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

Primary Purpose

Chest Pain, Myocardial Infarction, Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Cardiovascular Magnetic Resonance Imaging
Computed Tomography Angiography
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chest Pain focused on measuring Myocardial infarction, Randomized Controlled Trial, Magnetic Resonance Imaging, Coronary Angiography, Tomography, X-Ray Computed, Mortality, Complications, Quality of Life, Cost-Benefit Analysis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

No Intervention

Other

Arm Label

Routine clinical care plus early CMR

Routine clinical care

Routine clinical care plus early CTA

Arm Description

Outcomes

Primary Outcome Measures

Total number of patients with at least one invasive coronary angiography during initial admission

Secondary Outcome Measures

Thirty-day clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications)
One-year clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications)
Quality of life
Cost-effectiveness
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
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

Full Information

First Posted
March 12, 2012
Last Updated
July 3, 2017
Sponsor
Maastricht University Medical Center
Collaborators
Dutch Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01559467
Brief Title
The Supplementary Role of Non-invasive Imaging to Routine Clinical Practice in Suspected Non-ST-elevation Myocardial Infarction
Acronym
CARMENTA
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 Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
June 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Dutch Heart Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Myocardial Infarction, Acute Coronary Syndrome, Coronary Artery Disease, Myocardial Ischemia
Keywords
Myocardial infarction, Randomized Controlled Trial, Magnetic Resonance Imaging, Coronary Angiography, Tomography, X-Ray Computed, Mortality, Complications, Quality of Life, Cost-Benefit Analysis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine clinical care plus early CMR
Arm Type
Other
Arm Title
Routine clinical care
Arm Type
No Intervention
Arm Title
Routine clinical care plus early CTA
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Cardiovascular Magnetic Resonance Imaging
Intervention Description
Routine clinical care plus cardiovascular magnetic resonance imaging early in the diagnostic process
Intervention Type
Other
Intervention Name(s)
Computed Tomography Angiography
Intervention Description
Routine clinical care plus computed tomography angiography early in the diagnostic process
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Thirty-day clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications)
Time Frame
30 days
Title
One-year clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications)
Time Frame
One-year
Title
Quality of life
Time Frame
One-year
Title
Cost-effectiveness
Description
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.
Time Frame
After study completion, expected after 3 years
Title
Cardiogoniometry
Description
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
Time Frame
After study completion, expected after 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry J Crijns, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joachim Wildberger, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202 AZ
Country
Netherlands

12. IPD Sharing Statement

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

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