ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01559467
Recruitment Status : Completed
First Posted : March 21, 2012
Last Update Posted : July 5, 2017
Sponsor:
Collaborator:
Dutch Heart Foundation
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Chest Pain Myocardial Infarction Acute Coronary Syndrome Coronary Artery Disease Myocardial Ischemia Other: Cardiovascular Magnetic Resonance Imaging Other: Computed Tomography Angiography Not Applicable

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2012
Actual Primary Completion Date : May 2017
Actual Study Completion Date : June 19, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559467


Locations
Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6202 AZ
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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
First Posted: March 21, 2012    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 2016

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:
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Ischemia
Acute Coronary Syndrome
Chest Pain
Non-ST Elevated Myocardial Infarction
Pathologic Processes
 Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms