Peripheral Arteriopathy Rate In Stroke | NCT00794066

Studies
Peripheral Arteriopathy Rate In Stroke

NCT00794066

Sponsor

University of Erlangen-Nürnberg Medical School

Status

Completed

Last Update Posted

Oct 25, 2017Actual

Enrollment

1,500Actual

Phase

Not provided

Conditions

Peripheral Artery Disease

Interventions

measuring the ankle brachial index

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Oct 23, 2017Actual

Completion Date

Oct 23, 2017Actual

First Submitted Date

Nov 18, 2008

First Submission Date that Met QC Criteria

Nov 18, 2008

First Posted Date

Nov 19, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2017

Last Update Posted Date

Oct 25, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
1	TIA	Procedure: measuring the ankle brachial index
2	Ischemic stroke	Procedure: measuring the ankle brachial index
3	Hemorrhagic stroke	Procedure: measuring the ankle brachial index

Interventions

Name	Type	Description	Arm Group Labels	Other Names
measuring the ankle brachial index	Procedure	Assessment of the ankle brachial index using the "boso-ABI-system 100" (www.boso.de).	1 2 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional outcome (modified Rankin Scale)		3 months

Secondary Outcomes

Measure	Description	Time Frame
Prevalence of peripheral arterial disease	Presence or not of PAD as assessed using ABI during hospital stay	during hospital stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All consecutive adult patients with acute ischemic or hemorrhagic stroke.

Exclusion Criteria:

Congestive heart failure.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

consecutive patients with acute ischemic or hemorhagic stroke.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stefan Schwab, MD	Head of the Department of Neurology, University of Erlangen, Germany	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology, University of Erlangen, Germany		Erlangen		91054	Germany

Condition Browse Module

MeSH Terms

ID	Term
D058729	Peripheral Arterial Disease
D020521	Stroke

Ancestor Terms

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided