Colorectal CancerAFARNCT04037319
Atrial Fibrillation After Surgery for Colorectal Cancer
An observational study of Colorectal Cancer and Atrial Fibrillation New Onset, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study will report the incidence of atrial fibrillation after elective colorectal cancer resection in the over 65 age group. This will be used to validate a risk model for the development of post-operative atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Atrial Fibrillation New Onset
- What is being tested?
- 24 Hour Holter Monitor
- How many people
- 720 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jan 2020to 31 Mar 2024
- 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: Patients with Colorectal Cancer undergoing elective resection with curative intent.
Who may be able to join
- Patients aged ≥65 years old
- Undergoing elective surgery for colorectal cancer with curative intent
- No prior diagnosis of atrial fibrillation.
- Willing to consent
Who cannot join
- Patients aged less than 65 years old
- Pre-existing atrial fibrillation (persistent or paroxysmal)
- Unable to provide informed consent
- Life expectancy <12 months
- Prisoners
- Known pregnancy
- Lack mental capacity
- Patients with limited English language as there is no funding to cover costs of translation of materials
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S5 7AU
Debby Hawkins, PhD, +44 0114 2434343, debby.hawkins@nhs.net
Matthew J Lee, MBChB PhD
About this study
Official title: Atrial Fibrillation After Resection (AFAR): A PROGRESS III Study
This study will report the incidence of atrial fibrillation after elective colorectal cancer resection in the over 65 age group. This will be used to validate a risk model for the development of post-operative atrial fibrillation.
Eligible patients will undergo electrocardiogram based screening for atrial fibrillation, as well as brain natriuretic peptide tests prior to surgery. They will undergo 24 hour holter monitor prior to surgery, and at 30 and 90 days following surgery.
The primary outcome will be occurrence of atrial fibrillation within 90 days of surgery. Secondary outcomes include quality of life change, use of hospital services for atrial fibrillation, and complications of atrial fibrillation. This will be used to validate the pre-existing model for prediction of atrial fibrillation.
Read the detailed description
Background Atrial fibrillation is an irregularly irregular heartbeat and occurs in around 1.5% of the population. It is associated with negative clinical outcomes such as cardiac failure and mortality. It is strongly implicated in the evolution of stroke, which carries significant burden and cost to patients and the National Health Service (NHS). Atrial fibrillation can be triggered by major physiological stresses such as surgery. The literature suggests that symptomatic atrial fibrillation occurs in 10% of patients within 90 days of surgery. This means that a proportion of patients may have undetected atrial fibrillation, and require treatment to reduce their risk of complications. As the investigators move towards stratified and personalised medicine, it is important to identify the characteristics of the patients at risk of developing atrial fibrillation after surgery in order to mitigate the effects of the condition. This research group has proposed a basic model to stratify patients into high risk groups for post-operative atrial fibrillation, although this requires testing and refinement in a prospective study.
Aims To estimate the rate of atrial fibrillation following colorectal cancer surgery and to characterise patients at highest risk of atrial fibrillation following surgery for colorectal cancer.
Method A prospective study of patients over the age of 65 undergoing colorectal cancer resection will be conducted across 15 colorectal units in the United Kingdom. It will recruit 720 patients over an 18 month period. The study has been designed with regard to public and patient involvement. Patients over the age of 65 undergoing surgery for colorectal cancer with curative intent and no prior diagnosis of atrial fibrillation will be eligible for inclusion. Participants will be screened prior to entry with an electrocardiogram (ECG). Following consent, routine demographic data, EQ-5D-5L (five dimension), and blood sample for Brain Natriuretic Peptide (BNP) will be collected. A 24-hour cardiac rhythm recording will be undertaken prior to surgery to confirm the absences of atrial fibrillation. ECG will be repeated on the day of discharge and 24 hour rhythm recordings repeated at 30 and 90 days post surgery. EQ-5D-5L x will be recorded at 90 days along with any use of health services for cardiac symptoms. Participants diagnosed with atrial fibrillation during the study will be directed to local inpatient or primary care services as appropriate. Demographic characteristics, ECG parameters and BNP will be combined with a previously derived model and tested for ability to predict atrial fibrillation.
