Long Term Follow-up of Open Versus Endoscopic Radial Artery Harvest With CT Angiography
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 118
- Locations
- 2
- Primary Endpoint
- Radial artery graft patency
Study Overview
Brief Summary
The objectives of the study are two-fold:
- To determine the mean 5 year patency rate of the radial artery graft (Open vs. Endoscopic) of patients who have already had CABG surgery and who previously participated in the centre's RCT back in 2005-2007 using CTA and MPS-MIBI
- To determine patient quality of life at 5 years post CABG surgery
It is hypothesized that the mean 5 year patency rate of the radial artery graft harvested endoscopically will be equal to or have greater patency than the radial artery graft harvested via the conventional/open technique. It is further hypothesized that patient quality of life will be similar amongst patients having had the open vs. endoscopic radial artery graft during CABG surgery.
Detailed Description
After patient consent and REB approval from The University of Western Ontario (REB # 11054) we conducted a Randomized Controlled Trial between 2005-2007 of endoscopic vs. conventional harvesting of the radial artery in CABG patients at the London Health Sciences Centre. A total of 118 patients were randomized to either A) conventional/open harvesting of the radial artery, n=59 or B) endoscopic harvesting of the radial artery, n=59. Post-operative study objectives measured were arm wound infection rate, assessment of arm pain, arm edema, mobilization, patient satisfaction, and histological assessment of the radial artery. Objectives were measured during the patients' course in-hospital and at 1week by telephone interview. At 6 weeks patient underwent a final clinic assessment post-surgery.
Our intent is to perform follow-up angiography and MPS-MIBI at the 5 year mark post surgery on the 118 patients previously involved in our RCT, to assess open vs. endoscopic radial artery graft performance. The study will be divided into three phases: Phase I - Patient Recruitment (4 months), Phase II - Patient Assessment with CTA, MPS-MIBI and Questionnaires (16 months) and Phase III - Data Analysis and Conclusions (4 months).
Phase I - Chart Review and Patient Recruitment (4 Months) Charts will be reviewed on all of the open and endoscopically harvested radial artery grafts used during CABG surgery from the above specified time points. Patient demographics and operative notes, as well as perioperative and postoperative complications will be reviewed. Hospital admissions, documented cardiac events and any subsequent deaths not previously documented will be recorded. Any additional pertinent data from the chart review will be entered into a study specific Microsoft Excel file maintained by a single qualified research assistant.
All living CABG surgery patients will then be contacted and their participation in the study requested. Patients will receive an initial request by mail, with an informative letter signed by the principal investigator outlining the purpose of the study, what participation in the study involves, and the specific aims of the cardiac team at the conclusion of the study. A follow-up phone call will be done within 3-weeks of mailing the letter to go over the content and answer any questions that patients may have.
Phase II - Patient Assessment via CTA, MPS-MIBI and Questionnaires (16 Months)
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients will be included if they:
- •Have previously participated in our RCT from 2005-2007 with an open or endoscopically harvested radial artery graft used as a bypass conduit.
- •Willing to give informed consent to participate in the study
Exclusion Criteria
- •Patients are excluded if they are:
- •Unable or unwilling to give informed consent
- •History of allergic reaction to contrast material used in CTA or severe adverse reactions to medications used in MPS-MIBI procedures
- •Kidney dysfunction
Outcomes
Primary Outcomes
Radial artery graft patency
Time Frame: Mean 5 years
Grade A Excellent graft with unimpaired run-off, patent graft Grade B Stenosis reducing caliber of proximal, distal anastomosis or trunk to \<50% of the grafted coronary artery. This will be divided into flow limiting and non-flow limiting stenosis Grade O Occlusion
Secondary Outcomes
- Ischemia present in other coronary artery territories(Mean 5 years)
- Quality of life post CABG via the two questionnaires; the Seattle Angina Questionnaire (SAQ) and the 36-Item Short Form Health Survey.(Mean 5 years)
- Identification of left ventricular ejection fraction at rest and stress(Mean 5 years)
- Stenosis present in other coronary arteries / grafts(Mean 5 year)