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NCT00500929 Clinical Trial

A Clinical Trial in Higher Risk Geriatric Patients Undergoing OHSP

Heart Disease Clinical Trial

— MiniMetrxics  

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00500929
Other study ID # CMI X-11S-G-1
Secondary ID
Status Completed
Phase Phase 2
First received July 12, 2007
Last updated March 23, 2009
Start date July 2007
Est. completion date May 2008

Study information
Verified date March 2009
Source Cardiometabolics
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date May 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Both
Age group 70 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• CMI X-11S

Locations
Country Name City State
Canada University of Alberta Edmonton Alberta

Sponsors (1)
Lead Sponsor Collaborator
Cardiometabolics

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary ICU Time 30 to 45 days post-surgery
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