Back to resultsEvaluation of New Diagnostic Methods of Cardio-embolic Related (Atrial Fibrillation) Cerebral Infarction (IRMA2)
Primary Purpose
Stroke
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Abdominal scanner
Sponsored by
About this trial
This is an interventional diagnostic trial for Stroke focused on measuring Subdiaphragmatic infarction
Eligibility Criteria
Inclusion Criteria:
- Patient over 18
- Patient having a CHADS-VAsc Score ≥ 2;
- Patient hospitalized for a secondary established ischemic accident in an atrial fibrillation not anticoagulated (INR<2 and/or receiving antiplatelet (aspirin, clopidogrel)) for less than 14 days;
- Patient affiliated to a national insurance scheme or beneficiary
- Patient having given a written consent
Exclusion Criteria:
- Patient presenting cognitive disorders incompatible with the planned examinations (MRI / SCANNER).
- Pacemaker or implantable defibrillator, or other contraindication in the MRI (metallic eye brightness, intra cerebral clip).
- Contraindication in injected scanner.
- Current pregnancy
Sites / Locations
- Hôpital Foch
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stroke
Arm Description
Outcomes
Primary Outcome Measures
Number of patients with subdiaphragmatic infarctions detected by abdominal MRI
Secondary Outcome Measures
Number of patients with subdiaphragmatic infarctions detected by abdominal scanner
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02948140
Brief Title
Evaluation of New Diagnostic Methods of Cardio-embolic Related (Atrial Fibrillation) Cerebral Infarction
Acronym
IRMA2
Official Title
Evaluation of New Diagnostic Methods of Cardio-embolic Related (Atrial Fibrillation) Cerebral Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in recruiting patients
Study Start Date
June 13, 2016 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to estimate the contribution of abdominal imaging by magnetic resonance Imaging (MRI) and abdominal scanner in the detection of subdiaphragmatic infarction associated to the atrial fibrillation in the cerebral infarction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Subdiaphragmatic infarction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stroke
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
MRI
Intervention Type
Procedure
Intervention Name(s)
Abdominal scanner
Primary Outcome Measure Information:
Title
Number of patients with subdiaphragmatic infarctions detected by abdominal MRI
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Number of patients with subdiaphragmatic infarctions detected by abdominal scanner
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient over 18
Patient having a CHADS-VAsc Score ≥ 2;
Patient hospitalized for a secondary established ischemic accident in an atrial fibrillation not anticoagulated (INR<2 and/or receiving antiplatelet (aspirin, clopidogrel)) for less than 14 days;
Patient affiliated to a national insurance scheme or beneficiary
Patient having given a written consent
Exclusion Criteria:
Patient presenting cognitive disorders incompatible with the planned examinations (MRI / SCANNER).
Pacemaker or implantable defibrillator, or other contraindication in the MRI (metallic eye brightness, intra cerebral clip).
Contraindication in injected scanner.
Current pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand Lapergue, MD
Organizational Affiliation
Hôpital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20200339
Citation
Slaoui T, Klein IF, Guidoux C, Cabrejo L, Meseguer E, Abboud H, Lavalllee PC, Mazighi M, Labreuche J, Amarenco P. Prevalence of subdiaphragmatic visceral infarction in cardioembolic stroke. Neurology. 2010 Mar 30;74(13):1030-2. doi: 10.1212/WNL.0b013e3181d76aaa. Epub 2010 Mar 3.
Results Reference
background
PubMed Identifier
17379822
Citation
Abboud H, Labreuche J, Gongora-Riverra F, Jaramillo A, Duyckaerts C, Steg PG, Hauw JJ, Amarenco P. Prevalence and determinants of subdiaphragmatic visceral infarction in patients with fatal stroke. Stroke. 2007 May;38(5):1442-6. doi: 10.1161/STROKEAHA.106.476804. Epub 2007 Mar 22.
Results Reference
background
PubMed Identifier
23535494
Citation
Flint AC, Tayal AH. The search for paroxysmal atrial fibrillation in cryptogenic stroke: leave no stone unturned. Neurology. 2013 Apr 23;80(17):1542-3. doi: 10.1212/WNL.0b013e31828f1938. Epub 2013 Mar 27.
Results Reference
background
PubMed Identifier
15769776
Citation
White H, Boden-Albala B, Wang C, Elkind MS, Rundek T, Wright CB, Sacco RL. Ischemic stroke subtype incidence among whites, blacks, and Hispanics: the Northern Manhattan Study. Circulation. 2005 Mar 15;111(10):1327-31. doi: 10.1161/01.CIR.0000157736.19739.D0.
Results Reference
background
Learn more about this trial
Evaluation of New Diagnostic Methods of Cardio-embolic Related (Atrial Fibrillation) Cerebral Infarction
We'll reach out to this number within 24 hrs