Overview

This trial is active, not recruiting.

Conditions chest pain, myocardial infarction, acute coronary syndrome, coronary artery disease, myocardial ischemia
Treatments cardiovascular magnetic resonance imaging, computed tomography angiography
Sponsor Maastricht University Medical Center
Collaborator Dutch Heart Foundation
Start date April 2012
End date May 2017
Trial size 300 participants
Trial identifier NCT01559467, NL37574.068.11 / METC 11-2-077

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Other)
cardiovascular magnetic resonance imaging
Routine clinical care plus cardiovascular magnetic resonance imaging early in the diagnostic process
(No Intervention)
(Other)
computed tomography angiography
Routine clinical care plus computed tomography angiography early in the diagnostic process

Primary Outcomes

Measure
Total number of patients with at least one invasive coronary angiography during initial admission
time frame: During initial hospital admission, an expected average of 7 days

Secondary Outcomes

Measure
Thirty-day clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications)
time frame: 30 days
One-year clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications)
time frame: One-year
Quality of life
time frame: One-year
Cost-effectiveness
time frame: After study completion, expected after 3 years
Cardiogoniometry
time frame: After study completion, expected after 3 years

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title 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
Principal investigator Harry J Crijns, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Maastricht University Medical Center.