Assessment of Thrombotic Status in Patients With Atrial Fibrillation

NCT02583971 | Unknown

• 1 other identifier: No. 1.2 Oct 2015
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Investigators will assess the impact of treatments for atrial fibrillation on participant's thrombotic status

Conditions

Atrial Fibrillation

Keywords

Direct current cardioversion; Medical management; Atrial fibrillation ablation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Major adverse clinical event (MACE)

  12 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population of interest are adults (\>18) diagnosed with atrial fibrillation (AF) who will be treated in one of 3 ways: 1. Medical management 2. Direct current cardioversion 3. AF ablation In total we aim to sample 500 patients divided into: 100 - Medical management 100 - Direct current cardioversion 300 - AF ablation

You may qualify if:

• Male and female patients aged 18 years or over
• Patients diagnosed with atrial fibrillation managed in one of the 3 ways outlined above
• The patient is willing and able to understand the Patient Information Sheet and provide informed consent
• The patient must agree to comply with the drawing of blood samples for the assessments

You may not qualify if:

• Male and female patients aged \< 18 years of age
• The patient has, in the opinion of the investigator, significant neurological, hepatic, renal, endocrine, gastrointestinal, pulmonary, haemorrhagic, metabolic or other disease likely to confound the study requirements or analyses
• The patient has a history of substance abuse or demonstrates signs or clinical features of active substance abuse or psychiatric disease
• Alcohol consumption above recommended safe levels (i.e. more than 21 units per week for males, or more than 14 units per week for females) due to the potential effects of high alcohol levels on platelet reactivity
• Any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study
• Any major bleeding diathesis or blood dyscrasia (platelets \< 70 x 109/l, Hb \< 8 g/dl, INR \> 1.4, APTT \> x 2 UNL, leucocyte count \< 3.5 x 109/l, neutrophil count \< 1 x 109/l)
• Currently enrolled in an investigational device or drug trial

Sponsors & Collaborators

• East and North Hertfordshire NHS Trust: lead
• Royal Brompton & Harefield NHS Foundation Trust: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood Plasma store

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Diana Gorog, MD PhD FRCP

  East and North Herts NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Gorog, MD PhD FRCP

CONTACT

01707247512; mary.odonnell@nhs.net

Gareth Rosser, MBBS MRCP

CONTACT

g.rosser@rbht.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of cardiology

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: October 22, 2015
• Study Start: November 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2018
• Last Updated: August 3, 2016

Record last verified: 2016-08