Long Term Follow-up of Robotic Assisted Surgical Revascularization (ZEUSFUPCTA)
This study is enrolling participants by invitation only.
Sponsor:
Lawson Health Research Institute
Collaborator:
London Health Sciences Centre
Information provided by (Responsible Party):
Bob Kiaii, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00774865
First received: October 15, 2008
Last updated: February 13, 2012
Last verified: February 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The objectives of the 2-year study are two-fold:
- To determine the 5-7 year patency rate (rate of open bypass grafts) of the LITA graft of patients who have already had robotically-assisted CABG surgery using CTA and MPS-MIBI
- To determine patient quality of life at 5-7 years after robotically-assisted CABG surgery
| Condition | Intervention |
|---|---|
|
Coronary Artery Disease |
Procedure: MIBI and CTA |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Long Term Follow-up of Robotic Assisted Surgical Revascularization With CT Angiography |
Resource links provided by NLM:
Further study details as provided by Lawson Health Research Institute:
Primary Outcome Measures:
- To determine the 5-7 year patency rate of the LITA graft of patients who have already had robotically-assisted CABG surgery using CTA and MPS-MIBI [ Time Frame: 5-7 years post robotic assisted CABG ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine patient quality of life at 5-7 years after robotically-assisted CABG surgery [ Time Frame: 5-7 years post robotic assisted CABG ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Surgical
Patients who have previously undergone robotic bypass surgery
|
Procedure: MIBI and CTA
Rest and Stress MIBI and CT Angiography
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
All 150 living robotically-assisted CABG surgery patients will 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.
Criteria
Inclusion Criteria:
- Have had previous robotically-assisted CABG surgery with a LITA to LAD anastomosis with either AESOP or Zeus performed between September 1999 and December 2001 at the London Health Sciences Centre
- Willing to give informed consent to participate in the study
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774865
Locations
| Canada, Ontario | |
| London Health Sciences Centre | |
| London, Ontario, Canada, N6A 5A5 | |
Sponsors and Collaborators
Lawson Health Research Institute
London Health Sciences Centre
Investigators
| Principal Investigator: | Bob Kiaii, MD, FRCSC | London Health Sciences Centre |
More Information
No publications provided
| Responsible Party: | Bob Kiaii, Chair/Chief Cardiac Surgery, LHSC, University Hospital, Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT00774865 History of Changes |
| Other Study ID Numbers: | R-08-190, 15000 |
| Study First Received: | October 15, 2008 |
| Last Updated: | February 13, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Lawson Health Research Institute:
|
Robotic CABG LITA |
Patency Long Term |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013