Stroke Telemedicine for Arizona Rural Residents Trial - Full Text View

Stroke Telemedicine for Arizona Rural Residents Trial (STARR)

This study is currently recruiting participants.

Verified by Mayo Clinic, March 2009

First Received: January 26, 2009 Last Updated: March 17, 2009 History of Changes

Sponsors and Collaborators:	Mayo Clinic Arizona Department of Health Services
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00829361

Purpose

The STARR network registry consists of a 4 spoke 1 hub system. Which will consist of prospective collection, recording, and regular analysis of telestroke patient consultation and care data for the purpose of quality measure assessment and improvement and benchmarking against other national and international telestroke programs.

Condition	Intervention
Stroke Cerebral Infarction Vascular Diseases Brain Ischemia Brain Infarction Brain Diseases Cerebrovascular Disorders	Other: Telemedicine

MedlinePlus related topics: Brain Diseases Vascular Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Stroke Telemedicine for Arizona Rural Residents Trial

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

To assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the functional outcomes of acute stroke subjects by Barthel index and Modified Rankin Scale [ Time Frame: 90 days ] [ Designated as safety issue: No ]
To assess the rate of intracranial hemorrhage post thrombolysis [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	500
Study Start Date:	October 2008
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Two way site independent audio/video telemedicine system with DICOM.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients presenting to Rural Emergency Department within 12 hours of acute stroke symptom onset.
Written informed consent.

Exclusion Criteria:

Unlikely to complete study through 90-day follow-up.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829361

Contacts

Contact: Bart M. Demaerschalk, M.D.	480-342-3370	demaerschalk.bart@mayo.edu
Contact: Terri E.J. Kiernan, MSN, NP-BC	480-342-3076	kiernan.terri@mayo.edu

Locations

United States, Arizona
Mayo Clinic Hospital	Recruiting
Phoenix, Arizona, United States, 85054
Contact: Terri E.J. Kiernan, MSN 480-342-3076 kiernan.terri@mayo.edu

Sponsors and Collaborators

Mayo Clinic

Arizona Department of Health Services

Investigators

Principal Investigator:	Bart M. Demerschalk, M.D.	Mayo Clinic Arizona
Principal Investigator:	Bentley J. Bobrow, M.D.	Mayo Clinic Arizona
Study Director:	Terri E.J. Kiernan, MSN	Mayo Clinic Arizona

More Information

Additional Information:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mayo Clinic ( Mayo Clinic )
Study ID Numbers:	08-005156
Study First Received:	January 26, 2009
Last Updated:	March 17, 2009
ClinicalTrials.gov Identifier:	NCT00829361 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

Telemedicine
Acute stroke
Rural
thrombosis
consultation
Stroke

Cerebral Infarction
Vascular diseases
brain ischemia
brain infarction
brain diseases
cerebrovascular disorders

Study placed in the following topic categories:

Necrosis
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Brain Ischemia

Ischemia
Brain Infarction
Infarction
Brain Diseases
Cerebrovascular Disorders
Thrombosis

Additional relevant MeSH terms:

Cerebral Infarction
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases

Cerebrovascular Disorders
Necrosis
Pathologic Processes
Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Infarction

ClinicalTrials.gov processed this record on May 07, 2009