NSTEMI - Non-ST Segment Elevation MI Clinical Trial
— CMR-OBSERVEOfficial title:
Early Cardiac Magnetic Resonance Imaging in Suspected Non-ST-Elevation Myocardial Infarction: An Observational Two-Center Study
NCT number | NCT04140019 |
Other study ID # | NL65125.068.18 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2018 |
Est. completion date | March 2024 |
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.
Status | Recruiting |
Enrollment | 87 |
Est. completion date | March 2024 |
Est. primary completion date | March 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht UMC | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center | VieCuri Medical Centre |
Netherlands,
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* Note: There are 31 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | MACE | The number of MACE after 30 days and one year | 30 days and one year after inclusion | |
Secondary | Composite of MACE and major (non-cardiac) adverse events | The number of a composite of MACE and major (non-cardiac) adverse events after 30 days and one year. | 30 days and one year after inclusion | |
Secondary | Diagnostic accuracy of CMR for the diagnosis of obstructive CAD. | The diagnostic accuracy of CMR for the diagnosis of obstructive CAD (i.e. stenosis =70%) by means of specificity and sensitivity. | One year after inclusion |
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