Back to resultsA Clinical Trial in Higher Risk Geriatric Patients Undergoing OHSP (MiniMetrxics)
Primary Purpose
Heart Disease
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
CMI X-11S
Sponsored by
About this trial
This is an interventional treatment trial for Heart Disease focused on measuring OHSP, High risk, Geriatrics
Eligibility 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
Sites / Locations
- University of Alberta
Outcomes
Primary Outcome Measures
ICU Time
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00500929
Brief Title
A Clinical Trial in Higher Risk Geriatric Patients Undergoing OHSP
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cardiometabolics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease
Keywords
OHSP, High risk, Geriatrics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
CMI X-11S
Primary Outcome Measure Information:
Title
ICU Time
Time Frame
30 to 45 days post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaohua Wang, Dr.
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
12. IPD Sharing Statement
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A Clinical Trial in Higher Risk Geriatric Patients Undergoing OHSP
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