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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Maastricht University Medical Center
Sponsor:
Collaborator:
Dutch Heart Foundation
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01559467
First received: March 12, 2012
Last updated: May 2, 2013
Last verified: May 2013

March 12, 2012
May 2, 2013
April 2012
April 2015   (final data collection date for primary outcome 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01559467 on ClinicalTrials.gov Archive Site
  • Thirty-day clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • One-year clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications) [ Time Frame: One-year ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: One-year ] [ Designated as safety issue: No ]
  • Cost-effectiveness [ Time Frame: After study completion, expected after 3 years ] [ Designated as safety issue: No ]
    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.
  • Cardiogoniometry [ Time Frame: After study completion, expected after 3 years ] [ Designated as safety issue: No ]
    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
  • Thirty-day clinical outcome (major adverse cardiac events) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Composite of one-year clinical outcome (major adverse cardiac events) and major adverse events [ Time Frame: One-year ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: One-year ] [ Designated as safety issue: No ]
  • Cost-effectiveness [ Time Frame: After study completion, expected after 3 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Supplementary Role of Non-invasive Imaging to Routine Clinical Practice in Suspected Non-ST-elevation Myocardial Infarction
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Chest Pain
  • Myocardial Infarction
  • Acute Coronary Syndrome
  • Coronary Artery Disease
  • Myocardial Ischemia
  • Other: Cardiovascular Magnetic Resonance Imaging
    Routine clinical care plus cardiovascular magnetic resonance imaging early in the diagnostic process
  • Other: Computed Tomography Angiography
    Routine clinical care plus computed tomography angiography early in the diagnostic process
  • Routine clinical care plus early CMR
    Intervention: Other: Cardiovascular Magnetic Resonance Imaging
  • No Intervention: Routine clinical care
  • Routine clinical care plus early CTA
    Intervention: Other: Computed Tomography Angiography

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
April 2015
April 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Martijn W Smulders, MD +31-43-3875098 martijn.smulders@mumc.nl
Contact: Sebastiaan C Bekkers, MD, PhD +31-43-3875098 s.bekkers@mumc.nl
Netherlands
 
NCT01559467
NL37574.068.11 / METC 11-2-077
No
Maastricht University Medical Center
Maastricht University Medical Center
Dutch Heart Foundation
Principal Investigator: Harry J Crijns, MD, PhD Maastricht University Medical Center
Principal Investigator: Joachim Wildberger, MD, PhD Maastricht University Medical Center
Maastricht University Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP