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

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. Identifier: NCT00500929
Recruitment Status : Completed
First Posted : July 13, 2007
Last Update Posted : March 25, 2009
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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 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
Actual Primary Completion Date : April 2008
Actual Study Completion Date : May 2008

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00500929

Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
Principal Investigator: Shaohua Wang, Dr. University of Alberta 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:
High risk

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases