Status:
COMPLETED
Remote Home Prothrombin Time (PT)/International Normalized Ratio (INR) Monitoring and Patient Management System
Lead Sponsor:
ZIN Technologies, Inc.
Collaborating Sponsors:
The Cleveland Clinic
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Long-term anticoagulation is indicated in patients for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or mechanical cardiac valve replacem...
Detailed Description
The creation of optimal devices for patient self-testing protocols for anticoagulation management is an area of active medical research. The current pilot study represents the initial step in the deve...
Eligibility Criteria
Inclusion
- Ages 18-80 years
- Requires long-term oral anticoagulation therapy for one of the following indications:
- Venous thromboembolism (deep vein thrombosis or pulmonary embolism)
- Arterial thromboembolic event(s)
- Atrial fibrillation
- Mechanical heart valve
- INR goal set at 2-3 by supervising physician
- Subject has been followed in the Vascular Medicine Coumadin program for at least 3 months
- No INR values \> 7, and no major thrombotic or bleeding complications within the preceding 3 months of follow-up in the Coumadin program.
- Subject has been compliant with INR monitoring during period of enrollment in the Vascular Medicine Coumadin program.
- Physically able and willing to perform finger stick INR measurements on self
- Able to use the hand-held monitoring device and have adequate vision to read information on the device screen
Exclusion
- Inability to speak and read English
- Anticipated interruption in anticoagulation within the next 6 months (e.g., for elective major surgery, pregnancy)
- Cognitive impairment which makes ability to perform necessary procedures related to the remote home monitoring device unlikely
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00978445
Start Date
September 1 2009
End Date
August 1 2010
Last Update
March 21 2013
Active Locations (1)
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1
Cleveland Clinic main campus
Cleveland, Ohio, United States, 44195