A Clinical Trial in Higher Risk Geriatric Patients Underg... | NCT00500929

Studies
A Clinical Trial in Higher Risk Geriatric Patients Undergoing OHSP

NCT00500929

Sponsor

Cardiometabolics

Status

Completed

Last Update Posted

Mar 25, 2009Estimated

Enrollment

80Estimated

Phase

Phase 2

Conditions

Heart Disease

Interventions

CMI X-11S

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Apr 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Jul 12, 2007

First Submission Date that Met QC Criteria

Jul 12, 2007

First Posted Date

Jul 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2009

Last Update Posted Date

Mar 25, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Name	Type	Description	Arm Group Labels	Other Names
CMI X-11S	Drug

Measure	Description	Time Frame
ICU Time		30 to 45 days post-surgery

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shaohua Wang, Dr.	University of Alberta	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alberta		Edmonton	Alberta	T6G 2B7	Canada