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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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00500929     History of Changes
Other Study ID Numbers: CMI X-11S-G-1
Study First Received: July 12, 2007
Last Updated: March 23, 2009
Health Authority: Canada: Health Canada

Keywords provided by Cardiometabolics:
OHSP
High risk
Geriatrics

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013