Retrospective Review of Management of Infective Endocarditis | NCT00579761

Studies
Retrospective Review of Management of Infective Endocarditis

NCT00579761

Sponsor

Virginia Commonwealth University

Status

Withdrawn

Last Update Posted

Dec 14, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Endocarditis

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

Dec 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Per PI on 12/9/15 - No patients were ever enrolled in this study

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 17, 2007

First Submission Date that Met QC Criteria

Dec 21, 2007

First Posted Date

Dec 24, 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

Dec 10, 2015

Last Update Posted Date

Dec 14, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

This is an analysis of the outcomes of patients having undergone surgical intervention for infective endocarditis.

Detailed Description

This study will look at the presentations, epidemiology, risk factors, modalities of diagnosis; and the role of specific investigatory tools with surgical intervention and timimg of intervention in patients who underwent surgical treatment for infective endocarditis. Morbidity and Mortality post surgery and prognosis including long term outcome of our patients will be analyzed. Special attention will be made to those patients with pre-operative neurological deficit.

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

0Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have undergone surgical treatment for infective endocarditis

Exclusion Criteria:

Less than 18 years old

Accepts Healthy Volunteers

Yes

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

All subjects that have undergone surgical treatment for infective endocarditis at VCU medical Center from 1996 to present

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vigneshwar Kasirajan, MD	Virginia Commonwealth University Department of Cardiothoracic Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Commonweath University MCV Hospital		Richmond	Virginia	23298	United States

Condition Browse Module

MeSH Terms

ID	Term
D004696	Endocarditis
D009461	Neurologic Manifestations

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided