Atrial Fibrillation After Surgery for Colorectal Cancer (AFAR)
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|ClinicalTrials.gov Identifier: NCT04037319|
Recruitment Status : Suspended (Study recruitment has been halted due to the Pandemic. It is anticipated that recruitment will restart in March 2021.)
First Posted : July 30, 2019
Last Update Posted : January 7, 2021
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.
|Condition or disease||Intervention/treatment|
|Colorectal Cancer Atrial Fibrillation New Onset||Diagnostic Test: 24 Hour Holter Monitor|
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 Type :||Observational|
|Estimated Enrollment :||720 participants|
|Official Title:||Atrial Fibrillation After Resection (AFAR): A PROGRESS III Study|
|Actual Study Start Date :||January 16, 2020|
|Estimated Primary Completion Date :||October 31, 2021|
|Estimated Study Completion Date :||February 28, 2022|
Will undergo surgery for colorectal cancer with curative intent as planned by local cancer multidisciplinary team.
Diagnostic Test: 24 Hour Holter Monitor
24 hour holter monitor to be performed pre-operatively, and at day 30 and 90 post-operatively.
- 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.
- Quality of life change (EQ-5D-5L (Euroqol-five dimension-five level) [ Time Frame: Within 90 days of colorectal cancer surgery ]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.
- Occurrence of complications of atrial fibrillation [ Time Frame: Within 90 days of colorectal cancer surgery ]Includes stroke and embolic events
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04037319
|Sheffield Teaching Hospitals NHS Foundation Trust|
|Sheffield, South Yorkshire, United Kingdom, S5 7AU|
|Principal Investigator:||Matthew Lee, MBChB PhD||Sheffield Teaching Hospitals NHS Foundation Trust|