NCT02948140

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

4.5 years

First QC Date

October 18, 2016

Last Update Submit

February 11, 2021

Conditions

Keywords

Subdiaphragmatic infarction

Outcome Measures

Primary Outcomes (1)

  • Number of patients with subdiaphragmatic infarctions detected by abdominal MRI

    14 days

Secondary Outcomes (1)

  • Number of patients with subdiaphragmatic infarctions detected by abdominal scanner

    14 days

Study Arms (1)

Stroke

EXPERIMENTAL
Procedure: MRIProcedure: Abdominal scanner

Interventions

MRIPROCEDURE
Stroke
Stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Foch

Suresnes, 92150, France

Location

Related Publications (4)

  • 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.

    PMID: 20200339BACKGROUND
  • 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.

    PMID: 17379822BACKGROUND
  • 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.

    PMID: 23535494BACKGROUND
  • 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.

    PMID: 15769776BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Bertrand Lapergue, MD

    Hôpital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2016

First Posted

October 28, 2016

Study Start

June 13, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

February 15, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations