Brain MRI in Stroke Patients With Intracardiac Thrombus

Stroke Clinical Trial

— BRAIN IRM  

Official title:

Brain MRI Characteristics in Stroke Patients With Intracardiac Thrombus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04456309
• Other study ID #: LOCAL/2020/DR-02
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: November 15, 2020

Study information

• Verified date: November 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: November 15, 2020
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• opt-out patient

Related Conditions & MeSH terms

• Intracardiac Thrombus
• Stroke
• Thrombosis

Intervention

Other:
• No intervention,
pure observational study

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Brain MRI characteristics	lesion number	Day of inclusion (Day 1)
Primary	Brain MRI characteristics	subcortical lesion size (><15 mm)	Day of inclusion (Day 1)
Primary	Brain MRI characteristics	total infarction volume.	Day of inclusion (Day 1)