Peripheral Arteriopathy Rate In Stroke (PARIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Erlangen-Nürnberg Medical School
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00794066
First received: November 18, 2008
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Peripheral Artery Disease
Procedure: measuring the ankle brachial index

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Peripheral Arterial Disease in Acute Ischemic and Hemorrhagic Stroke Patients

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Functional outcome (modified Rankin Scale) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 1500
Study Start Date: August 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
TIA
Procedure: measuring the ankle brachial index
Assessment of the ankle brachial index using the "boso-ABI-system 100" (www.boso.de).
2
Ischemic stroke
Procedure: measuring the ankle brachial index
Assessment of the ankle brachial index using the "boso-ABI-system 100" (www.boso.de).
3
Hemorrhagic stroke
Procedure: measuring the ankle brachial index
Assessment of the ankle brachial index using the "boso-ABI-system 100" (www.boso.de).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

consecutive patients with acute ischemic or hemorhagic stroke.

Criteria

Inclusion Criteria:

  • All consecutive adult patients with acute ischemic or hemorrhagic stroke.

Exclusion Criteria:

  • Congestive heart failure.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794066

Contacts
Contact: Hagen B. Huttner, MD +4991318544523 hagen.huttner@uk-erlangen.de
Contact: Martin Köhrmann, MD +4991318544544 martin.koehrmann@uk-erlangen.de

Locations
Germany
Department of Neurology, University of Erlangen, Germany Recruiting
Erlangen, Germany, 91054
Contact: Hagen B. Huttner, MD    +4991318544523    hagen.huttner@uk-erlangen.de   
Contact: Martin Köhrmann, MD    +4991318544544    martin.koehrmann@uk-erlangen.de   
Sub-Investigator: Hagen B. Huttner, MD         
Principal Investigator: Martin Köhrmann, MD         
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Study Director: Stefan Schwab, MD Head of the Department of Neurology, University of Erlangen, Germany
  More Information

No publications provided

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT00794066     History of Changes
Other Study ID Numbers: PARIS-Study2009
Study First Received: November 18, 2008
Last Updated: February 25, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University of Erlangen-Nürnberg Medical School:
PAD
Stroke
ICH
prevalence

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014