Myocardial IschemiaIMPROVE-CABGNCT01834846
Impact of Perivascular Tissue on Endothelial Function in Coronary Artery Bypass Grafting
A study testing no-touch and conventional in people with Myocardial Ischemia, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The success of coronary artery bypass grafting is reliant on the quality of the grafts used. A new technique for harvesting veins used as grafts has been introduced. The study hypothesis is that veins harvested with this technique have an improved endothelial function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- no-touch and conventional
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- May 2013to Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Isolated elective, primary CABG requiring cardiopulmonary bypass
- Left ventricular ejection fraction >35%
- at least one saphenous vein graft required as part of revascularization strategy
Who cannot join
- Acute or chronic inflammatory diseases
- Malignancies
- Pregnancy
- Previous cardiac surgery
- Serum creatinine >120 μmol/L
- Coagulopathy
Show all 11Show fewer
- Insulin dependent diabetes mellitus
- Smoking during last 6 months
- Leg not suitable for No-touch vein harvesting as judged by the operator.
- Need for nitrates on operation day
- not receiving statins
Trial locations and contacts
1 site in 1 country.
Norway1 site
Institute for Circulation and Imaging
Trondheim, Sør-Trøndelag, 7042
About this study
Official title: Impact of Perivascular Tissue on Endothelial Function and Vessel Structure in Vein Grafts Used for Coronary Artery Bypass Grafting: A Prospective, Randomized Controlled Trial.
The success of coronary artery bypass grafting is reliant on the quality of the grafts used. A new technique for harvesting veins used as grafts has been introduced. The study hypothesis is that veins harvested with this technique have an improved endothelial function.
- Conditions
- Myocardial Ischemia
- Being tested
- no-touch, conventional
- Keywords
- comparative study, Cardiac Surgical Procedures
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no-touchProcedure or surgery
The saphenous vein is exposed by a longitudinal incision, and all visible side branches ligated. The vein is then isolated together with a pedicle of surrounding tissue and manually distended and stored in a combination of blood and saline using a syringe, according to standard procedure at St. Olav's Hospital.
conventionalProcedure or surgery
The saphenous vein is exposed by a longitudinal leg incision, skeletonized from surrounding tissue, and side branches ligated. The vein is removed from the leg immediately after dissection, manually distended and stored in a combination of blood and saline using a syringe, according to standard procedure at St. Olav's Hospital.
| Study group | Role | What they receive |
|---|---|---|
| no-touch | Experimental | no-touch technique of harvesting the saphenous vein graft for coronary artery bypass grafting Receives: Procedure: no-touch |
| conventional | Active comparator | conventional technique of harvesting the saphenous vein graft for coronary artery bypass grafting Receives: Procedure: conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft function
Graft function as evaluated by coronary angiography in the first 60 out of 100 patients
Measured: 6 months
Graft function
Graft function as evaluated by coronary angiography in all 100 patients
Measured: 5 years
Secondary outcomes (5)
Morphological appearance of vein graft
As measured by angiography follow-up in the first 60 out of 100 patients
Measured: 6 months
Morphological appearance of vein graft
As measured by angiography follow-up in all 100 patients
Measured: 5 years
Postoperative leg wound complications
The following measures will be assessed in the first 60 out of 100 patients:
- Signs of infection
- Wound dehiscence
- Aesthetics
- Cutaneous sensory loss
- Wound discomfort
Measured: 6 weeks
Postoperative complications related to cardiac surgery
Major adverse cardiac and cerebral events in the first 60 out of 100 patients
- Postoperative complications
- Reoperation
- Sternal dehiscence
- Mediastinitis
Measured: Discharge, 6 weeks, 6 months
Postoperative complications related to cardiac surgery
Major adverse cardiac and cerebral events in all 100 patients
- Postoperative complications
- Reoperation
- Sternal dehiscence
- Mediastinitis
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2016
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Dag Ole Nordhaug, md phd, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834846
- Sponsor's protocol ID
- 090486
- Acronym
- IMPROVE-CABG
- Status last verified
- Dec 2020
- First submitted
- 15 Apr 2013
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pettersen O, Wiseth R, Hegbom K, Nordhaug DO. Pedicled Vein Grafts in Coronary Surgery Exhibit Reduced Intimal Hyperplasia at 6 Months. J Am Coll Cardiol. 2016 Jul 26;68(4):427-9. doi: 10.1016/j.jacc.2016.04.058. No abstract available.
