Ischemic Heart DiseaseNCT00708838
Levels of Circulating T Cells Expressing VLA-1 Collagen Receptors
An observational study of Ischemic Heart Disease, run by Sheba Medical Center.
Trial summary
The examination of the percentage of peripheral T cells carrying VLA-1 in ischemic heart disease patients. The hypothesis is that the percentage levels of cells carrying this integrin rise according to the severity of the ischemic heart disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Heart Disease
- How many people
- 151 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Feb 2007
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of acute MI for group 1
- clinical diagnosis of ACSl for group 2
- clinical diagnosis of Chronic Heart Disease for groups 3 and 4
- Chest pain but normal heart scan for group 5
Who cannot join
- none
About this study
Official title: VLA-1 Receptors on Peripheral T Cells in Ischemic Heart Disease Patients
The examination of the percentage of peripheral T cells carrying VLA-1 in ischemic heart disease patients. The hypothesis is that the percentage levels of cells carrying this integrin rise according to the severity of the ischemic heart disease.
Read the detailed description
Atherosclerosis is considered an inflammatory disease in which lymphocytes have an important role. The study was disigned to find out the changes in T cell levels carrying VLA-1 involvement in this process.
- Conditions
- Ischemic Heart Disease
- Medical subject headings
- Myocardial Ischemia
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 |
|---|---|---|
| 1 | Not described | |
| 2 | Not described | |
| 3 | Not described | |
| 4 | Not described | |
| 5 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differance in percentage of T cells in the 5 different groups involved.
Measured: 2002-2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startJan 2002
- Primary completionJan 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708838
- Sponsor's protocol ID
- SHEBA-02-2707-AA-CTIL
- Status last verified
- Jul 2008
- First submitted
- 1 Jul 2008
- Last updated
- 2 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VLA-1 Receptors on Peripheral T Cells in Ischemic Heart Disease Patients
- ClinicalTrials.gov ID
- NCT00708838
- Acronym / sponsor ID
- SHEBA-02-2707-AA-CTIL
- Conditions
- Ischemic Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2002
- Primary completion
- Jan 2006 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 2 Jul 2008 (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 examination of the percentage of peripheral T cells carrying VLA-1 in ischemic heart disease patients. The hypothesis is that the percentage levels of cells carrying this integrin rise according to the severity of the ischemic heart disease.
Detailed description
Atherosclerosis is considered an inflammatory disease in which lymphocytes have an important role. The study was disigned to find out the changes in T cell levels carrying VLA-1 involvement in this process.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
| 2 | – | – |
| 3 | – | – |
| 4 | – | – |
| 5 | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical diagnosis of acute MI for group 1
- clinical diagnosis of ACSl for group 2
- clinical diagnosis of Chronic Heart Disease for groups 3 and 4
- Chest pain but normal heart scan for group 5
Key exclusion criteria (1 listed)
- none
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
The differance in percentage of T cells in the 5 different groups involved.
Time frame: 2002-2006
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease, run by Sheba Medical Center.
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 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: finished, as of the sponsor's last update on 2 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The differance in percentage of T cells in the 5 different groups involved. (time frame: 2002-2006). 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 2 Jul 2008.