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

Primary Purpose

Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
second propeller arm scanner
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Infarction focused on measuring cardiac angiography, cardiac MRI

Eligibility Criteria

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

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

Sites / Locations

  • University Hospital of RouenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

second propeller arm scanner

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of patient with a possible evaluation of myocardial viability using dual-energy cardiac CT
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

Number of patient with a possible evaluation of myocardial viability using cardiac MRI
To study the sensitivity of cardiac MRI for the evaluation of myocardial viability in patients with late presentation myocardial infarction.

Full Information

First Posted
December 15, 2014
Last Updated
August 16, 2016
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT02360150
Brief Title
Evaluation of Myocardial Viability : Dual Energy Cardiac CT vs. Cardiac MRI
Acronym
InfarctusGSI
Official Title
Evaluation of Myocardial Viability in Late Presentation Myocardial Infarction: Dual Energy Cardiac CT vs. Cardiac MRI.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
cardiac angiography, cardiac MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
second propeller arm scanner
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
second propeller arm scanner
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patient with a possible evaluation of myocardial viability using dual-energy cardiac CT
Description
To study the sensitivity of dual-energy cardiac CT for the evaluation of myocardial viability, in patients with late presentation myocardial infarction.
Time Frame
Day 4
Secondary Outcome Measure Information:
Title
Number of patient with a possible evaluation of myocardial viability using cardiac MRI
Description
To study the sensitivity of cardiac MRI for the evaluation of myocardial viability in patients with late presentation myocardial infarction.
Time Frame
Day 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin DUBOURG, Doctor
Phone
2 32 88 64 96
Ext
+33
Email
Benjamin.Dubourg@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jérome CAUDRON, Doctor
Phone
2 32 88 64 96
Ext
+33
Email
Jerome.Caudron@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin DUBOURG, Doctor
Organizational Affiliation
University Hospital, Rouen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Nicolas DACHER, Professor
Organizational Affiliation
University Hospital, Rouen
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Rouen
City
Rouen
State/Province
Normandie
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin DUBOURG, Doctor
Phone
2 32 88 64 96
Ext
+33
Email
Benjamin.Dubourg@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Jérome CAUDRON, Doctor

12. IPD Sharing Statement

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

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