Angina PectorisNCT01310725
Evaluation of Graft Material in Coronary Artery Bypass Grafting (CABG)
A study testing Coronary artery bypass grafting in people with Angina Pectoris, run by Region Örebro County at 1 site in Sweden.
Trial summary
The aim of the study is to evaluate the patency in different kinds of vessels used as graft material in coronary artery bypass grafting. The hypothesis is that vein grafts harvested with a pedicle of surrounding tissue have the same, or better, patency compared to radial grafts and that skeletonisation of the left… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Angina Pectoris
- What is being tested?
- Coronary artery bypass grafting
- Type of treatment
- Surgery or procedure
- How many people
- 108 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2004to Nov 2010
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Isolated coronary artery disease embracing all three main branches of the coronary artery tree.
Who cannot join
- Kidney insufficiency (Creatinine > 120 µmol/L)
- War-farin anticoagulation therapy
- Ejection fraction < 40%
- Repeat operation
- Other concurrent sur-gery
- Signs of reduced circulation in non-dominant hand
- Other severe illness, or if the patient declines to participate.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Cardiothoracic Surgery, Orebro University Hospital
Örebro, 701 85
About this study
Official title: Mid-term Patency of Radial Artery and No Touch Saphenous Vein as Grafts in CABG; A Randomised Controlled Trial.
The aim of the study is to evaluate the patency in different kinds of vessels used as graft material in coronary artery bypass grafting.
The hypothesis is that vein grafts harvested with a pedicle of surrounding tissue have the same, or better, patency compared to radial grafts and that skeletonisation of the left internal mammary artery does not effect the patency for this graft.
Read the detailed description
Patients undergoing coronary artery bypass grafting are included in the study.
Each patient receive a radial artery graft and a vein graft harvested with a pedicle of surrounding tissue to the right and left side of the heart respectively. The left internal mammary artery is used for the left anterior descending artery in a skeletonised or non-skeletonised fashion.
The evaluation is made with angiography up to 5 years after surgery.
- Conditions
- Angina Pectoris
- Being tested
- Coronary artery bypass grafting
- Keywords
- CABG, LIMA, saphenous vein, radial artery
- Medical subject headings
- Angina Pectoris
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
Bypass of stenoses in coronary arteries using different types os vessels as conduit.
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional grafts defined as opened or closed.
Measured: Up to 5 years after surgery.
Secondary outcomes (1)
Degree of stenosis in implanted grafts.
Measured: Up to 5 years after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startJan 2004
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Heart Lung Foundation, Regional Clinical Research
- Investigators
- Lars Norgren, MD, PhD, Prof., Study chair, OREBRO UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310725
- Sponsor's protocol ID
- mdr001
- Status last verified
- Sep 2010
- First submitted
- 7 Mar 2011
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid-term Patency of Radial Artery and No Touch Saphenous Vein as Grafts in CABG; A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT01310725
- Acronym / sponsor ID
- mdr001
- Conditions
- Angina Pectoris
- Keywords
- CABG, LIMA, saphenous vein, radial artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Swedish Heart Lung Foundation, Regional Clinical Research
- Study start
- Jan 2004
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 8 Mar 2011 (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 the study is to evaluate the patency in different kinds of vessels used as graft material in coronary artery bypass grafting.
The hypothesis is that vein grafts harvested with a pedicle of surrounding tissue have the same, or better, patency compared to radial grafts and that skeletonisation of the left internal mammary artery does not effect the patency for this graft.
Detailed description
Patients undergoing coronary artery bypass grafting are included in the study.
Each patient receive a radial artery graft and a vein graft harvested with a pedicle of surrounding tissue to the right and left side of the heart respectively. The left internal mammary artery is used for the left anterior descending artery in a skeletonised or non-skeletonised fashion.
The evaluation is made with angiography up to 5 years after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Isolated coronary artery disease embracing all three main branches of the coronary artery tree.
Key exclusion criteria (7 listed)
- Kidney insufficiency (Creatinine > 120 µmol/L)
- War-farin anticoagulation therapy
- Ejection fraction < 40%
- Repeat operation
- Other concurrent sur-gery
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 graftingBypass of stenoses in coronary arteries using different types os vessels as conduit. | Procedure or surgery | – |
Primary outcome
Functional grafts defined as opened or closed.
Time frame: Up to 5 years after surgery.
1 secondary outcome
Degree of stenosis in implanted grafts.
Time frame: Up to 5 years after surgery.
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 8 Mar 2011.
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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.
Lars Norgren, MD, PhD, Prof. study chair
OREBRO UNIVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary artery bypass grafting in people with Angina Pectoris, run by Region Örebro County at 1 site in Sweden.
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 7 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 8 Mar 2011. 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 Sweden. 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?
Functional grafts defined as opened or closed. (time frame: Up to 5 years after 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 8 Mar 2011.