Endothelial Function of Saphenous Vein GraftsNCT01510821
Investigation of Endothelium in Saphenous Vein Grafts
A study testing Use of Maquet Vasoshield Pressure-limiting syringe on SVG and Use of non-regulated syringe on SVG in people with Endothelial Function of Saphenous Vein Grafts, run by Emory University at 2 sites in United States.
Trial summary
This is a single center prospective study of 30 patients undergoing elective heart bypass surgery (CABG) with at least two vein grafts from the leg (SVG). The purpose of this ex vivo study is to evaluate the function of vein grafts from small tissue samples treated with a pressure syringe and a non-pressure syringe. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Endothelial Function of Saphenous Vein Grafts
- What is being tested?
- Use of Maquet Vasoshield Pressure-limiting syringe on SVG and Use of non-regulated syringe on SVG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2011to Jun 2012
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing elective coronary artery bypass graft surgery requiring at least 2 saphenous vein grafts
Who cannot join
- patients undergoing any concomitant surgical procedures
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cardiothoracic Surgery Research Laboratory
Atlanta, Georgia, 30308
Emory University Hospital Midtown
Atlanta, Georgia, 30308
About this study
Official title: A Prospective Trial to Investigate Endothelial Dysfunction in Saphenous Vein Grafts Subjected to the Maquet Vasoshield Pressure Limiting Syringe Versus Non-Regulated Vessel Dilation in Patients Undergoing Coronary Artery Bypass Grafting
This is a single center prospective study of 30 patients undergoing elective heart bypass surgery (CABG) with at least two vein grafts from the leg (SVG). The purpose of this ex vivo study is to evaluate the function of vein grafts from small tissue samples treated with a pressure syringe and a non-pressure syringe. Syringes are routinely used to flush out the veins in preparation of bypass grafting. It is unknown if different levels of pressure in the syringe affect the vein or damage the vein. Small sections of tissue samples which are normally discarded will be obtained immediately after retrieval from the leg and before grafting to the heart. Tissue samples will be taken to the laboratory for study. There are no clinical endpoints in this study, however, clinical information will be obtained from the Society of Thoracic Surgeons database and will include demographics, risk factors, and perioperative outcomes.
- Being tested
- Use of Maquet Vasoshield Pressure-limiting syringe on SVG, Use of non-regulated syringe on SVG
- Keywords
- endoscopic vein harvest, saphenous vein graft, endothelial function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Maquet Vasoshield Pressure-limiting syringe on SVGOther
Also called Maquet device
Use of Maquet Vasoshield Pressure-limiting syringe on SVG
Use of non-regulated syringe on SVGOther
Also called standard syringe
Use of non-regulated syringe on SVG
| Study group | Role | What they receive |
|---|---|---|
| Maquet Vasoshield Arm | Experimental | Pressure limiting syringe Receives: Other: Use of Maquet Vasoshield Pressure-limiting syringe on SVG |
| Non-regulated Arm | Active comparator | standard non-regulated syringe Receives: Other: Use of non-regulated syringe on SVG |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVG vascular contractility
Measured: Day of surgery
Secondary outcomes (2)
Nitric oxide metabolite levels
Measured: Day of surgery
Major adverse cardiac events
Measured: 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial Function of Saphenous Vein GraftsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Maquet Cardiovascular
- Responsible party
- Principal investigator, Vinod Thourani, Emory University
- Investigators
- Vinod Thourani, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510821
- Sponsor's protocol ID
- IRB00049331
- Status last verified
- Sep 2013
- First submitted
- 2 Nov 2011
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial to Investigate Endothelial Dysfunction in Saphenous Vein Grafts Subjected to the Maquet Vasoshield Pressure Limiting Syringe Versus Non-Regulated Vessel Dilation in Patients Undergoing Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT01510821
- Acronym / sponsor ID
- IRB00049331
- Keywords
- endoscopic vein harvest, saphenous vein graft, endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Maquet Cardiovascular
- Study start
- Nov 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 18 Jan 2012 (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.
This is a single center prospective study of 30 patients undergoing elective heart bypass surgery (CABG) with at least two vein grafts from the leg (SVG). The purpose of this ex vivo study is to evaluate the function of vein grafts from small tissue samples treated with a pressure syringe and a non-pressure syringe. Syringes are routinely used to flush out the veins in preparation of bypass grafting. It is unknown if different levels of pressure in the syringe affect the vein or damage the vein. Small sections of tissue samples which are normally discarded will be obtained immediately after retrieval from the leg and before grafting to the heart. Tissue samples will be taken to the laboratory for study. There are no clinical endpoints in this study, however, clinical information will be obtained from the Society of Thoracic Surgeons database and will include demographics, risk factors, and perioperative outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maquet Vasoshield Arm | Experimental | Other: Use of Maquet Vasoshield Pressure-limiting syringe on SVGPressure limiting syringe |
| Non-regulated Arm | Active comparator | Other: Use of non-regulated syringe on SVGstandard non-regulated syringe |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing elective coronary artery bypass graft surgery requiring at least 2 saphenous vein grafts
Key exclusion criteria (1 listed)
- patients undergoing any concomitant surgical procedures
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 |
|---|---|---|
| Use of Maquet Vasoshield Pressure-limiting syringe on SVGAlso: Maquet deviceUse of Maquet Vasoshield Pressure-limiting syringe on SVG | Other | Maquet Vasoshield Arm |
| Use of non-regulated syringe on SVGAlso: standard syringeUse of non-regulated syringe on SVG | Other | Non-regulated Arm |
Primary outcome
SVG vascular contractility
Time frame: Day of surgery
2 secondary outcomes
Nitric oxide metabolite levels
Time frame: Day of surgery
Major adverse cardiac events
Time frame: 6 months and 1 year
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 1 Oct 2013.
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.
Vinod Thourani, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Maquet Vasoshield Pressure-limiting syringe on SVG and Use of non-regulated syringe on SVG in people with Endothelial Function of Saphenous Vein Grafts, run by Emory University at 2 sites in United States.
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 1 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 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?
SVG vascular contractility (time frame: Day of surgery). 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 1 Oct 2013.