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.
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
  Purpose

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.


Condition Intervention
Chest Pain
Myocardial Infarction
Acute Coronary Syndrome
Coronary Artery Disease
Myocardial Ischemia
Other: Cardiovascular Magnetic Resonance Imaging
Other: Computed Tomography Angiography

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 300
Study Start Date: April 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Routine clinical care plus early CMR Other: Cardiovascular Magnetic Resonance Imaging
Routine clinical care plus cardiovascular magnetic resonance imaging early in the diagnostic process
No Intervention: Routine clinical care
Routine clinical care plus early CTA Other: Computed Tomography Angiography
Routine clinical care plus computed tomography angiography early in the diagnostic process

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559467

Contacts
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

Locations
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Limburg, Netherlands, 6202 AZ
Contact: Sebastiaan C Bekkers, MD, PhD    +31-43-3875098    s.bekkers@mumc.nl   
Contact: Bas Kietselaer, MD, PhD    +31-43-3875093    b.kietselaer@mumc.nl   
Principal Investigator: Harry J Crijns, MD, PhD         
Principal Investigator: Joachim Wildberger, MD, PhD         
Sub-Investigator: Sebastiaan C Bekkers, MD, PhD         
Sub-Investigator: Bas Kietselaer, MD, PhD         
Sponsors and Collaborators
Maastricht University Medical Center
Dutch Heart Foundation
Investigators
Principal Investigator: Harry J Crijns, MD, PhD Maastricht University Medical Center
Principal Investigator: Joachim Wildberger, MD, PhD Maastricht University Medical Center
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01559467     History of Changes
Other Study ID Numbers: NL37574.068.11 / METC 11-2-077
Study First Received: March 12, 2012
Last Updated: May 2, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Myocardial infarction
Randomized Controlled Trial
Magnetic Resonance Imaging
Coronary Angiography
Tomography, X-Ray Computed
Mortality
Complications
Quality of Life
Cost-Benefit Analysis

Additional relevant MeSH terms:
Chest Pain
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Ischemia
Myocardial Infarction
Acute Coronary Syndrome
Pain
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Necrosis
Angina Pectoris

ClinicalTrials.gov processed this record on April 17, 2014