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

March 26, 2021 updated by: George Ntaios, University of Thessaly

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Larissa, Greece, 41110
        • Medical School, University of Thessaly, Larissa University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Ischemic Stroke patients with atrial fibrillation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Rankin Scale at 3 months
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Thessaly

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2020

Primary Completion (Anticipated)

March 25, 2021

Study Completion (Anticipated)

April 5, 2021

Study Registration Dates

First Submitted

March 21, 2021

First Submitted That Met QC Criteria

March 26, 2021

First Posted (Actual)

March 29, 2021

Study Record Updates

Last Update Posted (Actual)

March 29, 2021

Last Update Submitted That Met QC Criteria

March 26, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFCAS 2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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