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
Recruitment status was Recruiting
Sponsor:
Echosense Ltd.
Information provided by:
Echosense Ltd.
ClinicalTrials.gov Identifier:
NCT01089777
First received: March 16, 2010
Last updated: May 19, 2011
Last verified: May 2011
| Tracking Information | |
|---|---|
| First Received Date ICMJE | March 16, 2010 |
| Last Updated Date | May 19, 2011 |
| Start Date ICMJE | April 2010 |
| Estimated Primary Completion Date | March 2012 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Monitor coronary artery flow during exercise stress test. [ Time Frame: 1-3 months following the stress test ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01089777 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
Improve CAD predictive power of stress testing [ Time Frame: 1-3 months following the stress test ] [ Designated as safety issue: No ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Monitoring and Characterization of Coronary Flow By Transthoracic Parametric Doppler (TPD) During Exercise Stress Test |
| Official Title ICMJE | Not Provided |
| 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. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Non-Probability Sample |
| Study Population | Scheduled to exercise stress test |
| Condition ICMJE | Coronary Artery Disease |
| Intervention ICMJE | Device: ultrasound Doppler monitoring
Ultrasound Doppler monitoring throughout the stress test |
| Study Group/Cohort (s) | Not Provided |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Recruiting |
| Estimated Enrollment ICMJE | 80 |
| Estimated Completion Date | September 2012 |
| Estimated Primary Completion Date | March 2012 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Not Provided |
| Location Countries ICMJE | Israel |
| Administrative Information | |
| NCT Number ICMJE | NCT01089777 |
| Other Study ID Numbers ICMJE | DOP04 |
| Has Data Monitoring Committee | No |
| Responsible Party | Rachel Schatzberger, Echosense |
| Study Sponsor ICMJE | Echosense Ltd. |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Echosense Ltd. |
| Verification Date | May 2011 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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