- Conditions
- Colorectal Cancer, Atrial Fibrillation New Onset
- Being tested
- 24 Hour Holter Monitor
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24 Hour Holter MonitorDiagnostic test
24 hour holter monitor to be performed pre-operatively, and at day 30 and 90 post-operatively.
| Study group | Role | What they receive |
|---|---|---|
| Main cohort | Will undergo surgery for colorectal cancer with curative intent as planned by local cancer multidisciplinary team. Receives: Diagnostic Test: 24 Hour Holter Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of atrial fibrillation within 90 days of colorectal cancer surgery, defined as ≥30 seconds of atrial fibrillation identified on a 24-hour cardiac monitor OR absence of p waves and irregularly irregular rhythm on an electrocardiogram
24-hour recordings will be undertaken at 30 \& 90 days post surgery, and electrocardiogram on the day of discharge from hospital.
Measured: Within 90 days of colorectal cancer surgery
Secondary outcomes (3)
Quality of life change (EQ-5D-5L (Euroqol-five dimension-five level)
Quality of life change as measured using EQ-5D-5L from baseline to 90 days post-surgery calculated as population adjusted health index based on total score. In the UK population this can range from -0.594 to 1.0. Higher values are associated with better quality of life scores. A positive change in quality of life index means improved quality of life.
Measured: Within 90 days of colorectal cancer surgery
Occurrence of complications of atrial fibrillation
Includes stroke and embolic events
Measured: Within 90 days of colorectal cancer surgery
Number of events of use of health services for atrial fibrillation or sequelae of atrial fibrillation
Number of events where health services accessed (e.g. primary care, hospital) including for treatment of atrial fibrillation or consequences such as cardiac failure, thromboembolism, or stroke.
Measured: Within 90 days of colorectal cancer surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start16 Jan 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Lee, MBChB PhD, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037319
- Sponsor's protocol ID
- STH20223
- Acronym
- AFAR
- Status last verified
- Jan 2021
- First submitted
- 26 Jun 2019
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Heywood EG, Drake TM, Bradburn M, Lee J, Wilson MJ, Lee MJ. Atrial Fibrillation After Gastrointestinal Surgery: Incidence and Associated Risk Factors. J Surg Res. 2019 Jun;238:23-28. doi: 10.1016/j.jss.2019.01.017. Epub 2019 Feb 5.
PubMed 30735962Chebbout R, Heywood EG, Drake TM, Wild JRL, Lee J, Wilson M, Lee MJ. A systematic review of the incidence of and risk factors for postoperative atrial fibrillation following general surgery. Anaesthesia. 2018 Apr;73(4):490-498. doi: 10.1111/anae.14118. Epub 2017 Nov 4.
PubMed 29105078
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation After Resection (AFAR): A PROGRESS III Study
- ClinicalTrials.gov ID
- NCT04037319
- Acronym / sponsor ID
- AFAR / STH20223
- Conditions
- Colorectal Cancer, Atrial Fibrillation New Onset
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 30 Jul 2019 (actual)
- 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 report the incidence of atrial fibrillation after elective colorectal cancer resection in the over 65 age group. This will be used to validate a risk model for the development of post-operative atrial fibrillation.
Eligible patients will undergo electrocardiogram based screening for atrial fibrillation, as well as brain natriuretic peptide tests prior to surgery. They will undergo 24 hour holter monitor prior to surgery, and at 30 and 90 days following surgery.
The primary outcome will be occurrence of atrial fibrillation within 90 days of surgery. Secondary outcomes include quality of life change, use of hospital services for atrial fibrillation, and complications of atrial fibrillation. This will be used to validate the pre-existing model for prediction of atrial fibrillation.
Detailed description
Background Atrial fibrillation is an irregularly irregular heartbeat and occurs in around 1.5% of the population. It is associated with negative clinical outcomes such as cardiac failure and mortality. It is strongly implicated in the evolution of stroke, which carries significant burden and cost to patients and the National Health Service (NHS). Atrial fibrillation can be triggered by major physiological stresses such as surgery. The literature suggests that symptomatic atrial fibrillation occurs in 10% of patients within 90 days of surgery. This means that a proportion of patients may have undetected atrial fibrillation, and require treatment to reduce their risk of complications. As the investigators move towards stratified and personalised medicine, it is important to identify the characteristics of the patients at risk of developing atrial fibrillation after surgery in order to mitigate the effects of the condition. This research group has proposed a basic model to stratify patients into high risk groups for post-operative atrial fibrillation, although this requires testing and refinement in a prospective study.
