The Supplementary Role of Non-invasive Imaging to Routine Clinical Practice in Suspected Non-ST-elevation Myocardial Infarction (CARMENTA)
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ClinicalTrials.gov Identifier: NCT01559467 |
Recruitment Status
:
Completed
First Posted
: March 21, 2012
Last Update Posted
: July 5, 2017
|
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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 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 |
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
|
- 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 ]
- Thirty-day clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications) [ Time Frame: 30 days ]
- One-year clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications) [ Time Frame: One-year ]
- Quality of life [ Time Frame: One-year ]
- 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.
- 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

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Netherlands | |
Maastricht University Medical Center | |
Maastricht, Limburg, Netherlands, 6202 AZ |
Principal Investigator: | Harry J Crijns, MD, PhD | Maastricht University Medical Center | |
Principal Investigator: | Joachim Wildberger, MD, PhD | Maastricht University Medical Center |
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 |