- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02360150
Evaluation of Myocardial Viability : Dual Energy Cardiac CT vs. Cardiac MRI (InfarctusGSI)
Evaluation of Myocardial Viability in Late Presentation Myocardial Infarction: Dual Energy Cardiac CT vs. Cardiac MRI.
The purpose of this study is therefore to show that associated with cardiac angiography echocardiography, in myocardial seen late, would provide the information necessary for the decision revascularization, in a timely manner.
This would allow the patient to avoid duplication of tests including risk related to coronary angiography (bleeding complications, stroke ...) and those related to the implantation of coronary stent (stent) without expected earnings in case of non-viability . This would also reduce the length of hospital stay and costs due to numerous reviews.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Percutaneous coronary intervention is not recommended in stable patients with late presentation myocardial infarction, and myocardial viability needs to be evaluated before the procedure. The aim of the study is to evaluate the sensibility and specificity of dual-energy CT for the evaluation of myocardial viability in comparison to cardiac MRI.
The experimental procedure is limited to a second CT acquisition performed 10 minutes in dual energy mode.
Sensitivity and Specificity of delayed enhancement >50% of myocardial thickness provided by dual-energy CT will be evaluated in comparison to cardiac MRI.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Normandy
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Rouen, Normandy, France, 76031
- University Hospital of Rouen
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Man or woman
- Major patient
- Patient with electrical, biological and clinical signs of myocardial infarction, with late presentation (>24 hours)
- Creatinine clearance (calculated using the Cockcroft (<age 65) or MDRD (> 65 years))formula > 30 ml / min.
- Affiliation to the french social security scheme.
- Women of childbearing age: Negative pregnancy test (urine test).
- Postmenopausal women, menopause confirmation of diagnosis
- Patient able to understand the spoken and written French.
- Signature of informed consent
Exclusion Criteria:
- Collapsus or organ failure requiring urgent care in intensive care unit
- Arrhythmia and/or non-reducible tachycardia.
- History of allergic reaction after iodinated contrast medium injection.
- History of nephrogenic systemic fibrosis.
- History of claustrophobia
- Unbalanced asthma.
- Acute pulmonary edema.
- Pregnant or breastfeeding women.
- Clinical signs of thyrotoxicosis.
- Person placed under judicial protection,
- Patient suffering from serious psychiatric disease.
- Patients participating in another clinical trial.
- Contraindication to MRI
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: second propeller arm scanner
The experimental procedure is to conduct a second helical scanner strictly centered on the heart, 10 minutes after the first helix without inject contrast medium, to assess late enhancement to the inclusion visit.
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The experimental procedure is to conduct a second helical scanner strictly centered on the heart, 10 minutes after the first helix without inject contrast medium, to assess late enhancement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patient with a possible evaluation of myocardial viability using dual-energy cardiac CT
Time Frame: Day 4
|
To study the sensitivity of dual-energy cardiac CT for the evaluation of myocardial viability, in patients with late presentation myocardial infarction.
|
Day 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patient with a possible evaluation of myocardial viability using cardiac MRI
Time Frame: Day 4
|
To study the sensitivity of cardiac MRI for the evaluation of myocardial viability in patients with late presentation myocardial infarction.
|
Day 4
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Benjamin DUBOURG, Doctor, University Hospital, Rouen
- Study Director: Jean-Nicolas DACHER, Professor, University Hospital, Rouen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/205/HP
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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