Peripheral Arteriopathy Rate In Stroke (PARIS)
This study is currently recruiting participants.
Verified March 2013 by University of Erlangen-Nürnberg Medical School
Sponsor:
University of Erlangen-Nürnberg Medical School
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00794066
First received: November 18, 2008
Last updated: March 1, 2013
Last verified: March 2013
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | November 18, 2008 | ||||||||
| Last Updated Date | March 1, 2013 | ||||||||
| Start Date ICMJE | August 2008 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Functional outcome (modified Rankin Scale) [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00794066 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Prevalence of peripheral arterial disease [ Time Frame: during hospital stay ] [ Designated as safety issue: No ] Presence or not of PAD as assessed using ABI during hospital stay |
||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Peripheral Arteriopathy Rate In Stroke | ||||||||
| Official Title ICMJE | Prevalence of Peripheral Arterial Disease in Acute Ischemic and Hemorrhagic Stroke Patients | ||||||||
| Brief 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. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | consecutive patients with acute ischemic or hemorhagic stroke. |
||||||||
| Condition ICMJE | Peripheral Artery Disease | ||||||||
| Intervention ICMJE | Procedure: measuring the ankle brachial index
Assessment of the ankle brachial index using the "boso-ABI-system 100" (www.boso.de). |
||||||||
| Study Group/Cohort (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 1500 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00794066 | ||||||||
| Other Study ID Numbers ICMJE | PARIS-Study2009 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University of Erlangen-Nürnberg Medical School | ||||||||
| Study Sponsor ICMJE | University of Erlangen-Nürnberg Medical School | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | University of Erlangen-Nürnberg Medical School | ||||||||
| Verification Date | March 2013 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||