The Short Form-36: Pre- Versus Post-Surgical Administrati... | NCT00226265

Studies
The Short Form-36: Pre- Versus Post-Surgical Administration in Cardiac Surgery Patients

NCT00226265

Sponsor

Weill Medical College of Cornell University

Status

Completed

Last Update Posted

Feb 23, 2017Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Coronary Artery Bypass Grafting
Heart Diseases
Heart Valve Diseases

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

Feb 2017

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

Jan 1999Actual

Primary Completion Date

Dec 2006Actual

Completion Date

Sep 2007Actual

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 22, 2005

First Posted Date

Sep 26, 2005Estimated

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

Feb 17, 2017

Last Update Posted Date

Feb 23, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mary E. Charlson, MD, Principal Investigator, Weill Medical College of Cornell UniversityPrincipal Investigator

Lead Sponsor

Weill Medical College of Cornell UniversityOTHER

Collaborators

Not provided

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

The purpose of this study is to determine whether the SF-36 can be administered reliably to cardiac surgery patients (two to three days) post-surgery, with the patient answering the questions of this survey from a pre-surgical perspective.

Detailed Description

The purpose of this study, is to determine whether the SF-36 can be administered reliably to cardiac surgery patients (two to three days) post-surgery, with the patient answering the questions of this survey from a pre-surgical perspective.

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:

Cardiac surgery patients who are between the ages of 18 and 100
Are English speaking
Able to give consent
Undergoing cardiac surgery including (but not limited to):
- Aortic valve replacement (AVR)
- Mitral valve replacement (MVR)
- Tricuspid valve replacement (TVR)
- Coronary artery bypass graft (CABG).

Exclusion Criteria:

Non-cardiac surgery patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Cardiac Surgery Patients at New York Presbyterian Hospital-Weill Cornell Medical College

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mary E Charlson, MD	Weill Medical College of Cornell University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The New York Presbyterian Hospital-Weill Medical Center		New York	New York	10021	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

No Plan to Share IPD

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006331	Heart Diseases
D006349	Heart Valve Diseases

Ancestor Terms

ID	Term
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided