Ischemic StrokeAFCASNCT04821700
Atrial Fibrillation and Carotid Atherosclerosis in Ischemic Stroke Patients-(AFCAS)
An observational study of Ischemic Stroke and Atrial Fibrillation, run by University of Thessaly at 1 site in Greece.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Stroke, Atrial Fibrillation, Carotid Stenosis
- What is being tested?
- Carotid Stenosis
- How many people
- 3,000 participants
- Where
- 1 siteGreece
- Study dates
- 20 Mar 2020to 5 Apr 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Ischemic Stroke patients with atrial fibrillation
Who may be able to join
- Hospitalization due to ischemic stroke
- Atrial fibrillation
- Αny type of carotid vascular imaging
Who cannot join
- Intracerebral haemorrhage on admission
- Haemorrhagic transformation on admission
Trial locations and contacts
1 site in 1 country.
Greece1 site
Medical School, University of Thessaly, Larissa University Hospital
Larissa, 41110
About this study
Official title: 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
- Conditions
- Ischemic Stroke, Atrial Fibrillation, Carotid Stenosis
- Being tested
- Carotid Stenosis
- Keywords
- Ischemic Stroke, Atrial fibrillation, carotid stenosis, atherosclerosis
- Medical subject headings
- Ischemic Stroke, Atrial Fibrillation, Carotid Stenosis, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid StenosisBiological
To investigate if the concurrent presence of carotid stenosis has any effect on future outcomes of patients with ischemic stroke and atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| Patients with Carotid stenosis | Ischemic stroke patients with atrial fibrillation and carotid stenosis Receives: Biological: Carotid Stenosis | |
| Patients without Carotid stenosis | Ischemic stroke patients with atrial fibrillation without carotid stenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke recurrence
Measured: From date of randomization until the date of stroke recurrence, assessed up to 60 months
Myocardial infarction
Measured: From date of randomization until the date of myocardial infarction, assessed up to 60 months
Death during follow-up
Measured: 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
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start20 Mar 2020
- Primary completion25 Mar 2021 (estimated)
- Study completion5 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Ntaios, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821700
- Sponsor's protocol ID
- AFCAS 2021
- Acronym
- AFCAS
- Status last verified
- Mar 2021
- First submitted
- 21 Mar 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Artery Atherosclerosis in Ischemic Stroke Patients With Atrial Fibrillation.(Atrial Fibrillation and Carotid Atherosclerosis in Ischemic Stroke Patients- AFCAS)
- ClinicalTrials.gov ID
- NCT04821700
- Acronym / sponsor ID
- AFCAS / AFCAS 2021
- Conditions
- Ischemic Stroke, Atrial Fibrillation, Carotid Stenosis
- Keywords
- Ischemic Stroke, Atrial fibrillation, carotid stenosis, atherosclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 25 Mar 2021 (estimated)
- Study completion
- 5 Apr 2021 (estimated)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Carotid stenosis | – | Biological: Carotid StenosisIschemic stroke patients with atrial fibrillation and carotid stenosis |
| Patients without Carotid stenosis | – | –Ischemic stroke patients with atrial fibrillation without carotid stenosis |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Ischemic Stroke patients with atrial fibrillation
Key inclusion criteria (3 listed)
- Hospitalization due to ischemic stroke
- Atrial fibrillation
- Αny type of carotid vascular imaging
Key exclusion criteria (2 listed)
- Intracerebral haemorrhage on admission
- Haemorrhagic transformation on admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid StenosisTo investigate if the concurrent presence of carotid stenosis has any effect on future outcomes of patients with ischemic stroke and atrial fibrillation | Biological | Patients with Carotid stenosis |
Primary outcome
Stroke recurrence
Time frame: 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
Death during follow-up
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
1 secondary outcome
modified Rankin Scale at 3 months
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Atrial Fibrillation, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke recurrence (time frame: From date of randomization until the date of stroke recurrence, assessed up to 60 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.