Coronary Heart DiseaseFOCuSNCT02749149
Does Frailty Help Predict Postoperative Outcomes in Cardiac Surgery?
An observational study of Coronary Heart Disease and Heart Valve Diseases, run by King's College Hospital NHS Trust.
Trial summary
This study will assess the benefit in using a frailty score to quantify accurate risk pre-operatively in patients undergoing major cardiac surgery in order to predict morbidity and disability-free survival post-operatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, Heart Valve Diseases
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jun 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators are planning to recruit 120 adult patients undergoing elective coronary artery bypass graft (CABG); valve replacement/repair; or transcatheter aortic valve implantation (TAVI) surgery at King's College Hospital, Denmark Hill, London
Who may be able to join
- Aged 18 years or over
- Due to undergo elective cardiac surgery: coronary artery bypass graft (CABG); valve replacement/repair; or transcatheter aortic valve implantation (TAVI) surgery
- Able to give informed consent
- Fluency in English
Who cannot join
- Emergency cardiac surgery and non-cardiac surgery
- Inadequate knowledge of English that will prevent patients from completing the consent or undertaking study assessments
- Severe visual, auditory, or motor handicap
- Concurrent diseases of the central nervous system,
- Patients at the extremes of frailty, in whom it would be unethical to perform a full assessment.
About this study
Official title: Assessment of the Frailty Score in Cardiac Surgery and Its Correlation to Cardiac Postoperative Morbidity and Disability - a Prospective Observational Study
This study will assess the benefit in using a frailty score to quantify accurate risk pre-operatively in patients undergoing major cardiac surgery in order to predict morbidity and disability-free survival post-operatively.
Read the detailed description
Increasingly, the group of patients undergoing cardiac surgery are older. Patients that are more elderly and frail are known to have an increase risk of injury to major organs following surgery including the heart, kidneys, and brain, all of which are associated with worse survival or diminished quality of life. It is becoming more important to be able to predict how well patients will fair in cardiac surgery, including predicting risk of complications (such as stroke or heart attacks) as well as long-term survival and quality of life. Currently, scores such as EUROscore can be used with good effect in predicting survival and major complications in cardiac surgery patients. However, frailty - the severity of a patient's weakness or fragility - has emerged as a potential candidate in predicting risk. Recent research has shown frailty score to predict risk of survival and complications following cardiac surgery and suggested to be possibly superior to pre-existing scores. The investigators wish to investigate the possible link between frailty and outcomes following cardiac surgery, in addition to current risk scores. The investigators also wish to determine whether frailty can effectively predict longer-term outcomes such as 'disability-free survival' - a patient-centred score that measures the ability of a patient to lead normal life activities. Patients undergoing major cardiac surgery at King's College Hospital will be recruited, following consent. The study will mainly involve questionnaires at various stages, starting at a pre-operative clinic. After surgery, follow up of patient's progress will be carried out at 3 days in hospital; and at 1 month, 3 months, and 6 months and 1 year via telephone. The investigators expect the results of this observational study to influence further research into the use of frailty risk scoring prior to clinical decisions, and add to the evidence in assessing risk-related outcomes in cardiac surgery.
- Conditions
- Coronary Heart Disease, Heart Valve Diseases
- Keywords
- Cardiac, Surgery, Frailty, Frail, Patients, Recovery, Morbidity, Outcomes, Mortality, Heart, Perioperative, Disability, WHODAS
- Medical subject headings
- Coronary Disease, Heart Valve Diseases, Frailty
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 |
|---|---|---|
| Cardiac Surgery | Patients undergoing cardiac surgery: coronary artery bypass graft (CABG); valve replacement/repair; or transcatheter aortic valve implantation (TAVI) surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability-free survival
Defined as percentage of participants alive and with a disability score (using World Health Organisation Disability Assessment Schedule 2.0, WHODAS) of less than 25%.
Measured: 1 year
Secondary outcomes (5)
Mortality
Measured: 1 month postoperative
Delirium
Using Confusion Assessment Method (CAM).
Measured: 3 days postoperative
In hospital complications
Incidence of major adverse cardiac or cerebrovascular events, and/or acute renal injury.
