Back to Functional Life Following Cardiac Surgery

Cardiac Study Patients Clinical Trial

— BTFL2012  

Official title:

Patient Rehabilitation Post Cardiac Surgery Based on Their Pre-op Status

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01586585
• Other study ID #: CMC-12-0021-CTIL
• Status: Withdrawn
• Phase: N/A
• First received: April 22, 2012
• Last updated: October 23, 2013
• Start date: May 2012
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Study Patients

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No