Respiratory Tract (Lung and Bronchial) Diseases

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All Conditions

Nervous System Diseases

Heart and Blood Diseases

Immune System Diseases

Behaviors and Mental Disorders

Apnea

Sleep Apnea Syndromes

Sleep Apnea, Obstructive

Necrosis

Atrial Fibrillation

Arrhythmias, Cardiac

Hypersensitivity

Syndrome

Heart Diseases

Respiration Disorders

Respiratory Tract Diseases

Signs and Symptoms, Respiratory

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

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Natriuretic Agents

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Natriuretic Peptide, Brain

Participants who will receive the Implantable Loop Recorder (Reveal-LINQ) inserted just after baseline. This is single intervention and lasts for 3 years after which the patient has the option to have it removed.

Participants who will not get the Implantable Loop Recorder (Reveal-LINQ).

Insertion of monitoring device called Reveal-LINQ (an implantable loop recorder)

Reveal LINQ

This study is a prevelance trial looking at how sleep apnoea affects the heart especially heart rhythms.

Previous research shows that patients suffering from sleep apnoea are much more likely to get heart disease and abnormal heart rhythms (arrhythmias). These defects are sometimes missed by the traditional methods of monitoring i.e. 24-hour Holter monitor and ECGs. This means potentially dangerous arrhythmias may not be detected. Additionally, standard therapy for sleep apnoea does not significantly reduce the risk of heart disease.

This study will recruit 200 participants over a period of 18 months. The research team will observe the heart rhythms of sleep apnoea patients by inserting an implantable loop recorder (ILR) in up to 100 participants. The other 100 patients will simply have standard care. This device will monitor the heart continuously for 3 years allowing us to detect abnormal heart rhythms and treat as necessary.

Demonstrating the incidence of arrhythmia can lead onto a larger study which may change future sleep apnoea management improving their cardiovascular outcomes. Other markers of heart disease such as; blood tests, Magnetocardiography and Echocardiography will be performed on participants to shed more light on the mechanisms which link sleep apnoea and heart disease/arrhythmia.

Sleep apnoea affects up to 1.5 million adults in the United Kingdom (UK). This puts this population at risk of reduced oxygen levels during sleep, poor sleep and increased breathing effort . All of the above put stress on the body and are proven to increase the risk of high blood pressure, heart failure and vascular problems. This can lead to strokes, heart disease and death.

Sleep apnoea patients are at much higher risk of abnormal heart rhythms. Even with continuous positive airways pressure (CPAP) treatment (which is the mainstay in sleep apnoea and does help to reduce arrhythmias) patients are still at higher risk of heart disease and stroke.

An implantable loop recorder (Reveal-LINQ) inserted into sleep apnoea patients will be able to continuously monitor a patient's heart rhythm. This will determine the incidence of arrhythmia in sleep apnoea patients. Any significant abnormalities in either arm of the study will be treated as per National Health Service guidelines and best care. The cost associated with this method of intervention will also be considered.

If there is a high prevalence of arrhythmia a future larger trial, involving much larger numbers and multiple centres, could be conducted to demonstrate reduced risk of stroke or heart attack using this method of arrhythmia detection and management.

Cardiovascular biomarkers, cardiac function, autonomic function and magnetocardiography in these patients could shed light on the mechanisms which cause increased cardiovascular morbidity and mortality.

2 groups with the intervention the difference.

Obstructive Sleep Apnoea and Cardiac Arrhythmias

Obstructive Sleep Apnoea and Cardiac Arrhythmias and the Impact of an Implantable Loop Recorder

Incidence of arrhythmia in sleep apnoea patients as recorded by ILR vs a no ILR group

Assess the changes to the heart in sleep apnoea patients before and after CPAP in terms of heart rate variability as measured on 24 hour holter monitors. The raw data is taken from the monitor and then analysed manually. The first data set will be from baseline studies which will be compared to studies done at the 1 year follow-up.

Explore the onset and frequency of atrial fibrillation in sleep apnoea patients in order to determine what method of detection is efficient and cost effective.

Explore the impact of inserting an ILR in patients with sleep apnoea on cardiovascular morbidity (stroke and myocardial infarction) compared to those without ILR

Explore the impact of inserting an ILR in patients with sleep apnoea on cardiovascular mortality (stroke and/or myocardial infarction resulting in death) compared to those without ILR

Explore the changes to the heart in sleep apnoea patients before and after CPAP in terms of vascular biomarkers - high sensitivity C-Reactive Protein, high sensitivity Troponin-T, N-terminal pro B-type Natriuretic Peptide, Tumour Necrosis Factor-alpha, Matrix Metalloproteinase-9, Interleukin-6, Fibroblast Growth Factor-23. The first data set will be from baseline studies which will be compared to studies done at the 1 year follow-up.

Explore the changes to the heart in sleep apnoea patients before and after CPAP in terms of echocardiogram measures.

Quality of life measures before and after CPAP as measured by the EQ-5D 5 level questionnaire. This measures various quality of life points from a scale of 1-5. 1 represents poor quality of life and 5 represents good quality of life for each factor. This data will be analysed as per the EuroQol algorithm. The first data set will be from baseline studies which will be compared to studies done at the 1 year follow-up.

University Hospitals Coventry and Warwickshire NHS Trust

Neoplasms

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Will undergo surgery for colorectal cancer with curative intent as planned by local cancer multidisciplinary team.

24 hour holter monitor to be performed pre-operatively, and at day 30 and 90 post-operatively.

24 Hour Holter Monitor

Debby Hawkins, PhD

Matthew J Lee, MBChB PhD

Steven R Brown, MD

Matthew Lee, MBChB PhD

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.

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.

Atrial Fibrillation After Surgery for Colorectal Cancer

Atrial Fibrillation After Resection (AFAR): A PROGRESS III Study

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 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.

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.

Sheffield Teaching Hospitals NHS Foundation Trust

Skin and Connective Tissue Diseases

Substance Related Disorders

Wounds and Injuries

Lung Neoplasms

Breast Neoplasms

Cardiotoxicity

All patients undergoing RT for Thoracic Malignancies

All patients undergoing RT for Breast Cancer

Cafer Zorkun, MD PhD

Radiotherapy associated Atrial Fibrillation (RADAF) is an observational study to evaluate onset time and frequency of atrial fibrillation in patients with thoracic malignancies and breast cancer.

Each patient will have 12 lead ECG prior, and daily during radiotherapy.

Collected data will be truly anonymised and individuals will no longer identifiable, and than evaluated for occurrence of atrial fibrillation.

Inclusing Criteria:

1. Patients with radiotherapy for thoracic malignancy or breast cancer
2. Between 18-99 years-old

Exclusion Criteria:

1. Patients with history of radiotherapy
2. Patients with history of atrial fibrillation
3. Patients with pacemaker implantation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Obstructive Sleep Apnoea and Cardiac Arrhythmias	NCT03866148	Obstructive Sle... Cardiovascular ... Arrhythmia Atrial Fibrilla...	Reveal LINQ	18 Years - 75 Years	University Hospitals Coventry and Warwickshire NHS Trust
Atrial Fibrillation After Surgery for Colorectal Cancer	NCT04037319	Colorectal Canc... Atrial Fibrilla...	24 Hour Holter ...	18 Years -	Sheffield Teaching Hospitals NHS Foundation Trust
Radiotherapy-Associated Atrial Fibrillation	NCT05927246	Atrial Fibrilla...	ECG	18 Years - 99 Years	Istanbul University

Spots Global Cancer Trial Database for atrial fibrillation new onset