Long Term Follow-up of Open Versus Endoscopic Radial Artery Harvest With CT Angiography
This study is enrolling participants by invitation only.
Sponsor:
Lawson Health Research Institute
Information provided by (Responsible Party):
Bob Kiaii, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01559376
First received: February 27, 2012
Last updated: March 19, 2012
Last verified: March 2012
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Purpose
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.
| Condition |
|---|
|
Arteriosclerosis of Arterial Coronary Artery Bypass Graft |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Long Term Follow-up of Open Versus Endoscopic Radial Artery Harvest With CT Angiography |
Resource links provided by NLM:
Further study details as provided by Lawson Health Research Institute:
Primary Outcome Measures:
- Radial artery graft patency [ Time Frame: Mean 5 years ] [ Designated as safety issue: No ]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 Outcome Measures:
- Ischemia present in other coronary artery territories [ Time Frame: Mean 5 years ] [ Designated as safety issue: No ]Areas of decreased perfusion identified by MPS-MIBI scanning in the context of CT - angiographic results
- Identification of left ventricular ejection fraction at rest and stress [ Time Frame: Mean 5 years ] [ Designated as safety issue: No ]Related in percentage of blood ejected as a fraction of left ventricular end diastolic volume
- Quality of life post CABG via the two questionnaires; the Seattle Angina Questionnaire (SAQ) and the 36-Item Short Form Health Survey. [ Time Frame: Mean 5 years ] [ Designated as safety issue: No ]Numerical score based on the questionnaire scoring scales
- Stenosis present in other coronary arteries / grafts [ Time Frame: Mean 5 year ] [ Designated as safety issue: No ]Based on CT - angiographic results. Grade A: 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
| Estimated Enrollment: | 118 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Endoscopic radial artery harvest |
| Conventional open radial artery harvest |
Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
The patient population consists of patients that have previously participated in our RCT from 2005-2007 with an open or endoscopically harvested radial artery graft used as a bypass conduit. We are following them for 5-year follow up.
Criteria
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:
- Expired
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559376
Locations
| Canada, Ontario | |
| London Health Sciences Centre, Victoria Hospital | |
| London, Ontario, Canada, N6A 5W9 | |
| London Health Sciences Centre, University Hospital | |
| London, Ontario, Canada, N6A 5A5 | |
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
| Principal Investigator: | Bob Kiaii, BSc, MD | University of Western Ontario, Lawson Research Institute, University of Western Ontario |
More Information
No publications provided
| Responsible Party: | Bob Kiaii, Associate Professor and Chair, Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT01559376 History of Changes |
| Other Study ID Numbers: | ENDO2012 |
| Study First Received: | February 27, 2012 |
| Last Updated: | March 19, 2012 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013