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

NCT ID: NCT01559467

Last Updated: 2017-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2017-06-19

Brief Summary

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.

Conditions

Chest Pain; Myocardial Infarction; Acute Coronary Syndrome; Coronary Artery Disease; Myocardial Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Routine clinical care plus early CMR

Group Type: OTHER

Cardiovascular Magnetic Resonance Imaging

Intervention Type: OTHER

Routine clinical care plus cardiovascular magnetic resonance imaging early in the diagnostic process

Routine clinical care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Routine clinical care plus early CTA

Group Type: OTHER

Computed Tomography Angiography

Intervention Type: OTHER

Routine clinical care plus computed tomography angiography early in the diagnostic process

Interventions

Cardiovascular Magnetic Resonance Imaging

Routine clinical care plus cardiovascular magnetic resonance imaging early in the diagnostic process

Intervention Type: OTHER

Computed Tomography Angiography

Routine clinical care plus computed tomography angiography early in the diagnostic process

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dutch Heart Foundation

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harry J Crijns, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Joachim Wildberger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Countries

Netherlands

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Other Identifiers

NL37574.068.11 / METC 11-2-077

Identifier Type: -

Identifier Source: org_study_id