Clinical trial NCT01559467: The Supplementary Role of Non-invasive Imaging to Routine Clinical Practice in Suspected Non-ST-elevation Myocardial Infarction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pain
Myocardial Infarction
Acute Coronary Syndrome
Coronary Artery Disease
Myocardial Ischemia
Keywords: Myocardial infarction
Randomized Controlled Trial
Magnetic Resonance Imaging
Coronary Angiography
Tomography, X-Ray Computed
Mortality
Complications
Quality of Life
Cost-Benefit Analysis
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Heart Foundation
First posted: 2012-03-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Total number of patients with at least one invasive coronary angiography during initial admission
timeFrame: 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)
timeFrame: 30 days
measure: One-year clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications)
timeFrame: One-year
measure: Quality of life
timeFrame: One-year
measure: Cost-effectiveness
timeFrame: After study completion, expected after 3 years
measure: Cardiogoniometry
timeFrame: After study completion, expected after 3 years
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Harry J Crijns, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Joachim Wildberger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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