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Evaluation of Myocardial Viability : Dual Energy Cardiac CT vs. Cardiac MRI (InfarctusGSI)

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ClinicalTrials.gov Identifier: NCT02360150
Recruitment Status : Unknown
Verified August 2016 by University Hospital, Rouen.
Recruitment status was:  Recruiting
First Posted : February 10, 2015
Last Update Posted : August 17, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Radiation: second propeller arm scanner Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Myocardial Viability in Late Presentation Myocardial Infarction: Dual Energy Cardiac CT vs. Cardiac MRI.
Study Start Date : February 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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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.
 Radiation: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT02360150


Contacts
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Contact: Benjamin DUBOURG, Doctor 2 32 88 64 96 ext +33 Benjamin.Dubourg@chu-rouen.fr
Contact: Jérome CAUDRON, Doctor 2 32 88 64 96 ext +33 Jerome.Caudron@chu-rouen.fr

Locations
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France
University Hospital of Rouen Recruiting
Rouen, Normandie, France, 76031
Contact: Benjamin DUBOURG, Doctor    2 32 88 64 96 ext +33    Benjamin.Dubourg@chu-rouen.fr   
Sub-Investigator: Jérome CAUDRON, Doctor         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Benjamin DUBOURG, Doctor University Hospital, Rouen
Study Director: Jean-Nicolas DACHER, Professor University Hospital, Rouen
More Information
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02360150    
Other Study ID Numbers: 2013/205/HP
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016
Keywords provided by University Hospital, Rouen:
cardiac angiography
cardiac MRI
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases