Cardiac Study PatientsBTFL2012NCT01586585
Back to Functional Life Following Cardiac Surgery
An observational study of Cardiac Study Patients, run by Carmel Medical Center at 1 site in Israel.
Trial summary
The investigators will monitor cardiac patients rehabilitation post op upon their pre op status. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Cardiac Study Patients
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- May 2012to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiac surgery patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Study Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| post cardiac surgery patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (1)
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Study PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yaron Barac, MD/PhD, Principal investigator, Cramel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586585
- Sponsor's protocol ID
- CMC-12-0021-CTIL
- Acronym
- BTFL2012
- Status last verified
- Oct 2013
- First submitted
- 22 Apr 2012
- Last updated
- 24 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Rehabilitation Post Cardiac Surgery Based on Their Pre-op Status
- ClinicalTrials.gov ID
- NCT01586585
- Acronym / sponsor ID
- BTFL2012 / CMC-12-0021-CTIL
- Conditions
- Cardiac Study Patients
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 27 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will monitor cardiac patients rehabilitation post op upon their pre op status.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| post cardiac surgery patients | – | – |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac surgery patients
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Number of Participants with Adverse Events stratified by Frailty index
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaron Barac, MD/PhD principal investigator
Cramel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Study Patients, run by Carmel Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of time taken to the patient to get back to functional life (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2013; AzTrials last refreshed its copy on 6 Nov 2026.