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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
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Brief 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.

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

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.

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Study Type : Observational
Estimated Enrollment : 720 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Main cohort
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Occurrence of complications of atrial fibrillation [ Time Frame: Within 90 days of colorectal cancer surgery ]
    Includes stroke and embolic events

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Colorectal Cancer undergoing elective resection with curative intent.
Criteria

Inclusion Criteria:

  • Patients aged ≥65 years old
  • Undergoing elective surgery for colorectal cancer with curative intent
  • No prior diagnosis of atrial fibrillation.
  • Willing to consent

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom, S5 7AU
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Matthew Lee, MBChB PhD Sheffield Teaching Hospitals NHS Foundation Trust
Publications:
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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04037319    
Other Study ID Numbers: STH20223
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Atrial Fibrillation
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes