Coronary Artery EctasiaNCT00548457
Endothelial Function in Patients With Ectatic Compared to Normal Coronary Arteries
An observational study of Coronary Artery Ectasia, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to show the frequency of endothelial dysfunction in patients suffering from ectatic coronary arteries as compared to those who have normal coronary arteries. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Ectasia
- How many people
- 76 participants
- Where
- 1 siteIsrael
- Study dates
- May 2006to 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients were recruited after passing cardiac catherization and diagnosed as having ectatic arteries.
Who may be able to join
- Ectatic coronary arteries defined by cardiac catheterization
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Heart Institute, Chaim Sheba Medical Center
Tel HaShomer, 52621
Micahel Shechter, MD, MA, 972-3-5302645, shechter@sheba.health.gov.il
Arik Asman, MD
About this study
The aim of this study is to show the frequency of endothelial dysfunction in patients suffering from ectatic coronary arteries as compared to those who have normal coronary arteries. Should this frequency be significant we would recommend initiating conventional treatment in those patients with ectatic coronary arteries as is the practice in patients with endothelial dysfunction without ectatic arteries
- Conditions
- Coronary Artery Ectasia
- Keywords
- the function of the endothelium of the arteries in patients suffering from ectatic coronary arteries
- Medical subject headings
- Coronary Aneurysm
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 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2007 (estimated)
- Study startMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery EctasiaStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Pierre Chouraqui, MD, Study chair, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548457
- Sponsor's protocol ID
- SHEBA-06-4130-PC-CTIL
- Status last verified
- Jan 2008
- First submitted
- 23 Oct 2007
- Last updated
- 29 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Function in Patients With Ectatic Compared to Normal Coronary Arteries
- ClinicalTrials.gov ID
- NCT00548457
- Acronym / sponsor ID
- SHEBA-06-4130-PC-CTIL
- Conditions
- Coronary Artery Ectasia
- Keywords
- the function of the endothelium of the arteries in patients suffering from ectatic coronary arteries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- May 2006
- First posted
- 24 Oct 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 aim of this study is to show the frequency of endothelial dysfunction in patients suffering from ectatic coronary arteries as compared to those who have normal coronary arteries. Should this frequency be significant we would recommend initiating conventional treatment in those patients with ectatic coronary arteries as is the practice in patients with endothelial dysfunction without ectatic arteries
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were recruited after passing cardiac catherization and diagnosed as having ectatic arteries.
Key inclusion criteria (1 listed)
- Ectatic coronary arteries defined by cardiac catheterization
Key exclusion criteria (0 listed)
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 29 Jan 2008.
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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.
Pierre Chouraqui, MD study chair
Sheba 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 Artery Ectasia, run by Sheba 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 1 inclusion and 0 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 29 Jan 2008. 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 ARIK ASMAN, MD (972-3-5302454, asman@sheba.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 29 Jan 2008.