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Completed

NCT Number: NCT00500929

A Clinical Trial in Higher Risk Geriatric Patients Undergoing 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.

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Key information

Conditions

Heart Disease Cardiovascular Diseases Heart Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CMI X-11S

Drug

Primary outcomes

  1. ICU Time

    Time frame: 30 to 45 days post-surgery

Sponsors and collaborators

Lead sponsor

Cardiometabolics

Industry

Registry information

Official study 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)

Acronym: MiniMetrxics

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 13, 2007
Registry last updated
Mar 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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