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

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ClinicalTrials.gov Identifier: NCT00500929
Recruitment Status : Completed
First Posted : July 13, 2007
Last Update Posted : March 25, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Heart Disease Drug: CMI X-11S Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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)
Study Start Date : July 2007
Primary Completion Date : April 2008
Study Completion Date : May 2008
Arms and Interventions


Outcome Measures

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

Eligibility Criteria

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 Posted: July 13, 2007    Key Record Dates
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