Aims To estimate the rate of atrial fibrillation following colorectal cancer surgery and to characterise patients at highest risk of atrial fibrillation following surgery for colorectal cancer.
Method A prospective study of patients over the age of 65 undergoing colorectal cancer resection will be conducted across 15 colorectal units in the United Kingdom. It will recruit 720 patients over an 18 month period. The study has been designed with regard to public and patient involvement. Patients over the age of 65 undergoing surgery for colorectal cancer with curative intent and no prior diagnosis of atrial fibrillation will be eligible for inclusion. Participants will be screened prior to entry with an electrocardiogram (ECG). Following consent, routine demographic data, EQ-5D-5L (five dimension), and blood sample for Brain Natriuretic Peptide (BNP) will be collected. A 24-hour cardiac rhythm recording will be undertaken prior to surgery to confirm the absences of atrial fibrillation. ECG will be repeated on the day of discharge and 24 hour rhythm recordings repeated at 30 and 90 days post surgery. EQ-5D-5L x will be recorded at 90 days along with any use of health services for cardiac symptoms. Participants diagnosed with atrial fibrillation during the study will be directed to local inpatient or primary care services as appropriate. Demographic characteristics, ECG parameters and BNP will be combined with a previously derived model and tested for ability to predict atrial fibrillation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main cohort | – | Diagnostic Test: 24 Hour Holter MonitorWill undergo surgery for colorectal cancer with curative intent as planned by local cancer multidisciplinary team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Colorectal Cancer undergoing elective resection with curative intent.
Key inclusion criteria (4 listed)
- Patients aged ≥65 years old
- Undergoing elective surgery for colorectal cancer with curative intent
- No prior diagnosis of atrial fibrillation.
- Willing to consent
Key exclusion criteria (8 listed)
- Patients aged less than 65 years old
- Pre-existing atrial fibrillation (persistent or paroxysmal)
- Unable to provide informed consent
- Life expectancy <12 months
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24 Hour Holter Monitor24 hour holter monitor to be performed pre-operatively, and at day 30 and 90 post-operatively. | Diagnostic test | Main cohort |
Primary outcome
Incidence of atrial fibrillation within 90 days of colorectal cancer surgery, defined as ≥30 seconds of atrial fibrillation identified on a 24-hour cardiac monitor OR absence of p waves and irregularly irregular rhythm on an electrocardiogram
Time frame: Within 90 days of colorectal cancer surgery
24-hour recordings will be undertaken at 30 \& 90 days post surgery, and electrocardiogram on the day of discharge from hospital.
3 secondary outcomes
Quality of life change (EQ-5D-5L (Euroqol-five dimension-five level)
Time frame: Within 90 days of colorectal cancer surgery
Occurrence of complications of atrial fibrillation
Time frame: Within 90 days of colorectal cancer surgery
Number of events of use of health services for atrial fibrillation or sequelae of atrial fibrillation
Time frame: Within 90 days of colorectal cancer surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Background: PubMed 30735962Heywood EG, Drake TM, Bradburn M, Lee J, Wilson MJ, Lee MJ. Atrial Fibrillation After Gastrointestinal Surgery: Incidence and Associated Risk Factors. J Surg Res. 2019 Jun;238:23-28. doi: 10.1016/j.jss.2019.01.017. Epub 2019 Feb 5.
- Background: PubMed 29105078Chebbout R, Heywood EG, Drake TM, Wild JRL, Lee J, Wilson M, Lee MJ. A systematic review of the incidence of and risk factors for postoperative atrial fibrillation following general surgery. Anaesthesia. 2018 Apr;73(4):490-498. doi: 10.1111/anae.14118. Epub 2017 Nov 4.
- Individual participant dataSharing planned: Undecided
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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.
Matthew Lee, MBChB PhD principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
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 Colorectal Cancer and Atrial Fibrillation New Onset, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 8 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 8 Oct 2021. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Debby Hawkins, PhD (+(0)114 243 43 43, debby.hawkins@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of atrial fibrillation within 90 days of colorectal cancer surgery, defined as ≥30 seconds of atrial fibrillation identified on a 24-hour cardiac monitor OR absence of p waves and irregularly irregular rhythm on an electrocardiogram (time frame: Within 90 days of colorectal cancer surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04037319, which also lists 2 linked publications.
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 8 Oct 2021.