NCT04456309

Brief Summary

Acute infarction patterns have been described in cardioembolic stroke, mainly with atrial fibrillation (AF) or patent foramen ovale. We aimed to analyse acute infarction MRI characteristics in stroke patients with intracardiac thrombus (ICT) compared with stroke patients with AF.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

December 4, 2025

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

June 22, 2020

Last Update Submit

November 26, 2025

Conditions

StrokeIntracardiac Thrombus

Keywords

brain MRI

Outcome Measures

Primary Outcomes (4)

  • Brain MRI characteristics

    infarction location (anterior/middle/posterior cerebral artery territory; anterior/posterior/mixed anterior-posterior circulation; multiterritorial infarction; brainstem; cerebellum; small cortical cerebellar infarctions \[SCCI\] or non-SCCI; cortical/subcortical/corticosubcortical)

    Day of inclusion (Day 1)

  • Brain MRI characteristics

    lesion number

    Day of inclusion (Day 1)

  • Brain MRI characteristics

    subcortical lesion size (\>\<15 mm)

    Day of inclusion (Day 1)

  • Brain MRI characteristics

    total infarction volume.

    Day of inclusion (Day 1)

Study Arms (2)

Atrial fibrillation

stroke patients with atrial fibrillation

Other: No intervention,

Intracardiac thrombus

stroke patients with intracardiac thrombus

Other: No intervention,

Interventions

No intervention,OTHER

pure observational study

Atrial fibrillationIntracardiac thrombus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

2 groups of patients : 1 - Stroke patients with atrial fibrillation 2- Stroke patients with intracardiac thrombus

You may qualify if:

  • consecutive patients presenting with acute symptomatic cardioembolic infarction associated with ICT, recruited and registered in the stroke database between June 2018 and November 2019 of our centre (Nîmes University Hospital, France). These patients were compared with consecutive cardioembolic stroke patients with known or newly discovered AF (in the absence of ICT on echocardiography), recruited during the same time period.
  • Brain MRI (including diffusion-weighted imaging \[DWI\]) performed within one week of symptom onset; complete etiological work-up including intracranial (time-of-flight \[TOF\], gadolinium-enhanced magnetic resonance angiography \[MRA\], or computed tomographic angiography \[CTA\]) and extracranial (gadolinium-enhanced MRA, CTA, or duplex ultrasound) vessel imaging; transthoracic or transoesophageal echocardiography; and ≥24h ECG monitoring (acute stroke unit monitoring and/or Holter ECG monitoring).

You may not qualify if:

  • opt-out patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes

Nîmes, 30029, France

Location

Related Publications (2)

  • Renard D, Castelnovo G, Ion I, Guillamo JS, Thouvenot E. Single and simultaneous multiple intracerebral hemorrhages: a radiological review. Acta Neurol Belg. 2020 Aug;120(4):819-829. doi: 10.1007/s13760-020-01385-4. Epub 2020 May 24.

    PMID: 32449137RESULT

  • Trandafir C, Sandiramourty S, Laurent-Chabalier S, Ter Schiphorst A, Nguyen H, Wacongne A, Ricci JE, Pereira F, Thouvenot E, Renard D. Brain Infarction MRI Pattern in Stroke Patients with Intracardiac Thrombus. Cerebrovasc Dis. 2021;50(5):581-587. doi: 10.1159/000515707. Epub 2021 Jun 17.

    PMID: 34139688DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Dimitri RENARD

    Centre Hospitalier Universitaire de Nīmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2020

First Posted

July 2, 2020

Study Start

May 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

December 4, 2025

Record last verified: 2020-11

Locations

FR(1)