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A Clinical Trial in Higher Risk Geriatric Patients Undergoing OHSP (MiniMetrxics)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00500929
First Posted: July 13, 2007
Last Update Posted: March 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cardiometabolics
  Purpose
To provide information on parameters needed to design a subsequent Phase III confirmatory trial and to assess the safety and efficacy of the acute use of CMI X-11S in high-risk geriatric patients undergoing open-heart surgical procedures (OHSP) requiring cardio-pulmonary bypass.

Condition Intervention Phase
Heart Disease Drug: CMI X-11S Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Mini-Metrxics: A Single-Centre, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Clinical Trial of CMI X-11S in Higher Risk Geriatric Patients Undergoing Open-Heart Surgical Procedures (OHSP)

Further study details as provided by Cardiometabolics:

Primary Outcome Measures:
  • ICU Time [ Time Frame: 30 to 45 days post-surgery ]

Estimated Enrollment: 80
Study Start Date: July 2007
Study Completion Date: May 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Requirement for open-heart (including emergency) surgical procedures requiring cardio-pulmonary bypass:

    • Either:

      • Age ≥ 70 to <80 with a Parsonnet Mortality Risk Score of ≥13 (poor risk); OR
      • Age ≥ 80
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500929


Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
Cardiometabolics
Investigators
Principal Investigator: Shaohua Wang, Dr. University of Alberta
  More Information

ClinicalTrials.gov Identifier: NCT00500929     History of Changes
Other Study ID Numbers: CMI X-11S-G-1
First Submitted: July 12, 2007
First Posted: July 13, 2007
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by Cardiometabolics:
OHSP
High risk
Geriatrics

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases