Home Monitoring for Atrial Fibrillation Using a Microlife Blood Pressure Monitor (TRIPPS)

January 6, 2010 updated by: Microlife

Home Monitoring for Atrial Fibrillation Using a Microlife Blood Pressure Monitor: Trial of Regular vs Irregualr Pulse for the Prevention of Stroke (TRIPPS 2.0)

This study assess the accuracy of a blood pressure monitor designed to detect atrial fibrillation. Subjects use the blood pressure monitor on a daily basis for 30 days and compare the readings to an ECG done at the same time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Flushing, New York, United States, 11355
        • Joseph Wiesel, MD medical office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients seen in a general medical practice.

Description

Inclusion Criteria: any of the following

  • age 65 or older
  • hypertension
  • diabetes mellitus
  • congestive heart failure
  • previous stroke

Exclusion Criteria:

  • permanent pacemaker
  • impalantable defibrillator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and specificity of the blood pressure monitor used for detecting atrial fibrillation compared to the electrocardiogram.
Time Frame: After final subject data is available.
After final subject data is available.

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess subjects understanding of the use of the device for atrial fibrillation.
Time Frame: After final subject data is available.
After final subject data is available.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Microlife

Investigators

  • Principal Investigator: Joseph Wiesel, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

March 10, 2009

First Submitted That Met QC Criteria

March 12, 2009

First Posted (ESTIMATE)

March 13, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 8, 2010

Last Update Submitted That Met QC Criteria

January 6, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tripps2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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