- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01586585
Back to Functional Life Following Cardiac Surgery (BTFL2012)
Patient Rehabilitation Post Cardiac Surgery Based on Their Pre-op Status
Study Overview
Status
Conditions
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
Contacts and Locations
Study Locations
-
-
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Haifa, Israel
- Carmel Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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post cardiac surgery patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yaron Barac, MD/PhD, Cramel Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CMC-12-0021-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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