Peripheral Artery DiseasePARISNCT00794066
Peripheral Arteriopathy Rate In Stroke
An observational study of Peripheral Artery Disease, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
Purpose: To assess the prevalence of peripheral arterial disease (PAD) in acute stroke patients. Interventions: Assessment of the ankle brachial index using the "boso-ABI-system 100" (www.boso.de). Design: Prospective, open, cohort study. Study size planned: 1500. Follow-up duration: 3 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- measuring the ankle brachial index
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2008to 23 Oct 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive patients with acute ischemic or hemorhagic stroke.
Who may be able to join
- All consecutive adult patients with acute ischemic or hemorrhagic stroke.
Who cannot join
- Congestive heart failure.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology, University of Erlangen, Germany
Erlangen, 91054
About this study
Official title: Prevalence of Peripheral Arterial Disease in Acute Ischemic and Hemorrhagic Stroke Patients
Purpose:
To assess the prevalence of peripheral arterial disease (PAD) in acute stroke patients.
Interventions:
Assessment of the ankle brachial index using the "boso-ABI-system 100" (www.boso.de).
Design:
Prospective, open, cohort study.
Study size planned:
1500.
Follow-up duration:
3 months.
- Conditions
- Peripheral Artery Disease
- Being tested
- measuring the ankle brachial index
- Keywords
- PAD, Stroke, ICH, prevalence
- Medical subject headings
- Peripheral Arterial Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measuring the ankle brachial indexProcedure or surgery
Assessment of the ankle brachial index using the "boso-ABI-system 100" (www.boso.de).
| Study group | Role | What they receive |
|---|---|---|
| 1 | TIA Receives: Procedure: measuring the ankle brachial index | |
| 2 | Ischemic stroke Receives: Procedure: measuring the ankle brachial index | |
| 3 | Hemorrhagic stroke Receives: Procedure: measuring the ankle brachial index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome (modified Rankin Scale)
Measured: 3 months
Secondary outcomes (1)
Prevalence of peripheral arterial disease
Presence or not of PAD as assessed using ABI during hospital stay
Measured: during hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startAug 2008
- Primary completion23 Oct 2017
- Study completion23 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Schwab, MD, Study director, Head of the Department of Neurology, University of Erlangen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794066
- Sponsor's protocol ID
- PARIS-Study2009
- Acronym
- PARIS
- Status last verified
- Oct 2017
- First submitted
- 18 Nov 2008
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Peripheral Arterial Disease in Acute Ischemic and Hemorrhagic Stroke Patients
- ClinicalTrials.gov ID
- NCT00794066
- Acronym / sponsor ID
- PARIS / PARIS-Study2009
- Conditions
- Peripheral Artery Disease
- Keywords
- PAD, Stroke, ICH, prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- 23 Oct 2017 (actual)
- Study completion
- 23 Oct 2017 (actual)
- First posted
- 19 Nov 2008 (estimated)
- 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.
Purpose:
To assess the prevalence of peripheral arterial disease (PAD) in acute stroke patients.
Interventions:
Assessment of the ankle brachial index using the "boso-ABI-system 100" (www.boso.de).
Design:
Prospective, open, cohort study.
Study size planned:
1500.
Follow-up duration:
3 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: measuring the ankle brachial indexTIA |
| 2 | – | Procedure: measuring the ankle brachial indexIschemic stroke |
| 3 | – | Procedure: measuring the ankle brachial indexHemorrhagic stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients with acute ischemic or hemorhagic stroke.
Key inclusion criteria (1 listed)
- All consecutive adult patients with acute ischemic or hemorrhagic stroke.
Key exclusion criteria (1 listed)
- Congestive heart failure.
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 |
|---|---|---|
| measuring the ankle brachial indexAssessment of the ankle brachial index using the "boso-ABI-system 100" (www.boso.de). | Procedure or surgery | 1, 2, 3 |
Primary outcome
Functional outcome (modified Rankin Scale)
Time frame: 3 months
1 secondary outcome
Prevalence of peripheral arterial disease
Time frame: during hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
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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.
Stefan Schwab, MD study director
Head of the Department of Neurology, University of Erlangen, Germany
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 Peripheral Artery Disease, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Oct 2017. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional outcome (modified Rankin Scale) (time frame: 3 months). 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 25 Oct 2017.