Complications Due to Coronary Artery Bypass GraftMAQEHNCT02471456
MACCE After Endoscopic Vein Harvest for CABG
An observational study of Complications Due to Coronary Artery Bypass Graft, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Most patients undergoing coronary artery bypass grafting (CABG) will require long saphenous vein (LSV) harvesting from the leg. This has been reported to be associated with a significant morbidity (leg swelling, pain, infection, bruising, wound discharge) in up to 50% of patients. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Complications Due to Coronary Artery Bypass Graft
- What is being tested?
- Quality of Life Questionnaire and MACCE review
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to 16 Oct 2015
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Fifty patients who underwent EVH (Study group) were part of our service evaluation when EVH was introduced to our practice. These patients were matched with patients undergoing CABG during the same period but where the LSV was harvested by OVH (50 patients, control group). This service evaluation showed a significant cost benefit when EVH was used in terms of reduction in the inhopsital stay, leg wound pain, leg wound infection and need to attend wound clinic. The current study is an extension of the service evaluation to assess how these patients are doing at least a year after their surgery in terms of MACCE, QOL,return to normal activities and survival
Who may be able to join
- Patient underwent CABG (isolated or combined) during period Jan 2012 to Dec 2013
- LSV harvested by EVH (Study group)
- LSV Harvested by OVH matched with EVH group (Control group)
Who cannot join
- 1. Patient deceased at time of study start
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Wolverhampton NHS Trust
Wolverhampton, WV10 0QP
About this study
Official title: Major Adverse Cardiac and Cerebrovascular Event (MACCE) & Patients' Quality of Life (QOL) After Endoscopic Vein Harvesting as Compared to Open Vein Harvest for Coronary Artery Bypass Grafting
Most patients undergoing coronary artery bypass grafting (CABG) will require long saphenous vein (LSV) harvesting from the leg. This has been reported to be associated with a significant morbidity (leg swelling, pain, infection, bruising, wound discharge) in up to 50% of patients. Endoscopic vein harvesting (EVH) which has been reported to be associated with a reduction in these complications was implemented within the investigators' service in 2012. Although some initial reports of concerns regarding graft patency when the LSV is harvested by EVH, NICE and European Cardiology Society (ESC/EACTS) guidelines 2014 supported the use of the EVH technology. Last year a service evaluation in the investigators' department showed significant cost benefit of EVH as compared to open vein harvest (OVH) in a matched group (50 EVH and 50 OVH patients). The purpose of this study is to evaluate this group further to assess the incidence of MACCE (Major adverse cardiac and cerebrovascular event) and patient's quality of life (QOL) at least 1 year after their surgery. MACCE will be assessed by contacting the patient's GP and/or Cardiologist and QOL questionnaire (SF12v2) will be sent to patients along with a patient information sheet. It is estimated that data collection would be completed within 3 months of start.
- Being tested
- Quality of Life Questionnaire, MACCE review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life QuestionnaireOther
Quality of Life Questionnaire will be completed at least 1 year after their surgery.
MACCE reviewOther
MACCE will be assessed by contacting the patient's GP and/or Cardiologist at least 1 year after their surgery.
| Study group | Role | What they receive |
|---|---|---|
| EVH | Patients that have undergone Endoscopic Vein Harvesting (EVH) Receives: Other: Quality of Life Questionnaire; Other: MACCE review | |
| OVH | Patients that have undergone open vein harvest (OVH) Receives: Other: Quality of Life Questionnaire; Other: MACCE review |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE in patients undergoing CABG where the LSV is harvested by EVH as compared to OVH
The review of MACCE will occur at least 1 year after the patient's operation
Measured: approximately 1 year
Secondary outcomes (3)
QOL as assessed by the SF12v2 questionnaire
The review of QOL will occur at least 1 year after the patient's operation
Measured: approximately 1 year
Time taken to return to regular daily activities
The review of time taken to return to regular daily activities will occur at least 1 year after the patient's operation
Measured: approximately 1 year
Survival
Measured: at approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startJul 2015
- Primary completion16 Oct 2015
- Study completion16 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications Due to Coronary Artery Bypass GraftStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- Maquet Cardiovascular
- Responsible party
- Sponsor
- Investigators
- Heyman Luckraz, Principal investigator, The Royal Wolverhampton NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471456
- Sponsor's protocol ID
- 2015CAR76
- Acronym
- MAQEH
- Status last verified
- Jun 2017
- First submitted
- 9 Jun 2015
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Major Adverse Cardiac and Cerebrovascular Event (MACCE) & Patients' Quality of Life (QOL) After Endoscopic Vein Harvesting as Compared to Open Vein Harvest for Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT02471456
- Acronym / sponsor ID
- MAQEH / 2015CAR76
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Collaborators
- Maquet Cardiovascular
- Study start
- Jul 2015 (actual)
- Primary completion
- 16 Oct 2015 (actual)
- Study completion
- 16 Oct 2015 (actual)
- First posted
- 15 Jun 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.
