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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 25, 2014