Ischemic StrokeNCT03948399
The Prevalence of a Low Ankle-Brachial Index in Acute Cerebral Ischemia.
An observational study of Ischemic Stroke, run by Jan Biziel University Hospital No 2 in Bydgoszcz at 1 site in Poland.
Trial summary
Aim of the study is assessment the prevalence of the low ankle-brachial index (ABI) defined less than or equal 0.9 in patients with acute cerebral ischemic event (stroke or transient ischemic attack) and determinate the correlation between ABI and internal carotid artery stenosis (ICAS) in the acute cerebral ischemic… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Duplex scanning of carotid arteries and ABI measurement
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2018to 31 Dec 2020
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending to hospital settings diagnosed with acute ischemic event (stroke or TIA) and control group individuals undergo computed tomography (CT) or magnetic resonance imaging (MRI) of the brain, lipid profile, had stroke risk factors assessed.
Who may be able to join
- Acute ischemic stroke or transient ischemic attack of anterior circulation
- Consent of patient
Who cannot join
- primary intracranial hemorrhage,
- venous sinus thrombosis,
- unconsciousness,
- intubation,
- inability to provide and write a consent application form.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University
Bydgoszcz, 85-168
Paweł Sokal, Ph.D., +48600954415, pawel.sokal@cm.umk.pl
Magdalena Konieczna- Brazis, M.D., +48 609 711 611, mpbrazis@wp.pl
About this study
Official title: The Prevalence of a Low Ankle-Brachial Index in Patients With Acute Cerebral Ischemic Event.
Aim of the study is assessment the prevalence of the low ankle-brachial index (ABI) defined less than or equal 0.9 in patients with acute cerebral ischemic event (stroke or transient ischemic attack) and determinate the correlation between ABI and internal carotid artery stenosis (ICAS) in the acute cerebral ischemic patients.
The low ABI is a strong marker of generalized atherosclerosis. LEAD is a strong independent predictor for stroke.
Read the detailed description
Aim of the study is assessment the prevalence of the low ankle-brachial index (ABI) defined less than or equal 0.9 in patients with acute cerebral ischemic event (stroke or transient ischemic attack) and determinate the correlation between ABI and internal carotid artery stenosis (ICAS) in the acute cerebral ischemic patients.
The ABI is a non-invasive tool useful for the diagnosis of LEAD. The low ABI is a strong marker of generalized atherosclerosis. LEAD is a strong independent predictor for stroke. Significant ICAS is prevalent among patients having LEAD. Acute ischemic stroke due to significant ICAS has poor prognosis.
Patients with LEAD may be a suitable subgroup for screening for ICAS using duplex scanning.
Estimating the relationship between cerebral ischemic event and the ABI value could help better guide preventive and risk reduction strategies.
- Conditions
- Ischemic Stroke
- Being tested
- Duplex scanning of carotid arteries, ABI measurement
- Keywords
- Ischemic Stroke, TIA, ABI, LEAD
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duplex scanning of carotid arteriesDevice
Measurement of carotid arteries
ABI measurementDevice
ankle brachial index (ABI) assessment
| Study group | Role | What they receive |
|---|---|---|
| STROKE GROUP | 150 patients admitted to Stroke Unit with a diagnosis of acute ischemic stroke (IS) or transient ischemic attack (TIA) Receives: Device: Duplex scanning of carotid arteries; Device: ABI measurement | |
| CONTROL GROUP | 50 individuals admitted to hospital without diagnosis of acute cerebrovascular disease; with diagnosis of dizziness, epilepsy, sclerosis multiplex. Receives: Device: Duplex scanning of carotid arteries; Device: ABI measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
ABI
Prevalence of a low ankle-brachial index (ABI) in patients with acute cerebral ischemic event
Measured: 7 days
Secondary outcomes (1)
ABI/ICAS
Correlation between ABI and internal carotid artery stenosis (ICAS) in the acute cerebral ischemic patients.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start1 Jan 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (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.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jan Biziel University Hospital No 2 in Bydgoszcz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pawel Sokal, Jan Biziel University Hospital No 2 in Bydgoszcz
- Investigators
- Paweł Sokal, Ph.D., Principal investigator, Jan Biziel University Hospital Collegium Medicum Nicolaus Copernicus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948399
- Sponsor's protocol ID
- JBUH-ABI-CIE-2018
- Status last verified
- May 2019
- First submitted
- 10 May 2019
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of a Low Ankle-Brachial Index in Patients With Acute Cerebral Ischemic Event.