Most patients undergoing coronary artery bypass grafting (CABG) will require long saphenous vein (LSV) harvesting from the leg. This has been reported to be associated with a significant morbidity (leg swelling, pain, infection, bruising, wound discharge) in up to 50% of patients. Endoscopic vein harvesting (EVH) which has been reported to be associated with a reduction in these complications was implemented within the investigators' service in 2012. Although some initial reports of concerns regarding graft patency when the LSV is harvested by EVH, NICE and European Cardiology Society (ESC/EACTS) guidelines 2014 supported the use of the EVH technology. Last year a service evaluation in the investigators' department showed significant cost benefit of EVH as compared to open vein harvest (OVH) in a matched group (50 EVH and 50 OVH patients). The purpose of this study is to evaluate this group further to assess the incidence of MACCE (Major adverse cardiac and cerebrovascular event) and patient's quality of life (QOL) at least 1 year after their surgery. MACCE will be assessed by contacting the patient's GP and/or Cardiologist and QOL questionnaire (SF12v2) will be sent to patients along with a patient information sheet. It is estimated that data collection would be completed within 3 months of start.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVH | – | Other: Quality of Life Questionnaire, Other: MACCE reviewPatients that have undergone Endoscopic Vein Harvesting (EVH) |
| OVH | – | Other: Quality of Life Questionnaire, Other: MACCE reviewPatients that have undergone open vein harvest (OVH) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Fifty patients who underwent EVH (Study group) were part of our service evaluation when EVH was introduced to our practice. These patients were matched with patients undergoing CABG during the same period but where the LSV was harvested by OVH (50 patients, control group). This service evaluation showed a significant cost benefit when EVH was used in terms of reduction in the inhopsital stay, leg wound pain, leg wound infection and need to attend wound clinic. The current study is an extension of the service evaluation to assess how these patients are doing at least a year after their surgery in terms of MACCE, QOL,return to normal activities and survival
Key inclusion criteria (3 listed)
- Patient underwent CABG (isolated or combined) during period Jan 2012 to Dec 2013
- LSV harvested by EVH (Study group)
- LSV Harvested by OVH matched with EVH group (Control group)
Key exclusion criteria (1 listed)
- 1. Patient deceased at time of study start
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 |
|---|---|---|
| Quality of Life QuestionnaireQuality of Life Questionnaire will be completed at least 1 year after their surgery. | Other | EVH, OVH |
| MACCE reviewMACCE will be assessed by contacting the patient's GP and/or Cardiologist at least 1 year after their surgery. | Other | EVH, OVH |
Primary outcome
MACCE in patients undergoing CABG where the LSV is harvested by EVH as compared to OVH
Time frame: approximately 1 year
The review of MACCE will occur at least 1 year after the patient's operation
3 secondary outcomes
QOL as assessed by the SF12v2 questionnaire
Time frame: approximately 1 year
Time taken to return to regular daily activities
Time frame: approximately 1 year
Survival
Time frame: at approximately 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 21 Jun 2017.
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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.
Heyman Luckraz principal investigator
The Royal Wolverhampton NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complications Due to Coronary Artery Bypass Graft, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
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 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 21 Jun 2017. 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 United Kingdom. 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?
MACCE in patients undergoing CABG where the LSV is harvested by EVH as compared to OVH (time frame: approximately 1 year). 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 21 Jun 2017.