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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01089777
First Posted: March 19, 2010
Last Update Posted: August 5, 2014
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.
Information provided by (Responsible Party):
Echosense Ltd.
  Purpose
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 Intervention Phase
Coronary Artery Disease Device: ultrasound Doppler monitoring Early Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Echosense Ltd.:

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

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

Enrollment: 60
Study Start Date: April 2010
Study Completion Date: February 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: ultrasound Doppler monitoring
    Ultrasound Doppler monitoring throughout the stress test
  Eligibility

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 Submitted: March 16, 2010
First Posted: March 19, 2010
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