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NCT Number: NCT01559467

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

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.

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Key information

Conditions

Chest Pain Acute Coronary Syndrome Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6202 AZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiovascular Magnetic Resonance Imaging

Other

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

Computed Tomography Angiography

Other

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

Primary outcomes

  1. 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

  1. Thirty-day clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications)

    Time frame: 30 days

  2. One-year clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications)

    Time frame: One-year

  3. Quality of life

    Time frame: One-year

  4. Cost-effectiveness

    Time frame: After study completion, expected after 3 years

    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.

  5. Cardiogoniometry

    Time frame: After study completion, expected after 3 years

    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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Dutch Heart Foundation

Registry information

Official study 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

Acronym: CARMENTA

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Mar 21, 2012
Registry last updated
Jul 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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