The Supplementary Role of Non-invasive Imaging to Routine Clinical Practice in Suspected Non-ST-elevation Myocardial Infarction

Study Overview
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Brief Summary
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Approximately half of patients with acute chest pain, a very common reason for emergency department visits worldwide, have a cardiac cause. Two-thirds of patients with a cardiac cause are eventually diagnosed with a so-called non-ST-elevation myocardial infarction. The diagnosis of non-ST-elevation myocardial infarction is based on a combination of symptoms, electrocardiographic changes, and increased serum cardiac specific biomarkers (high-sensitive troponin T). Although being very sensitive of myocardial injury, increased high-sensitive troponin T levels are not specific for myocardial infarction. Invasive coronary angiography is still the reference standard for coronary imaging in suspected non-ST-elevation myocardial infarction. This study investigates whether non-invasive imaging early in the diagnostic process (computed tomography angiography (CTA) or cardiovascular magnetic resonance imaging (CMR)) can prevent unnecessary invasive coronary angiography. For this, patients will be randomly assigned to either one of three strategies: 1) routine clinical care and computed tomography angiography early in the diagnostic process, 2) routine clinical care and cardiovascular magnetic resonance imaging early in the diagnostic process, or 3) routine clinical care without non-invasive imaging early in the diagnostic process.

Official Title
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The Supplementary Role of Cardiovascular Magnetic Resonance Imaging and Computed Tomography Angiography to Routine Clinical Practice in Suspected Non-ST Elevation Myocardial Infarction - A Randomized Controlled Trial

Conditions
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Chest Pain, Myocardial Infarction, Acute Coronary Syndrome, Coronary Artery Disease, Myocardial Ischemia

Intervention / Treatment
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* Other: Cardiovascular Magnetic Resonance Imaging
* Other: Computed Tomography Angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prolonged symptoms suspected of cardiac origin (angina pectoris or angina equivalent), and presentation on the cardiac emergency department <24 hours after symptom onset Increased levels of high-sensitive Troponin-T (>14ng/L) Age >18 years and <85 years Willing and capable to give written informed consent Written informed consent Exclusion Criteria: Ongoing severe ischemia requiring immediate invasive coronary angiography Shock (mean arterial pressure < 60 mmHg) or severe heart failure (Killip Class ≥ III) 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) Chest pain highly suggestive of non-cardiac origin: Acute aortic dissection Acute pulmonary embolism (high risk patient defined as Wells score >6) Musculoskeletal or gastro-intestinal pain Other (pneumothorax, pneumonia, rib fracture, etc.) Previously known coronary artery disease, defined as: Any non-invasive diagnostic imaging test positive for coronary artery disease Coronary stenosis >50% on any previous invasive coronary angiography or computed tomography angiography Documented previous myocardial infarction Documented previous coronary artery revascularization Known cardiomyopathy Pregnancy Life threatening arrhythmia on the cardiac emergency department or prior to presentation Tachycardia (≥100/bpm) Atrial fibrillation Angina pectoris secondary to anemia (<5.6 mmol/L), untreated hyperthyroidism, aortic valve stenosis (aortic valve area ≤ 1.5 cm2), or severe hypertension (>200/110 mmHg) Life expectancy <1 year (malignancy, etc.) Contraindications to cardiovascular magnetic resonance imaging: metallic implant (vascular clip, neuro-stimulator, cochlear implant), pacemaker or implantable cardiac defibrillator, claustrophobia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Routine clinical care plus early CMR<br> | Other: Cardiovascular Magnetic Resonance Imaging<br>* Routine clinical care plus cardiovascular magnetic resonance imaging early in the diagnostic process<br>|
| No Intervention: Routine clinical care<br> | |
| Other: Routine clinical care plus early CTA<br> | Other: Computed Tomography Angiography<br>* Routine clinical care plus computed tomography angiography early in the diagnostic process<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of patients with at least one invasive coronary angiography during initial admission |  | During initial hospital admission, an expected average of 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thirty-day clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications) |  | 30 days | 
| One-year clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications) |  | One-year | 
| Quality of life |  | One-year | 
| Cost-effectiveness | The economic evaluation will be a cost-effectiveness analysis, with quality-adjusted life years (QALYs) as outcome measure. Effects will be calculated in terms of QALYs. To investigate the cost-effectiveness of the three strategies, incremental cost-effectiveness ratios (ICERs) will be calculated. Cost-effectiveness acceptability curves (CEACs) are derived in order to show the probability of each strategy being the optimal choice, for a range of possible maximum values a decision maker is willing to pay for a QALY. | After study completion, expected after 3 years | 
| Cardiogoniometry | A retrospective analysis will be performed to investigate whether CGM performed on the cardiac emergency department can differentiate between a coronary and non-coronary etiology in suspected NSTEMI | After study completion, expected after 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial infarction, Randomized Controlled Trial, Magnetic Resonance Imaging, Coronary Angiography, Tomography, X-Ray Computed, Mortality, Complications, Quality of Life, Cost-Benefit Analysis