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Back to Functional Life Following Cardiac Surgery (BTFL2012)

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ClinicalTrials.gov Identifier: NCT01586585
Recruitment Status : Withdrawn
First Posted : April 27, 2012
Last Update Posted : October 24, 2013
Sponsor:
Information provided by (Responsible Party):
Carmel Medical Center

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

Condition or disease
Cardiac Study 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.


Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Rehabilitation Post Cardiac Surgery Based on Their Pre-op Status
Study Start Date : May 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort
post cardiac surgery patients



Primary Outcome Measures :
  1. Length of time taken to the patient to get back to functional life [ Time Frame: 3 years ]
    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 :
  1. Number of Participants with Adverse Events stratified by Frailty index [ Time Frame: 3 years ]
    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



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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01586585


Locations
Israel
Carmel Medical Center
Haifa, Israel
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Yaron Barac, MD/PhD Cramel Medical Center

Responsible Party: Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01586585     History of Changes
Other Study ID Numbers: CMC-12-0021-CTIL
First Posted: April 27, 2012    Key Record Dates
Last Update Posted: October 24, 2013
Last Verified: October 2013