Coronary StenosisNCT00521326
Diagnosis and Characterization of Coronary Artery Stenosis by Doppler Ultrasound
An observational study of Coronary Stenosis, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to evaluate the feasibility of acquisition of coronary blood flow velocity signals over the whole length of the LAD with transthoracic pulsed Doppler, and to evaluate the diagnostic power of the transthoracic Doppler analysis package for detecting and estimating the degree of coronary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Stenosis
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Aug 2007to not given
- 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
- Adult, Older adult
Who may be able to join
- Patients who are clinically suspected of having significant coronary artery stenosis.
- Patients with CAD.
- Patients who are scheduled to undergo coronary angiography.
- Signed informed consent.
Who cannot join
- Patients with arrhythmia / irregular pulse
- Patients with unstable conditions: unstable angina, uncontrolled CHF
- Patients with COPD
- Any physical or medical disability that prevent lying in supine position
- Patients with chest wall deformity
Trial locations and contacts
1 site in 1 country.
Israel1 site
Coronary Care Unit, Heart Institute, Hille Yaffe Medical Center
Hadera, 38100
Simcha R Meisel, MD, MSc, 972-4-630-4656, meisel@hy.health.gov.il
Simcha R Meisel, MD, MSc
About this study
Official title: Diagnosis and Characterization of Coronary Artery Stenosis by Transthoracic Doppler Ultrasound
The purpose of this study is to evaluate the feasibility of acquisition of coronary blood flow velocity signals over the whole length of the LAD with transthoracic pulsed Doppler, and to evaluate the diagnostic power of the transthoracic Doppler analysis package for detecting and estimating the degree of coronary artery stenosis. Finally we hope to optimize the currently available analysis package on the basis of the comparison of the Doppler with the angiographic stenosis results and evaluation.
- Conditions
- Coronary Stenosis
- Keywords
- doppler, coronary stenosis, non-invasive testing, A prospective study of a new diagnostic method., Study consists of a transthoracic doppler of LAD., Doppler to be performed prior to coronary angiography., F/U doppler examination for those who undergo PCI., Doppler results will be compared with coronary angiography.
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Patients with an acute coronary syndrome that are candidates for coronary angiography. Doppler results will be compared to angiographic findings. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study startAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies 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
- Defined population
- Time perspective
- Other
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Investigators
- Simcha R Meisel, MD, MSc, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521326
- Sponsor's protocol ID
- DOP01
- Status last verified
- Mar 2007
- First submitted
- 24 Aug 2007
- Last updated
- 27 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Characterization of Coronary Artery Stenosis by Transthoracic Doppler Ultrasound
- ClinicalTrials.gov ID
- NCT00521326
- Acronym / sponsor ID
- DOP01
- Conditions
- Coronary Stenosis
- Keywords
- doppler, coronary stenosis, non-invasive testing, A prospective study of a new diagnostic method., Study consists of a transthoracic doppler of LAD., Doppler to be performed prior to coronary angiography., F/U doppler examination for those who undergo PCI., Doppler results will be compared with coronary angiography.
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Aug 2007
- First posted
- 27 Aug 2007 (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 purpose of this study is to evaluate the feasibility of acquisition of coronary blood flow velocity signals over the whole length of the LAD with transthoracic pulsed Doppler, and to evaluate the diagnostic power of the transthoracic Doppler analysis package for detecting and estimating the degree of coronary artery stenosis. Finally we hope to optimize the currently available analysis package on the basis of the comparison of the Doppler with the angiographic stenosis results and evaluation.
Study design
- Observational model
- Defined population
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | –Patients with an acute coronary syndrome that are candidates for coronary angiography. Doppler results will be compared to angiographic findings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are clinically suspected of having significant coronary artery stenosis.
- Patients with CAD.
- Patients who are scheduled to undergo coronary angiography.
- Signed informed consent.
Key exclusion criteria (5 listed)
- Patients with arrhythmia / irregular pulse
- Patients with unstable conditions: unstable angina, uncontrolled CHF
- Patients with COPD
- Any physical or medical disability that prevent lying in supine position
- Patients with chest wall deformity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2007.
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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.
Simcha R Meisel, MD, MSc principal investigator
Hillel Yaffe Medical Center
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 Stenosis, run by Hillel Yaffe Medical Center 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Aug 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simcha R Meisel, MD, MSc (972-4-630-4656, meisel@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 27 Aug 2007.