Back to Functional Life Following Cardiac Surgery | NCT01586585

Studies
Back to Functional Life Following Cardiac Surgery

NCT01586585

Sponsor

Carmel Medical Center

Status

Withdrawn

Last Update Posted

Oct 24, 2013Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Cardiac Study Patients

Interventions

Not provided

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

Oct 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Apr 22, 2012

First Submission Date that Met QC Criteria

Apr 26, 2012

First Posted Date

Apr 27, 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

Oct 23, 2013

Last Update Posted Date

Oct 24, 2013Estimated

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 investigators will monitor cardiac patients rehabilitation post op upon their pre op status.

Detailed Description

In this work we will try to monitor the patients for a longer period, starting from their hospitalization period through their rehabilitation period up to 18 months post their discharge from the hospital.

Many studies tried to evaluate different ways to predict postoperative complications following cardiac surgery, patient's survival, rehabilitation rate and duration. Today, following these studies doctors use different methods to evaluate these parameters. The Society of Thoracic Surgeons mortality risk score (STS) and the European System for Cardiac Operative Risk Evaluation (EuroSCORE) scoring system are the two most frequently used risk profile systems within the United States and Europe. The STS score is comprised of over 40 clinical parameters, whereas the EuroSCORE involves 18 clinical characteristics that comprises three categories, each weighted accordingly. Studies published recently suggest that a combination of a new frailty score and the traditional scoring systems may facilitate a more accurate risk scoring in elderly high-risk patients scheduled for conventional cardiac surgery or trans-catheter aortic valve replacement.

In this study we will try to evaluate the contribution of using a frailty score index in addition to the EuroSCORE evaluation in patients≥50 years of age, in prediction of postoperative complications following cardiac surgery.

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

Label	Type	Description	Intervention Names
post cardiac surgery patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of time taken to the patient to get back to functional life	The back to functional life period will be estimated using questionnaires that will be filled by the patient before the operation and in intervals after the operation	3 years

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events stratified by Frailty index	The patients will go through different tests in order to estimate their fragility index, their post op complications will be monitored, and we will try to find association between the frailty index and severity and number of complications	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing cardiothoracic surgery in the Cardiothoracic Surgery Department at Carmel Medical center, Haifa, Israel, between: 1.5.12-28.2.14.
Patients ≥ 50 years of age
Informed consent from each participant that can understand, read and sign the informed consent form.

Exclusion Criteria:

Emergent surgery, defined as a surgery for which there should be no delay due to ongoing refractory cardiac compromise.
Clinical instability, defined as active coronary ischemia, decompensated heart failure not yet stabilized, or any acute process causing significant symptoms or abnormal vital signs.
Severe neuropsychiatric condition causing inability to cooperate with the study procedures.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Cardiac surgery patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yaron Barac, MD/PhD	Cramel Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carmel Medical Center		Haifa			Israel