Stroke Telemedicine for Arizona Rural Residents Trial - Full Text View

Sponsor:	Mayo Clinic
Collaborator:	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

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Stroke Telemedicine for Arizona Rural Residents Trial

Resource links provided by NLM:

MedlinePlus related topics: Brain Diseases Vascular Diseases

U.S. FDA Resources

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

Locations

United States, Arizona
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054

Sponsors and Collaborators

Mayo Clinic

Arizona Department of Health Services

Investigators

Principal Investigator:	Bart M. Demerschalk, M.D.	Mayo Clinic
Principal Investigator:	Bentley J. Bobrow, M.D.	Mayo Clinic
Study Director:	Dwight D Channer, MS	Mayo Clinic

More Information

Additional Information:

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

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Capampangan DJ, Wellik KE, Bobrow BJ, Aguilar MI, Ingall TJ, Kiernan TE, Wingerchuk DM, Demaerschalk BM. Telemedicine versus telephone for remote emergency stroke consultations: a critically appraised topic. Neurologist. 2009 May;15(3):163-6.

Responsible Party:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00829361 History of Changes
Other Study ID Numbers:	08-005156
Study First Received:	January 26, 2009
Last Updated:	May 11, 2011
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

Additional relevant MeSH terms:

Brain Diseases
Cerebral Infarction
Stroke
Brain Ischemia
Cerebrovascular Disorders
Infarction
Ischemia

Vascular Diseases
Brain Infarction
Central Nervous System Diseases
Nervous System Diseases
Cardiovascular Diseases
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on May 24, 2012