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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
July 12, 2007
July 13, 2007
March 25, 2009
July 2007
April 2008   (Final data collection date for primary outcome measure)
ICU Time [ Time Frame: 30 to 45 days post-surgery ]
Same as current
Complete list of historical versions of study NCT00500929 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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A Clinical Trial in Higher Risk Geriatric Patients Undergoing OHSP
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)
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Heart Disease
Drug: CMI X-11S
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
May 2008
April 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
70 Years and older   (Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00500929
CMI X-11S-G-1
Yes
Not Provided
Not Provided
Not Provided
Cardiometabolics
Not Provided
Principal Investigator: Shaohua Wang, Dr. University of Alberta
Cardiometabolics
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP