Coronary Artery DiseaseNCT00712192
Endoscopic Saphenous Vein Harvest for Coronary Artery Bypass Grafting
A study testing coronary artery bypass grafting in people with Coronary Artery Disease, run by Far Eastern Memorial Hospital.
Trial summary
Although the long saphenous vein remains the most commonly used conduit in coronary revascularization, traditional open vein harvest may lead to significantly impaired wound healing and post-operative pain. To this end, endoscopic saphenous vein harvesting techniques have been shown to reduce post-operative morbidity. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- coronary artery bypass grafting
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Dec 2007
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient with coronary artery disease underwent coronary artery bypass grafting in our hospital
Who cannot join
- no
About this study
Official title: The Impact on Endothelial Function and Integrity by Endoscopic Saphenous Vein Harvest for Coronary Artery Bypass Grafting
Although the long saphenous vein remains the most commonly used conduit in coronary revascularization, traditional open vein harvest may lead to significantly impaired wound healing and post-operative pain. To this end, endoscopic saphenous vein harvesting techniques have been shown to reduce post-operative morbidity. Studies have shown that endothelial integrity and luminal nitric oxide synthase (NOS) are better preserved with novel "no-touch" techniques; however, the effect and the associated mechanism of endoscopic vein harvest on endothelial integrity and function remain unknown. Therefore, in the present proposal, we will collect the saphenous vein segements immediately after harvesting, reperfusion, and grafting, and then use enzyme-linked immunosorbant assay (ELISA), immunohistochemical staining (IHC), and real-time polymerase chain reaction (RT-PCR) to detect the expression and distribution of endothelial NOS (eNOS), endothelin-1 (ET-1), vascular cell adhesion molecule-1 (VCAM-1), intracellular adhesion molecule-1 (ICAM-1), and platelet endothelial cell adhesion molecule-1(PECAM-1) at protein and RNA levels in the endothelium of saphenous veins. The major aim of this study is to elucidate the effect and mechanism of endoscopic saphenous vein harvesting on endothelial properties as compare to conventional open vein harvest technique.
- Conditions
- Coronary Artery Disease
- Being tested
- coronary artery bypass grafting
- Keywords
- coronary artery bypass grafting, endoscopic vein harvest, saphenous vein, endothelial cells, eNOS, ET-1
- 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.
coronary artery bypass graftingProcedure or surgery
patient with coroary artery diseases underwent coronary artery bypass grafting surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2007
- Study completionDec 2007
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712192
- Sponsor's protocol ID
- 95016
- Other IDs
- FEMH - 95 - C -002
- Status last verified
- Jul 2008
- First submitted
- 7 Jul 2008
- Last updated
- 9 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact on Endothelial Function and Integrity by Endoscopic Saphenous Vein Harvest for Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT00712192
- Acronym / sponsor ID
- 95016
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery bypass grafting, endoscopic vein harvest, saphenous vein, endothelial cells, eNOS, ET-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 9 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.
Although the long saphenous vein remains the most commonly used conduit in coronary revascularization, traditional open vein harvest may lead to significantly impaired wound healing and post-operative pain. To this end, endoscopic saphenous vein harvesting techniques have been shown to reduce post-operative morbidity. Studies have shown that endothelial integrity and luminal nitric oxide synthase (NOS) are better preserved with novel "no-touch" techniques; however, the effect and the associated mechanism of endoscopic vein harvest on endothelial integrity and function remain unknown. Therefore, in the present proposal, we will collect the saphenous vein segements immediately after harvesting, reperfusion, and grafting, and then use enzyme-linked immunosorbant assay (ELISA), immunohistochemical staining (IHC), and real-time polymerase chain reaction (RT-PCR) to detect the expression and distribution of endothelial NOS (eNOS), endothelin-1 (ET-1), vascular cell adhesion molecule-1 (VCAM-1), intracellular adhesion molecule-1 (ICAM-1), and platelet endothelial cell adhesion molecule-1(PECAM-1) at protein and RNA levels in the endothelium of saphenous veins. The major aim of this study is to elucidate the effect and mechanism of endoscopic saphenous vein harvesting on endothelial properties as compare to conventional open vein harvest technique.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patient with coronary artery disease underwent coronary artery bypass grafting in our hospital
Key exclusion criteria (1 listed)
- no
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 |
|---|---|---|
| coronary artery bypass graftingpatient with coroary artery diseases underwent coronary artery bypass grafting surgery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 9 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?
A study testing coronary artery bypass grafting in people with Coronary Artery Disease, run by Far Eastern Memorial Hospital.
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 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 9 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.
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 9 Jul 2008.