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

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ClinicalTrials.gov Identifier: NCT01089777
Recruitment Status : Terminated
First Posted : March 19, 2010
Last Update Posted : August 5, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Phase
Coronary Artery Disease Device: ultrasound Doppler monitoring Early Phase 1

Study Design

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

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 ]

Eligibility Criteria

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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Excluded for stress test on a treadmill
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01089777


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

Responsible Party: Echosense Ltd.
ClinicalTrials.gov 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
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases