Advertisement

Topics

Prospective, Multi Centre, International Registry of Male and Female Patients Newly Diagnosed With Atrial Fibrillation

2014-08-27 03:15:05 | BioPortfolio

Summary

This protocol is a large global registry to determine the behaviour of patients with permanent atrial fibrillation (AF) in real-life practice. This will include newly diagnosed patients with permanent AF irrespective of whether or not they receive antiplatelet (anticoagulant or antithrombotic) therapy. In this regard the GARFIELD registry will be unique because it will consider treatment failure in both those who have commenced anticoagulant (Anticlotting) therapy or other pharmacological treatment to prevent stroke, and those who should have commenced anticoagulant therapy to prevent thromboembolic stroke in permanent AF.

Description

The registry will start with the 1st cohort starting in select main countries. There will be GARFIELD representatives on a country specific level during the first cohort. Then there will be a broader extension in subsequent cohorts. No single centre will be able to recruit sufficient number of patients to conduct the assessment and therefore it is proposed to identify a sufficient number of sites in community, hospital, or anticoagulation clinic settings throughout the world. The main focus of this registry is to capture the real-life anticoagulation treatment in the GP setting.

Data Registry: In the setting of clinical trials of stroke prevention in AF, regulatory authorities mandate a very tight control of anticoagulant therapy resulting in lower rates of therapeutic failure than usually seen in real-life clinical practice, making accurate assessment of the value of antithrombotic agents difficult.

Source Data: Data will be derived from the patients clinical records according to specifications outlined in the electronic case record form. This registry will not undertake any experimental intervention with patients being treated to normal local practice and with any coagulation investigations being performed as to normal routine. No additional tests or procedures are required by the protocol. Patient progress and events will be monitored for a minimum of 2 years from inclusion. Patients will be identified from multiple sources including the hospital (neurology, cardiology, geriatrics, internal medicine, and emergency room), anticoagulant clinic and general / family practice setting, and the identifying clinician will register the patient using the on-line electronic CRF. Thereafter, data on outcomes relevant to the registry will be collected from 4 clinical sources associated with the patient - hospital, emergency room, anticoagulation clinic and general / family practitioner, but these data will be collected on a four monthly basis through review of patient notes and clinical records.

Source data verification will be undertaken in five per cent of all cases. All data will be summarised or transcribed in the CRF from documents considered to be source data.

Validation Cohort will be added to the first cohort to register patients in select countries. 5000 patients with permanent AF enrolled will be enrolled.

The patients registered will be diagnosed with permanent atrial fibrillation, regardless of therapy, with a diagnosis history longer than six months prior to enrolment Data for patients in the validation cohort will be collected retrospectively from the time of diagnosis to entry in the registry, and prospectively for up to 2 years .

Allocation of Treatments This is a non-interventional, multi-centre, prospective registry and patients will be treated according to normal local practice.

Evaluations will be performed by the local clinical sites according to their routine. No change in routine practice will be required or encouraged in the registry.

Duration of Patient Participation It is anticipated that the total registry duration will be 6 years for all 5 cohorts allowing 4 years for recruitment and 2 years of follow up for each patient.

Discontinuation Criteria

1. Patients As this is a data registry there are no specific withdrawal criteria. However, the patient is free to withdraw consent at any time.

2. Entire Registry It is agreed that for reasonable cause either the Investigator or the sponsor, may terminate this registry before the expiration of the agreed time period, provided a written notice is submitted at a reasonable time in advance of intended termination.

Prospective Cohorts (Patient selection) It is proposed to identify a sufficient number of sites globally in hospital, community or anticoagulation clinic settings throughout the world to ensure representation in major countries with focus on the GP setting. 50,000 patients with newly diagnosed permanent AF with at least one additional risk factor for stroke will be enrolled in order to collect a representative sample. Patients will be enrolled as 5 independent cohorts of 10,000 patients each. An additional validation cohort of 5,000 patients with established permanent Atrial Fibrillation with at least one additional risk factor for stroke regardless of therapy and having been managed at sites for longer than 6 months will also be included in addition to the first prospective cohort of 10,000 patients.

All patients in each cohort will be identified and registered consecutively. For the validation cohort there will be in addition to the prospective follow-up, a retrospective data-collection for minimum of six months up to 2 years.

Study Design

N/A

Conditions

Permanent Atrial Fibrillation

Location

Penny Astridge
Cardiff
New South Wales
Australia
2285

Status

Recruiting

Source

Thrombosis Research Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:05-0400

Clinical Trials [806 Associated Clinical Trials listed on BioPortfolio]

CLINICAL INVESTIGATION OF THE LAMBRETM LEFT ATRIAL APPENDAGE CLOSURE SYSTEM

The aim of the study LA-EU-01 was to examine the safety and the feasibility of the LAmbreTM Left Atrial Appendage Closure System in patients with non-valvular paroxymal, persistent or perm...

Comparison of Effectiveness of Ranolazine Plus Metoprolol Combination vs. FlecainidE pluS Metoprolol Combination in ATrial Fibrillation Recurrences FOllowing PhaRmacological or Electrical CardioverSion of AtRial Fibrillation

Atrial fibrillation (AF) is the most common arrhythmia in clinical practice with a prevalence reaching 5% in patients older than 65 years and an incidence that increases progressively with...

D-dimer In Patients With atRial Fibrillation rEceiving antiCoagulation Therapy

This is a sigle-center, prospective study to evaluate the role of D-Dimer testing in patients with atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy.

Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery

The clinical effects of intra-operative radiofrequency ablation in patients with persistent or permanent atrial fibrillation and an indication for an implantation of a heart valve prosthes...

Heart Rate Regularization in Patients With Permanent Atrial Fibrillation Post Marketing Study

The purpose of this study is to monitor heart rate regularization in patients with permanent atrial fibrillation and standard indication for single chamber rate adaptive pacing VVI(R).

PubMed Articles [1567 Associated PubMed Articles listed on BioPortfolio]

Patients with atrial fibrillation and permanent pacemaker: Temporal changes in patient characteristics and pharmacotherapy.

The management of patients with non-valvular atrial fibrillation (NVAF) with rate-lowering or anti-arrhythmic drugs has markedly changed over the last decade, but it is unknown how these changes have ...

Atrial electrogram quality in single-pass defibrillator leads with floating atrial bipole in patients with permanent atrial fibrillation and cardiac resynchronization therapy.

Many patients receiving cardiac resynchronization therapy (CRT) suffer from permanent atrial fibrillation (AF). Knowledge of the atrial rhythm is important to direct pharmacological or interventional ...

Atrial fibrillation type matters: greater infarct volume and worse neurological defects seen in acute cardiogenic cerebral embolism due to persistent or permanent rather than paroxysmal atrial fibrillation.

Some studies have shown that the type of atrial fibrillation (AF), whether paroxysmal AF (PAF) or persistent or permanent AF (PeAF), affects the incidence of ischaemic stroke. This study sought to det...

Biomarkers determining prognosis of atrial fibrillation ablation.

Catheter ablation for rhythm control is recommended in specific patient populations with paroxysmal, persistent, or long-standing persistent atrial fibrillation. Pulmonary vein isolation is the corner...

Valsartan reduced the vulnerability to atrial fibrillation by preventing action potential prolongation and conduction slowing in castrated male mice.

Deficiency of testosterone was associated with the susceptibility of atrial fibrillation. Angiotensin-II receptor antagonists were shown to reduce atrial fibrillation by improving atrial electrical re...

Medical and Biotech [MESH] Definitions

Rapid, irregular atrial contractions caused by a block of electrical impulse conduction in the right atrium and a reentrant wave front traveling up the inter-atrial septum and down the right atrial free wall or vice versa. Unlike ATRIAL FIBRILLATION which is caused by abnormal impulse generation, typical atrial flutter is caused by abnormal impulse conduction. As in atrial fibrillation, patients with atrial flutter cannot effectively pump blood into the lower chambers of the heart (HEART VENTRICLES).

Long-term changes in the electrophysiological parameters and/or anatomical structures of the HEART ATRIA that result from prolonged changes in atrial rate, often associated with ATRIAL FIBRILLATION or long periods of intense EXERCISE.

A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone DIGOXIGENIN. Digoxin has positive inotropic and negative chronotropic activity. It is used to control ventricular rate in ATRIAL FIBRILLATION and in the management of congestive heart failure with atrial fibrillation. Its use in congestive heart failure and sinus rhythm is less certain. The margin between toxic and therapeutic doses is small. (From Martindale, The Extra Pharmacopoeia, 30th ed, p666)

A THROMBIN inhibitor which acts by binding and blocking thrombogenic activity and the prevention of thrombus formation. It is used to reduce the risk of stroke and systemic EMBOLISM in patients with nonvalvular atrial fibrillation.

A morpholine and thiophene derivative that functions as a FACTOR XA INHIBITOR and is used in the treatment and prevention of DEEP-VEIN THROMBOSIS and PULMONARY EMBOLISM. It is also used for the prevention of STROKE and systemic embolization in patients with non-valvular ATRIAL FIBRILLATION, and for the prevention of atherothrombotic events in patients after an ACUTE CORONARY SYNDROME.

More From BioPortfolio on "Prospective, Multi Centre, International Registry of Male and Female Patients Newly Diagnosed With Atrial Fibrillation"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...

Stroke - Cerebrovascular Disease (CVA)
A stroke is a serious medical condition that occurs when the blood supply to part of the brain is cut off. Strokes are a medical emergency and prompt treatment is essential because the sooner a person receives treatment for a stroke, the less damage is ...


Searches Linking to this Trial