Long Term Follow-up of Robotic Assisted Surgical Revascularization - Full Text View

Sponsored by:	Lawson Health Research Institute
Information provided by:	Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00774865

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

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Long Term Follow-up of Robotic Assisted Surgical Revascularization With CT Angiography

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	150
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	June 2010 (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

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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

Investigators

Principal Investigator:

Bob Kiaii, MD, FRCSC

London Health Sciences Centre

More Information

Responsible Party:	London Health Sciences Centre, University Hospital ( Dr. Bob Kiaii )
Study ID Numbers:	R-08-190, 15000
Study First Received:	October 15, 2008
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00774865
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:

Robotic
CABG
LITA

Patency
Long
Term

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009