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

This study has been completed.
Sponsor:
Information provided by:
Cardiometabolics
ClinicalTrials.gov Identifier:
NCT00500929
First received: July 12, 2007
Last updated: March 23, 2009
Last verified: March 2009

July 12, 2007
March 23, 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
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00500929
CMI X-11S-G-1
Yes
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