PubMed 27443441Pettersen O, Haram PM, Winnerkvist A, Karevold A, Wahba A, Stenvik M, Wiseth R, Hegbom K, Nordhaug DO. Pedicled Vein Grafts in Coronary Surgery: Perioperative Data From a Randomized Trial. Ann Thorac Surg. 2017 Oct;104(4):1313-1317. doi: 10.1016/j.athoracsur.2017.03.076. Epub 2017 Jun 23.
PubMed 28648540Pettersen O, Pociask E, Malinowski KP, Slezak M, Hegbom K, Wiseth R, Nordhaug DO. Reproducibility of optical coherence tomography in vein grafts used for coronary revascularization. Cardiol J. 2020;27(5):518-523. doi: 10.5603/CJ.a2018.0139. Epub 2018 Nov 16.
PubMed 30444258
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Perivascular Tissue on Endothelial Function and Vessel Structure in Vein Grafts Used for Coronary Artery Bypass Grafting: A Prospective, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01834846
- Acronym / sponsor ID
- IMPROVE-CABG / 090486
- Conditions
- Myocardial Ischemia
- Keywords
- comparative study, Cardiac Surgical Procedures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- May 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 18 Apr 2013 (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 success of coronary artery bypass grafting is reliant on the quality of the grafts used. A new technique for harvesting veins used as grafts has been introduced. The study hypothesis is that veins harvested with this technique have an improved endothelial function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no-touch | Experimental | Procedure: no-touchno-touch technique of harvesting the saphenous vein graft for coronary artery bypass grafting |
| conventional | Active comparator | Procedure: conventionalconventional technique of harvesting the saphenous vein graft for coronary artery bypass grafting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Isolated elective, primary CABG requiring cardiopulmonary bypass
- Left ventricular ejection fraction >35%
- at least one saphenous vein graft required as part of revascularization strategy
Key exclusion criteria (11 listed)
- Acute or chronic inflammatory diseases
- Malignancies
- Pregnancy
- Previous cardiac surgery
- Serum creatinine >120 μmol/L
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-touchThe saphenous vein is exposed by a longitudinal incision, and all visible side branches ligated. The vein is then isolated together with a pedicle of surrounding tissue and manually distended and stored in a combination of blood and saline using a syringe, according to standard procedure at St. Olav's Hospital. | Procedure or surgery | no-touch |
| conventionalThe saphenous vein is exposed by a longitudinal leg incision, skeletonized from surrounding tissue, and side branches ligated. The vein is removed from the leg immediately after dissection, manually distended and stored in a combination of blood and saline using a syringe, according to standard procedure at St. Olav's Hospital. | Procedure or surgery | conventional |
Primary outcome
Graft function
Time frame: 6 months
Graft function as evaluated by coronary angiography in the first 60 out of 100 patients
Graft function
Time frame: 5 years
Graft function as evaluated by coronary angiography in all 100 patients
5 secondary outcomes
Morphological appearance of vein graft
Time frame: 6 months
Morphological appearance of vein graft
Time frame: 5 years
Postoperative leg wound complications
Time frame: 6 weeks
Postoperative complications related to cardiac surgery
Time frame: Discharge, 6 weeks, 6 months
Postoperative complications related to cardiac surgery
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Results publication: PubMed 27443441Pettersen O, Wiseth R, Hegbom K, Nordhaug DO. Pedicled Vein Grafts in Coronary Surgery Exhibit Reduced Intimal Hyperplasia at 6 Months. J Am Coll Cardiol. 2016 Jul 26;68(4):427-9. doi: 10.1016/j.jacc.2016.04.058. No abstract available.
- Results publication: PubMed 28648540Pettersen O, Haram PM, Winnerkvist A, Karevold A, Wahba A, Stenvik M, Wiseth R, Hegbom K, Nordhaug DO. Pedicled Vein Grafts in Coronary Surgery: Perioperative Data From a Randomized Trial. Ann Thorac Surg. 2017 Oct;104(4):1313-1317. doi: 10.1016/j.athoracsur.2017.03.076. Epub 2017 Jun 23.
- Derived from this study: PubMed 30444258Pettersen O, Pociask E, Malinowski KP, Slezak M, Hegbom K, Wiseth R, Nordhaug DO. Reproducibility of optical coherence tomography in vein grafts used for coronary revascularization. Cardiol J. 2020;27(5):518-523. doi: 10.5603/CJ.a2018.0139. Epub 2018 Nov 16.
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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.
Dag Ole Nordhaug, md phd principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing no-touch and conventional in people with Myocardial Ischemia, run by Norwegian University of Science and Technology at 1 site in Norway.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 5 Jan 2021. 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 Norway. 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?
Results are not available in the source record.
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?
Graft function (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01834846, which also lists 3 linked publications.
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 5 Jan 2021.