- ClinicalTrials.gov ID
- NCT03948399
- Acronym / sponsor ID
- JBUH-ABI-CIE-2018
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic Stroke, TIA, ABI, LEAD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jan Biziel University Hospital No 2 in BydgoszczUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 13 May 2019 (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.
Aim of the study is assessment the prevalence of the low ankle-brachial index (ABI) defined less than or equal 0.9 in patients with acute cerebral ischemic event (stroke or transient ischemic attack) and determinate the correlation between ABI and internal carotid artery stenosis (ICAS) in the acute cerebral ischemic patients.
The low ABI is a strong marker of generalized atherosclerosis. LEAD is a strong independent predictor for stroke.
Detailed description
Aim of the study is assessment the prevalence of the low ankle-brachial index (ABI) defined less than or equal 0.9 in patients with acute cerebral ischemic event (stroke or transient ischemic attack) and determinate the correlation between ABI and internal carotid artery stenosis (ICAS) in the acute cerebral ischemic patients.
The ABI is a non-invasive tool useful for the diagnosis of LEAD. The low ABI is a strong marker of generalized atherosclerosis. LEAD is a strong independent predictor for stroke. Significant ICAS is prevalent among patients having LEAD. Acute ischemic stroke due to significant ICAS has poor prognosis.
Patients with LEAD may be a suitable subgroup for screening for ICAS using duplex scanning.
Estimating the relationship between cerebral ischemic event and the ABI value could help better guide preventive and risk reduction strategies.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STROKE GROUP | – | Device: Duplex scanning of carotid arteries, Device: ABI measurement150 patients admitted to Stroke Unit with a diagnosis of acute ischemic stroke (IS) or transient ischemic attack (TIA) |
| CONTROL GROUP | – | Device: Duplex scanning of carotid arteries, Device: ABI measurement50 individuals admitted to hospital without diagnosis of acute cerebrovascular disease; with diagnosis of dizziness, epilepsy, sclerosis multiplex. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending to hospital settings diagnosed with acute ischemic event (stroke or TIA) and control group individuals undergo computed tomography (CT) or magnetic resonance imaging (MRI) of the brain, lipid profile, had stroke risk factors assessed.
Key inclusion criteria (2 listed)
- Acute ischemic stroke or transient ischemic attack of anterior circulation
- Consent of patient
Key exclusion criteria (5 listed)
- primary intracranial hemorrhage,
- venous sinus thrombosis,
- unconsciousness,
- intubation,
- inability to provide and write a consent application form.
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 |
|---|---|---|
| Duplex scanning of carotid arteriesMeasurement of carotid arteries | Device | CONTROL GROUP, STROKE GROUP |
| ABI measurementankle brachial index (ABI) assessment | Device | CONTROL GROUP, STROKE GROUP |
Primary outcome
ABI
Time frame: 7 days
Prevalence of a low ankle-brachial index (ABI) in patients with acute cerebral ischemic event
1 secondary outcome
ABI/ICAS
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Individual participant dataSharing planned: No
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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.
Paweł Sokal, Ph.D. principal investigator
Jan Biziel University Hospital Collegium Medicum Nicolaus Copernicus University
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, run by Jan Biziel University Hospital No 2 in Bydgoszcz at 1 site in Poland.
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 2 inclusion and 5 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 13 May 2019. 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 Poland. 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?
Contact Paweł Sokal, Ph.D. (600954415 ext. 48, pawel.sokal@cm.umk.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ABI (time frame: 7 days). 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 13 May 2019.