A Clinical Trial in Higher Risk Geriatric Patients Undergoing OHSP

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00500929

Acronym

MiniMetrxics

Enrollment

Registered

2007-07-13

Start date

2007-07-31

Completion date

2008-05-31

Last updated

2009-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Disease

Keywords

OHSP, High risk, Geriatrics

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.

Interventions

DRUGCMI X-11S

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
ICU Time	30 to 45 days post-surgery

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026