Mid-term Survival and Quality of Life of Elderly Patients... | NCT01654900

Studies
Mid-term Survival and Quality of Life of Elderly Patients Undergoing Open Heart Surgery

NCT01654900

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Aug 1, 2012Estimated

Enrollment

207Estimated

Phase

Not provided

Conditions

Quality of Life

Interventions

No intervention in this study

Countries

Israel

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

Jul 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 16, 2012

First Submission Date that Met QC Criteria

Jul 31, 2012

First Posted Date

Aug 1, 2012Estimated

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

Jul 31, 2012

Last Update Posted Date

Aug 1, 2012Estimated

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 purposes of the investigators study is to examine the overall survival and quality of life in elderly patients (> 75 years) undergoing open heart surgery at Hadassah medical center between 2008-2011. All alive patients will be phone interviewed using the 36-item short form health survey. Results will be compared to similar health survey results (36-SF)obtained from a group of Israeli adults who had no open heart surgery (controlled group). The investigators hypothesize that elderly patients achieve improvement in quality of life after open heart surgery with acceptable operative morbidity and mortality.

Detailed Description

Not provided

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

207Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients age >75 y who underwent open hear surgeary		The cohort study consist of all patients > 75 y, undergoing open heart surgery between 2008-2011 at Hadassah medical center.	Other: No intervention in this study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention in this study	Other		Patients age >75 y who underwent open hear surgeary

Measure	Description	Time Frame
Quality of life		2-4 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients age > 75 years who discharged alive after surgery

Exclusion Criteria:

death

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

All patients age >75 y who underwent open heart surgery between 2008-2011 at hadassah medical center.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Oz Shapira, MD	Contact	00 972 2 6776960		ozshapira@hadassah.org.il
Hadas Lemberg, PhD	Contact	00 972 2 6777572		lhadas@hadassah.org.il

Overall Officials

Name	Affiliation	Role
Oz Shapira, MD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem	Ein Kerem	91120	Israel