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

March 23, 2009 updated by: Cardiometabolics

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.

Study Overview

Status

Completed

Conditions

Heart Disease

Intervention / Treatment

Drug: CMI X-11S

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 2B7
    - University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ICU Time Time Frame: 30 to 45 days post-surgery	30 to 45 days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiometabolics

Investigators

Principal Investigator: Shaohua Wang, Dr., University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

July 12, 2007

First Submitted That Met QC Criteria