Coronary Artery DiseaseNCT01089777
Monitoring and Characterization of Coronary Flow By Transthoracic Parametric Doppler (TPD) During Exercise Stress Test
An observational study of Coronary Artery Disease, run by Echosense Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- ultrasound Doppler monitoring
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2010to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Scheduled to exercise stress test
Who may be able to join
- Age 18 years or older
- Planned for ergometry test
- Signed informed consent
Who cannot join
- Excluded for stress test on a treadmill
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Coronary Artery Disease
- Being tested
- ultrasound Doppler monitoring
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound Doppler monitoringDevice
Ultrasound Doppler monitoring throughout the stress test
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitor coronary artery flow during exercise stress test.
Measured: 1-3 months following the stress test
Secondary outcomes (1)
Improve CAD predictive power of stress testing
Measured: 1-3 months following the stress test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Echosense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089777
- Sponsor's protocol ID
- DOP04
- Status last verified
- May 2011
- First submitted
- 16 Mar 2010
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring and Characterization of Coronary Flow By Transthoracic Parametric Doppler (TPD) During Exercise Stress Test
- ClinicalTrials.gov ID
- NCT01089777
- Acronym / sponsor ID
- DOP04
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Echosense Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 19 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Scheduled to exercise stress test
Key inclusion criteria (3 listed)
- Age 18 years or older
- Planned for ergometry test
- Signed informed consent
Key exclusion criteria (1 listed)
- Excluded for stress test on a treadmill
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound Doppler monitoringUltrasound Doppler monitoring throughout the stress test | Device | – |
Primary outcome
Monitor coronary artery flow during exercise stress test.
Time frame: 1-3 months following the stress test
1 secondary outcome
Improve CAD predictive power of stress testing
Time frame: 1-3 months following the stress test
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Echosense Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitor coronary artery flow during exercise stress test. (time frame: 1-3 months following the stress test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2014.