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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Echosense Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Echosense Ltd.
ClinicalTrials.gov Identifier:
NCT01089777
First received: March 16, 2010
Last updated: May 19, 2011
Last verified: May 2011
History of Changes
  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
 Phase 0

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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improve CAD predictive power of stress testing [ Time Frame: 1-3 months following the stress test ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: April 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: ultrasound Doppler monitoring
    Ultrasound Doppler monitoring throughout the stress test
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089777

Locations
Israel
Cardiovascular department, Carmel medical center Recruiting
Haifa, Israel, 34362
Contact: Basil Lewis, Prof     972-4-8250288     lewis@tx.technion.ac.il    
Principal Investigator: Basil Lewis, Prof            
Sponsors and Collaborators
Echosense Ltd.
  More Information

No publications provided

Responsible Party: Rachel Schatzberger, Echosense
ClinicalTrials.gov Identifier: NCT01089777     History of Changes
Other Study ID Numbers: DOP04
Study First Received: March 16, 2010
Last Updated: May 19, 2011
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on June 18, 2013