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| Name | Class |
|---|---|
| Royal Brompton & Harefield NHS Foundation Trust | OTHER |
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Investigators will assess the impact of treatments for atrial fibrillation on participant's thrombotic status
AF affects 1 in 4 people in their lifetime. Although generally thought of as a safe heart rhythm disturbance, the risk associated with AF is through the formation of clot (thrombus) within the heart which be ejected from the heart when it contracts causing a heart attack or perhaps more devastatingly a stroke.
The mainstay of treatment for AF involves thinning the blood with drugs such as warfarin or newer drugs termed novel oral anticoagulants. In addition to this there are 3 main ways of treating the underlying rhythm disturbance:
The investigators study, through use of a relatively novel bedside test will examine the effects of each of these management strategies on the thrombotic status of the participant's blood.
Investigators will take blood from in total 500 participants divided between each of the above management strategies which has been decided by their parent teams (i.e. study does not affect their treatment).
Investigators will draw blood from the participants on up to 5 separate occasions over a 12 month period. In the group undergoing a DCCV, blood will be drawn shortly before and after the intervention and at 3 and 12 months post intervention. In the group undergoing an AF ablation blood will be drawn on 5 occasions - the day before the procedure, 1-2 days post, 3-4 days post, 3-4 months post and 12 months post. In the group treated with standard medical therapy, blood will be drawn at the time of enrolment in the study and at 3 and 12 months post enrolment.
It is the investigators hypothesis that permanent restoration of sinus rhythm through an atrial fibrillation ablation procedure will positively affect an individual participant's thrombotic status. There has been recent publication of registry data from the United States suggesting the long term rate of stroke in the population following an AF ablation approaches that of the population who have never suffered AF.
The investigators believe that the cause of the improvement in stroke rates following ablation is an improvement in thrombotic status which we hope to be test for the first time in a powered, prospective study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with AF | Split into 3: Those patients on treatment for AF involving blood thinning medicines (anticoagulants) +/- heart rate limiting drugs such as B blockers or digoxin. 100 patients in this group. Patients undergoing direct current cardioversion (DCCV) to temporarily restore normal (sinus) rhythm. 100 patients in this group. Patients undergoing an AF ablation to permanently restore sinus rhythm. 300 patients in this group. |
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| Measure | Description | Time Frame |
|---|---|---|
| Thrombotic status | This will be assessed using the investigator's novel bedside blood test. Each participant will have blood taken at predetermined points in time over a 12 month period. Some will have blood sampled on 3 different occasions, some on 4 occasions and the majority will have blood sampled on 5 occasions over the 12 months. The Global Thrombosis test provides information of the time taken for whole blood to clot (occlusion time) and then for the clot to naturally break down (lysis time) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse clinical event (MACE) | Over the time period that investigators are sampling, investigators will also note any major adverse clinical events such as heart attack, stroke or death. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Population of interest are adults (>18) diagnosed with atrial fibrillation (AF) who will be treated in one of 3 ways:
In total we aim to sample 500 patients divided into:
100 - Medical management 100 - Direct current cardioversion 300 - AF ablation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diana Gorog, MD PhD FRCP | Contact | 01707247512 | mary.odonnell@nhs.net | |
| Gareth Rosser, MBBS MRCP | Contact | g.rosser@rbht.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Diana Gorog, MD PhD FRCP | East and North Herts NHS Trust | Principal Investigator |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Whole blood Plasma store
| D013568 |
| Pathological Conditions, Signs and Symptoms |