Measured: 1 month
Return to theatre
Measured: 1 month
Length of hospital stay
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Lucas de Carvalho, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749149
- Sponsor's protocol ID
- KCH16-012
- Acronym
- FOCuS
- Status last verified
- Apr 2016
- First submitted
- 8 Apr 2016
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Contact research lead.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Frailty Score in Cardiac Surgery and Its Correlation to Cardiac Postoperative Morbidity and Disability - a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02749149
- Acronym / sponsor ID
- FOCuS / KCH16-012
- Conditions
- Coronary Heart Disease, Heart Valve Diseases
- Keywords
- Cardiac, Surgery, Frailty, Frail, Patients, Recovery, Morbidity, Outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 22 Apr 2016 (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.
This study will assess the benefit in using a frailty score to quantify accurate risk pre-operatively in patients undergoing major cardiac surgery in order to predict morbidity and disability-free survival post-operatively.
Detailed description
Increasingly, the group of patients undergoing cardiac surgery are older. Patients that are more elderly and frail are known to have an increase risk of injury to major organs following surgery including the heart, kidneys, and brain, all of which are associated with worse survival or diminished quality of life. It is becoming more important to be able to predict how well patients will fair in cardiac surgery, including predicting risk of complications (such as stroke or heart attacks) as well as long-term survival and quality of life. Currently, scores such as EUROscore can be used with good effect in predicting survival and major complications in cardiac surgery patients. However, frailty - the severity of a patient's weakness or fragility - has emerged as a potential candidate in predicting risk. Recent research has shown frailty score to predict risk of survival and complications following cardiac surgery and suggested to be possibly superior to pre-existing scores. The investigators wish to investigate the possible link between frailty and outcomes following cardiac surgery, in addition to current risk scores. The investigators also wish to determine whether frailty can effectively predict longer-term outcomes such as 'disability-free survival' - a patient-centred score that measures the ability of a patient to lead normal life activities. Patients undergoing major cardiac surgery at King's College Hospital will be recruited, following consent. The study will mainly involve questionnaires at various stages, starting at a pre-operative clinic. After surgery, follow up of patient's progress will be carried out at 3 days in hospital; and at 1 month, 3 months, and 6 months and 1 year via telephone. The investigators expect the results of this observational study to influence further research into the use of frailty risk scoring prior to clinical decisions, and add to the evidence in assessing risk-related outcomes in cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Surgery | – | –Patients undergoing cardiac surgery: coronary artery bypass graft (CABG); valve replacement/repair; or transcatheter aortic valve implantation (TAVI) surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators are planning to recruit 120 adult patients undergoing elective coronary artery bypass graft (CABG); valve replacement/repair; or transcatheter aortic valve implantation (TAVI) surgery at King's College Hospital, Denmark Hill, London
Key inclusion criteria (4 listed)
- Aged 18 years or over
- Due to undergo elective cardiac surgery: coronary artery bypass graft (CABG); valve replacement/repair; or transcatheter aortic valve implantation (TAVI) surgery
- Able to give informed consent
- Fluency in English
Key exclusion criteria (5 listed)
- Emergency cardiac surgery and non-cardiac surgery
- Inadequate knowledge of English that will prevent patients from completing the consent or undertaking study assessments
- Severe visual, auditory, or motor handicap
- Concurrent diseases of the central nervous system,
- Patients at the extremes of frailty, in whom it would be unethical to perform a full assessment.
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
Disability-free survival
Time frame: 1 year
Defined as percentage of participants alive and with a disability score (using World Health Organisation Disability Assessment Schedule 2.0, WHODAS) of less than 25%.
5 secondary outcomes
Mortality
Time frame: 1 month postoperative
Delirium
Time frame: 3 days postoperative
In hospital complications
Time frame: 1 month
Return to theatre
Time frame: 1 month
Length of hospital stay
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
- Individual participant dataSharing planned: No. Contact research lead.
Related trials for Coronary Heart Disease
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
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.
Joshua Lucas de Carvalho principal investigator
King's College London
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease and Heart Valve Diseases, run by King's College Hospital NHS Trust.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Disability-free survival (time frame: 1 year). 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 22 Apr 2016.