Ischemic Heart DiseaseNCT02339857
The Long-term Results of the No-touch Vein Graft to the Left Anterior Descending Artery.
An observational study of Ischemic Heart Disease and Atherosclerosis, run by Örebro County Council.
Trial summary
The purpose of this study was to investigate whether the no-touch saphenous vein grafts that were used in coronary artery bypass surgery between 2003-2008 had a patency rate comparable to the left internal thoracic artery when the vein grafts were anatomised to the left anterior descending artery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Heart Disease, Atherosclerosis
- What is being tested?
- No-touch harvesting technique
- Type of treatment
- Surgery or procedure
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Jun 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients that performed coronary artery bypass surgery between 2003-2008 and received a no-touch saphenous vein graft to the left anterior descending artery were included consecutively.
Who may be able to join
- Coronary artery bypass grafting performed at the Department of Cardiothoracic Surgery, Örebro Universtiy Hospital between 2003-2008.
- Saphenous vein graft harvesting using the no-touch technique.
- The saphenous vein anastomised to the left anterior descending artery.
- Informed consent
Who cannot join
- Allergy to contrast media.
- Impaired renal function.
- Inability to conduct the study according to protocol.
About this study
Official title: The Long-term Results of Coronary Artery Bypass Surgery When the No-touch Vein Graft is Anastomised to the Left Anterior Descending Artery.
The purpose of this study was to investigate whether the no-touch saphenous vein grafts that were used in coronary artery bypass surgery between 2003-2008 had a patency rate comparable to the left internal thoracic artery when the vein grafts were anatomised to the left anterior descending artery.
- Conditions
- Ischemic Heart Disease, Atherosclerosis
- Being tested
- No-touch harvesting technique
- Keywords
- coronary artery bypass grafting, saphenous vein, grafts
- Medical subject headings
- Myocardial Ischemia, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No-touch harvesting techniqueProcedure or surgery
The saphenous vein is harvested with a pedicle of surrounding tissue.
| Study group | Role | What they receive |
|---|---|---|
| No-touch vein grafts to LAD | Not described Receives: Procedure: No-touch harvesting technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total patency of the no-touch vein grafts.
Measured: Mean time 8 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startNov 2011
- Primary completionJun 2013
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro County Council
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ninos Samano M.D., Örebro University, Sweden
- Investigators
- Ninos Samano, MD, Principal investigator, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339857
- Sponsor's protocol ID
- 102881
- Status last verified
- Jan 2015
- First submitted
- 12 Jan 2015
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Results of Coronary Artery Bypass Surgery When the No-touch Vein Graft is Anastomised to the Left Anterior Descending Artery.
- ClinicalTrials.gov ID
- NCT02339857
- Acronym / sponsor ID
- 102881
- Conditions
- Ischemic Heart Disease, Atherosclerosis
- Keywords
- coronary artery bypass grafting, saphenous vein, grafts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Örebro County CouncilOther government
- Study start
- Nov 2011
- Primary completion
- Jun 2013 (actual)
- First posted
- 16 Jan 2015 (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 was to investigate whether the no-touch saphenous vein grafts that were used in coronary artery bypass surgery between 2003-2008 had a patency rate comparable to the left internal thoracic artery when the vein grafts were anatomised to the left anterior descending artery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No-touch vein grafts to LAD | – | Procedure: No-touch harvesting technique |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients that performed coronary artery bypass surgery between 2003-2008 and received a no-touch saphenous vein graft to the left anterior descending artery were included consecutively.
Key inclusion criteria (4 listed)
- Coronary artery bypass grafting performed at the Department of Cardiothoracic Surgery, Örebro Universtiy Hospital between 2003-2008.
- Saphenous vein graft harvesting using the no-touch technique.
- The saphenous vein anastomised to the left anterior descending artery.
- Informed consent
Key exclusion criteria (3 listed)
- Allergy to contrast media.
- Impaired renal function.
- Inability to conduct the study according to protocol.
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 |
|---|---|---|
| No-touch harvesting techniqueThe saphenous vein is harvested with a pedicle of surrounding tissue. | Procedure or surgery | No-touch vein grafts to LAD |
Primary outcome
Total patency of the no-touch vein grafts.
Time frame: Mean time 8 years.
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 16 Jan 2015.
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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.
Ninos Samano, MD principal investigator
Faculty of Medicine and Health, Örebro University, Örebro, Sweden
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease and Atherosclerosis, run by Örebro County Council.
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 3 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 16 Jan 2015. 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?
Total patency of the no-touch vein grafts. (time frame: Mean time 8 years.). 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 16 Jan 2015.