Evaluation of Infarct Size With 3D Rotational Angiography (EVATIAR)
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
3D RA
MRI
Sponsored by
About this trial
This is an interventional other trial for Myocardial Infarction focused on measuring Myocardial Infarction, MRI, rotational angiography
Eligibility Criteria
Inclusion Criteria:
Admitted for myocardial infarction and fulfilling the following criteria:
- Transitory or persistent ST elevation
- Coronary occlusion (TIMI 0) treated by angioplasty or thrombotic acute stenosis treated or not by angioplasty
- Planned coronarography
- With social security coverage
- Not under any legal protection;
- The consent form signed.
Exclusion Criteria:
- Patient unconscious or confused;
Presenting:
- cardiogenic shock;
- or signs of cardiac insufficiency;
- or sustained cardiac arrhythmia;
- or atrial fibrillation;
- or sustained extrasystole;
- or high degree block;
- Contraindication for MRI;
- Known history of hypersensitivity to MRI contrast agent;
- Risk of pregnancy or proven pregnancy based on interview data;
- Breast feeding;
- Patient subject to legal guardianship by a court;
- Incapacity to express consent;
- Patient not or badly understanding French.
Sites / Locations
- Hôpital Louis Pradel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient with Myocardial Infarction
Arm Description
Outcomes
Primary Outcome Measures
infarct size measured by RA
infarct size measured by MRI
Secondary Outcome Measures
Full Information
NCT ID
NCT02857985
First Posted
August 3, 2016
Last Updated
January 26, 2018
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT02857985
Brief Title
Evaluation of Infarct Size With 3D Rotational Angiography
Acronym
EVATIAR
Official Title
Evaluation of Infarct Size With 3D Rotational Angiography
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 9, 2013 (Actual)
Primary Completion Date
September 7, 2013 (Actual)
Study Completion Date
September 7, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The size of the infarct is particularly important prognostic marker. It is clearly established that the extent of the infarct is not only correlated to mortality, but also long-term adverse events. The evaluation of the infarct size at the acute phase of the disease is therefore an essential clinical tool to adapt the immediate treatment and follow-up of patients. It is therefore crucial to have techniques that are effective, precise, reproducible, and easily performed during the acute phase to quantify the size of the infarct following angioplasty. Myocardial scintigraphy and cardiac MRI have been the standard examinations for the evaluation of infarct size. However, these exams are difficult to perform during the acute phase of the infarct owing to difficulties in monitoring unstable patients and the limited availability of the apparatus. It is for this reason that the investigators would like to investigate the rotational angiography (RA), which is comparable to a scanner in its mode of action but does not require transfer of patients as performed using the same apparatus that used for diagnostic coronarography and therapeutic angioplasty. RA is a radiological technique that uses the system employed for coronagraph, and consists rotating the fixed C-Arm around the patient and acquisition of a series of images that are then reconstituted. The investigators propose to evaluate the size of the infarct using RA in comparison with cardiac MRI (standard examination) performed as soon as possible after RA and the investigators hope to demonstrated that RA allows the measurement of an infarct as precisely as cardiac MRI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Myocardial Infarction, MRI, rotational angiography
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient with Myocardial Infarction
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
3D RA
Intervention Description
3D RA is realised just after angioplasty.
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
MRI is realised between 24h and 96h post angioplasty.
Primary Outcome Measure Information:
Title
infarct size measured by RA
Time Frame
Day 1
Title
infarct size measured by MRI
Time Frame
Day 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Admitted for myocardial infarction and fulfilling the following criteria:
Transitory or persistent ST elevation
Coronary occlusion (TIMI 0) treated by angioplasty or thrombotic acute stenosis treated or not by angioplasty
Planned coronarography
With social security coverage
Not under any legal protection;
The consent form signed.
Exclusion Criteria:
Patient unconscious or confused;
Presenting:
cardiogenic shock;
or signs of cardiac insufficiency;
or sustained cardiac arrhythmia;
or atrial fibrillation;
or sustained extrasystole;
or high degree block;
Contraindication for MRI;
Known history of hypersensitivity to MRI contrast agent;
Risk of pregnancy or proven pregnancy based on interview data;
Breast feeding;
Patient subject to legal guardianship by a court;
Incapacity to express consent;
Patient not or badly understanding French.
Facility Information:
Facility Name
Hôpital Louis Pradel
City
Bron
ZIP/Postal Code
69500
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Infarct Size With 3D Rotational Angiography
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