Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Back to Functional Life Following Cardiac Surgery (BTFL2012)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01586585
First received: April 22, 2012
Last updated: October 23, 2013
Last verified: October 2013

April 22, 2012
October 23, 2013
May 2012
September 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01586585 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Back to Functional Life Following Cardiac Surgery
Patient Rehabilitation Post Cardiac Surgery Based on Their Pre-op Status

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Cardiac surgery patients

Cardiac Study Patients
Not Provided
post cardiac surgery patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2013
September 2013   (final data collection date for primary outcome measure)

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.
Both
50 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01586585
CMC-12-0021-CTIL
No
Carmel Medical Center
Carmel Medical Center
Not Provided
Principal Investigator: Yaron Barac, MD/PhD Cramel Medical Center
Carmel Medical Center
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP