Atrial Fibrillation and Carotid Atherosclerosis in Ischemic Stroke Patients-(AFCAS)

• Conditions: Ischemic Stroke; Atrial Fibrillation; Carotid Stenosis
• Interventions: Biological: Carotid Stenosis

• Registration Number: NCT04821700
• Lead Sponsor: University of Thessaly

Brief Summary

The main aim of the study is to investigate the prevalence and characteristics of ischemic stroke patients with atrial fibrillation and concurrent carotid atherosclerosis. Additionally, this study will investigate the effect of concurrent carotid atherosclerosis on the outcomes of recurrent stroke, myocardial infarction and death during follow-up

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-20
• Status Verified: 2021-03
• Study First Submitted: 2021-03-21
• Primary Completion: 2021-03-25
• Study First Submitted QC: 2021-03-26
• Last Update Submitted: 2021-03-26
• Study First Posted: 2021-03-29
• Last Update Posted: 2021-03-29
• Study Completion: 2021-04-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Hospitalization due to ischemic stroke
• Atrial fibrillation
• Αny type of carotid vascular imaging

Exclusion Criteria

• Intracerebral haemorrhage on admission
• Haemorrhagic transformation on admission

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Carotid stenosis	Carotid Stenosis	Ischemic stroke patients with atrial fibrillation and carotid stenosis

Primary Outcome Measures

Name	Time	Method
Stroke recurrence	From date of randomization until the date of stroke recurrence, assessed up to 60 months
Myocardial infarction	From date of randomization until the date of myocardial infarction, assessed up to 60 months
Death during follow-up	From date of randomization until the date of death from any cause, assessed up to 60 months

Secondary Outcome Measures

Name	Time	Method
modified Rankin Scale at 3 months	3 months	mRS: modified Rankin Scale; 0=No symptoms at all; 1=No significant disability despite symptoms: able to carry out all usual duties and activities; 2=Slight disability: unable to carry out all previous activities, but able to look after own affairs without assistance; 3= Moderate disability: requiring some help, but able to walk without assistance; 4=Moderately severe disability: unable to walk without assistance and unable to attend to own bodily needs without assistance; 5=Severe disability: bedridden, incontinent and requiring constant nursing care and attention; 6=Dead

Trial Locations

Locations (1)

Medical School, University of Thessaly, Larissa University Hospital; 🇬🇷 Larissa, Greece