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

Sponsor

University of Thessaly (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04821700

Collaborator

(none)

3,000

Enrollment

Location

12.5

Anticipated Duration (Months)

239.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke Atrial Fibrillation Carotid Stenosis	Biological: Carotid Stenosis

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 20, 2020

Anticipated Primary Completion Date :

Mar 25, 2021

Anticipated Study Completion Date :

Apr 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Patients with Carotid stenosis Ischemic stroke patients with atrial fibrillation and carotid stenosis	Biological: Carotid Stenosis To investigate if the concurrent presence of carotid stenosis has any effect on future outcomes of patients with ischemic stroke and atrial fibrillation
Patients without Carotid stenosis Ischemic stroke patients with atrial fibrillation without carotid stenosis

Arm

Intervention/Treatment

Patients with Carotid stenosis

Ischemic stroke patients with atrial fibrillation and carotid stenosis

Biological: Carotid Stenosis

To investigate if the concurrent presence of carotid stenosis has any effect on future outcomes of patients with ischemic stroke and atrial fibrillation

Patients without Carotid stenosis

Ischemic stroke patients with atrial fibrillation without carotid stenosis

Outcome Measures

Primary Outcome Measures

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

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