NCT04821700

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 21, 2021

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2021

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 21, 2021

Last Update Submit

March 26, 2021

Conditions

Keywords

Ischemic StrokeAtrial fibrillationcarotid stenosisatherosclerosis

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • modified Rankin Scale at 3 months

    3 months

Study Arms (2)

Patients with Carotid stenosis

Ischemic stroke patients with atrial fibrillation and carotid stenosis

Biological: Carotid Stenosis

Patients without Carotid stenosis

Ischemic stroke patients with atrial fibrillation without carotid stenosis

Interventions

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

Patients with Carotid stenosis

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ischemic Stroke patients with atrial fibrillation

You may qualify if:

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

You may not qualify if:

  • Intracerebral haemorrhage on admission
  • Haemorrhagic transformation on admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical School, University of Thessaly, Larissa University Hospital

Larissa, 41110, Greece

Location

MeSH Terms

Conditions

Ischemic StrokeAtrial FibrillationCarotid StenosisAtherosclerosis

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCarotid Artery DiseasesArterial Occlusive DiseasesArteriosclerosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 21, 2021

First Posted

March 29, 2021

Study Start

March 20, 2020

Primary Completion

March 25, 2021

Study Completion

April 5, 2021

Last Updated

March 29, 2021

Record last verified: 2021-03

Locations