068.18
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht University Medical Center:
NSTEMI
NSTE-ACS
CMR
Troponin T
Cardiac Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
Non-ST Elevated Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases