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Back to Functional Life Following Cardiac Surgery (BTFL2012)

This study is not yet open for participant recruitment.
Verified April 2012 by Carmel Medical Center
Sponsor:
Information provided by (Responsible Party):
Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01586585
First received: April 22, 2012
Last updated: April 26, 2012
Last verified: April 2012
History of Changes
  Purpose

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


Condition
Cardiac Study Patients

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Rehabilitation Post Cardiac Surgery Based on Their Pre-op Status

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • Length of time taken to the patient to get back to functional life [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Number of Participants with Adverse Events stratified by Frailty index [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 2000
Study Start Date: May 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
post cardiac surgery patients

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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cardiac surgery patients

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Emergent surgery, defined as a surgery for which there should be no delay due to ongoing refractory cardiac compromise.
  2. Clinical instability, defined as active coronary ischemia, decompensated heart failure not yet stabilized, or any acute process causing significant symptoms or abnormal vital signs.
  3. Severe neuropsychiatric condition causing inability to cooperate with the study procedures.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01586585

Contacts
Contact: Yaron Barac, MD/PhD +97250725993 byaron@tx.technion.ac.il

Locations
Israel
Carmel Medical Center Not yet recruiting
Haifa, Israel
Contact: Yaron Barac, MD/PhD     +972507259933     Byaron@tx.technion.ac.il    
Principal Investigator: Yaron Barac, MD/PhD            
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Yaron Barac, MD/PhD Cramel Medical Center
  More Information

No publications provided

Responsible Party: Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01586585     History of Changes
Other Study ID Numbers: CMC-12-0021-CTIL
Study First Received: April 22, 2012
Last Updated: April 26, 2012
Health Authority: Israel: Ethics Commission

ClinicalTrials.gov processed this record on June 18, 2013