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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04821700
Other study ID # AFCAS 2021
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 20, 2020
Est. completion date April 5, 2021

Study information

Verified date March 2021
Source University of Thessaly
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 3000
Est. completion date April 5, 2021
Est. primary completion date March 25, 2021
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Hospitalization due to ischemic stroke - Atrial fibrillation - ?ny type of carotid vascular imaging Exclusion Criteria: - Intracerebral haemorrhage on admission - Haemorrhagic transformation on admission

Study Design


Intervention

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

Locations

Country Name City State
Greece Medical School, University of Thessaly, Larissa University Hospital Larissa

Sponsors (1)

Lead Sponsor Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stroke recurrence From date of randomization until the date of stroke recurrence, assessed up to 60 months
Primary Myocardial infarction From date of randomization until the date of myocardial infarction, assessed up to 60 months
Primary Death during follow-up From date of randomization until the date of death from any cause, assessed up to 60 months
Secondary modified Rankin Scale at 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 3 months
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