Optima Coronary Artery Disease (CAD) (Optimal Mechanical... | NCT00896142

Studies
Optima Coronary Artery Disease (CAD) (Optimal Mechanical Evaluation)

NCT00896142

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Nov 22, 2011Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Heart Failure
Ischemic Cardiomyopathy

Interventions

Not provided

Countries

United States

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

Nov 2011

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

Oct 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 8, 2009

First Submission Date that Met QC Criteria

May 8, 2009

First Posted Date

May 11, 2009Estimated

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

Nov 21, 2011

Last Update Posted Date

Nov 22, 2011Estimated

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Ischemic Cardiomyopathy
Left ventricular ejection fraction less than 40%
Clinical indication for invasive electrophysiology testing
Patient is at least 18 years of age

Exclusion Criteria

Unstable angina, acute myocardial infarction and/or revascularization procedure within 3 months
CVA or TIA within the past 6 months
Prosthetic heart valve
Patient is status post heart transplant
Women who are pregnant or with child -bearing potential and who are not on a reliable form of birth control. Women of child-bearing potential are routinely tested for pregnancy as part of the standard of care prior to EPS procedures being performed.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

18+ years of age must be patients of UPMC Cardiovascular Institute

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David S. Schwartzman, MD	University of Pittsburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UPMC Presybterian		Pittsburgh	Pennsylvania	15213	United States

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases