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

Cardiometabolics

Status and phase: Completed; Phase 2

Conditions: Heart Disease

Treatments: Drug: CMI X-11S

Study type: Interventional

Funder types: Industry

Identifiers

NCT00500929

CMI X-11S-G-1

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind