Monitoring and Characterization of Coronary Flow By Transthoracic Parametric Doppler (TPD) During Exercise Stress Test

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01089777
Recruitment Status : Terminated
First Posted : March 19, 2010
Last Update Posted : August 5, 2014
Information provided by (Responsible Party):
Echosense Ltd.

Brief Summary:
The study is an open prospective study of coronary flow preferably of the left anterior descending artery (LAD), by a Transthoracic Parametric Doppler (TPD) system during conventional exercise stress test. The system is a noninvasive non-imaging device designed to monitor coronary flow velocity and display the data continuously during exercise stress tests. The system enables continuous monitoring of coronary flow during resting, stress loading and recovery phases. The study intent is to improve the stress test predictive value for CAD.

Condition or disease Intervention/treatment
Coronary Artery Disease Device: ultrasound Doppler monitoring

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : April 2010
Actual Primary Completion Date : January 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Device: ultrasound Doppler monitoring
    Ultrasound Doppler monitoring throughout the stress test

Primary Outcome Measures :
  1. Monitor coronary artery flow during exercise stress test. [ Time Frame: 1-3 months following the stress test ]

Secondary Outcome Measures :
  1. Improve CAD predictive power of stress testing [ Time Frame: 1-3 months following the stress test ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Scheduled to exercise stress test

Inclusion Criteria:

  • Age 18 years or older
  • Planned for ergometry test
  • Signed informed consent

Exclusion Criteria:

  • Excluded for stress test on a treadmill

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01089777

Cardiovascular department, Carmel medical center
Haifa, Israel, 34362
Sponsors and Collaborators
Echosense Ltd.

Responsible Party: Echosense Ltd. Identifier: NCT01089777     History of Changes
Other Study ID Numbers: DOP04
First Posted: March 19, 2010    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: May 2011

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases