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

July 3, 2017 updated by: Maastricht University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6202 AZ
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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
OTHER: Routine clinical care plus early CTA
Other: Computed Tomography Angiography
Routine clinical care plus computed tomography angiography early in the diagnostic process

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
During initial hospital admission, an expected average of 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thirty-day clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications)
Time Frame: 30 days
30 days
One-year clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications)
Time Frame: One-year
One-year
Quality of life
Time Frame: One-year
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.
After study completion, expected after 3 years
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
After study completion, expected after 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Dutch Heart Foundation

Investigators

  • Principal Investigator: Harry J Crijns, MD, PhD, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

June 19, 2017

Study Registration Dates

First Submitted

March 12, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (ESTIMATE)

March 21, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2017

Last Update Submitted That Met QC Criteria

July 3, 2017

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL37574.068.11 / METC 11-2-077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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