A Randomised Controlled Trial Comparing Conventional Coronary Artery Bypass Graft Surgery with a Composite Arterial Graft Technique

Record Provided by the NHSTCT Register - 2006 Update - Department of Health0 sites300 target enrollmentSeptember 29, 2006

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Enrollment: 300
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 29, 2006

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional

Investigators

Sponsor

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Eligibility Criteria

Inclusion Criteria

•300 patients will be recruited and randomly allocated in equal proportions to elective composite graft or conventional coronary artery bypass graft surgery. No randomised trials have been performed on all age groups of patients undergoing elective bypass surgery using composite graft techniques versus conventional bypass graft surgery. A recent randomised study comparing Saphenous vein grafts and radial artery conduits included angiographic follow\-up at 1 year. 4 Graft failure rates were comparable at around 15%. Assuming that LIMA failure rates are more favourable (2%) the proportion of failed distal anastomosis sites in 100 patients with 3 bottom ends would be 2 from LIMA failure and 30 from other conduits \- a rate of 32/300 or 10%. For patients with 4 bottom ends the figures would be 47/400 or 12%. If there is an equal proportion of 3 and 4 graft cases then a failure rate of 11% can be assumed for the conventional surgery group. From this data, a sample size of 300 patients would provide a denominator of 3\.5 x 300 \= 1050 anastomoses. Assuming 90% of patients yield angiographic images at follow\-up (allowing for death, failure to consent and angiographic problems) the study would have an 80% power to detect a failure rate of 17% in the composite group (alpha error \=0\.05\). Power for the angina outcome has been presented at the Seattle Questionnaire. All patients who fulfill the eligibility criteria will be approached by the participating surgeons and will be screened for trial eligibility. A patient information sheet will also be provided. Only patients who provide written informed consent prior to the procedure may be included. A copy of the written consent will be stored in the medical records, the study file and a copy will be given to the patient. The investigator will sign in the case record form that informed written consent has been obtained and the date consent was obtained. Informed consent will involve individual discussion with the patient about the nature of the procedures in a language that is easy to comprehend. The potential risks and benefits will be explained to the patient and they will be given time to make a decision about participation. It will be made clear that there is a random allocation to the two groups (composite versus conventional coronary artery bypass graft surgery) and that the patient or the physician does not decide which group they are allocated. It will be made clear that the patient can withdraw at any time from the research and does not have to give an explanation and it will not affect their medical care in any way. It will be recommended that the patient is given 24 hours to think about participation and discussing with family, friends or other healthcare professionals before signing the consent form. Referral to a participating surgeon for isolated multi\-vessel CABG with an intention to fashion at least three distal anastomosis sites.

Exclusion Criteria

•1\. Any contraindication to trial entry based on the clinical judgment of the responsible surgeon eg anticipated difficulty in surgical access, surgery planned as an emergency CABG on admission, and patients on inotropic support or cardiogenic shock
•2\. Re\-operation
•3\. Proposed surgical or other intervention on a cardiac valve, great vessel, myocardial substance or other cardiovascular structure
•4\. Previous CVA/TIA within the last 6 months
•5\. Significant problem with graft material eg inability to use IMA graft, or absence of graft conduit material
•6\. Intention to perform bilateral IMA pedicle grafts
•7\. High risk of complication from subsequent follow\-up diagnostic cardiac catheterisation including peripheral vascular disease, established renal dysfunction (serum creatinine \>200 µmol/L or functioning transplant), allergy to radiographic contrast and previous angiographic complication or difficulty.
•8\. Recent involvement in another study (past 30 days etc)