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Long Term Follow-up of Robotic Assisted Surgical Revascularization (ZEUSFUPCTA)

This study is enrolling participants by invitation only.
Sponsor:
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: October 7, 2013
Last verified: October 2013
  Purpose

The objectives of the 2-year study are two-fold:

  1. 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
  2. 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

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 2014
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:

  1. 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
  2. Willing to give informed consent to participate in the study

Exclusion Criteria:

  1. Expired
  2. Unable or unwilling to give informed consent
  3. History of allergic reaction to contrast material used in CTA or severe adverse reactions to medications used in MPS-MIBI procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 7, 2013
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
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014