Eastbourne Syncope Assessment Study II - Full Text View

Sponsors and Collaborators:	Eastbourne General Hospital Transoma Medical East Sussex National Health Service Trust, United Kingdom
Information provided by:	Eastbourne General Hospital
ClinicalTrials.gov Identifier:	NCT00517023

Purpose

Syncope (commonly called collapses or blackouts) is defined as loss of consciousness which is transient, self limiting and usually leads to falling.

While the causes of syncope encompass a wide variety of factors, those due to heart rhythm abnormalities are acknowledged to be significantly more serious compared with other causes.

The main aim of the study is to see if it is possible to find the cause of a patient's syncope faster using a device called an implantable loop recorder (ILR), which is implanted under the skin, versus conventional management. The device is slightly larger than a 50 pence coin and records the rhythm of the heart continuously.

Although ILRs are being used widely today, we want to use a new model that is able to relay information to the doctor via wireless technology and internet.

We also want to use ILRs earlier in diagnosing syncope, thereby avoiding unnecessary and lengthy hospital admissions and lowering cost.

Primary aim: To see how soon the ILR detects abnormal heart rhythms or normal ones (in study subjects who faint/ suffer syncope).

Secondary aims are:

To see how soon treatment is started once the abnormal rhythm is detected by the ILR.
To see which group (patients with ILRs or those receiving conventional tests) receives treatment sooner.
To see which group has less subsequent collapses i.e has benefited from appropriate treatment sooner.
To assess the cost effectiveness of using the implantable loop recorder more as a diagnostic tool for syncope versus conventional management (it should save many hospital admissions).

Condition	Intervention
Syncope	Device: Sleuth Implantable Loop Recorder Other: Other

MedlinePlus related topics: Fainting

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Factorial Assignment, Safety/Efficacy Study
Official Title:	Eastbourne Syncope Assessment Study II

Further study details as provided by Eastbourne General Hospital:

Primary Outcome Measures:

Primary Outcome 1. Time to ECG (objective) diagnosis of syncope [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

1. Time to ECG directed therapy. 2. Time to introduction of empiric therapy. 3. Time to first post induction syncope. 4. Cost effectiveness analysis. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ILR + Syncope Clinic: Active Comparator Patients will have ILR implanted and follow-up in Syncope Clinic	Device: Sleuth Implantable Loop Recorder ILR insertion under aseptic conditions in left pectoral region (local anaesthetic procedure only)
ILR Only: Active Comparator Patients will have ILR implanted and routine follow up.	Device: Sleuth Implantable Loop Recorder ILR insertion under aseptic conditions in left pectoral region (local anaesthetic procedure only)
Routine Mx + Syncope Clinic: Active Comparator Patients will receive routine care and management plus follow up in Syncope Clinic	Other: Other Routine care and tests usually offered for syncope patients.
Routine Mx: Active Comparator Patients will receive routine care and management	Other: Other Routine care and tests usually offered for syncope patients.

Detailed Description:

The original EaSyAS study (1998) evaluated the use of implantable loop recorders (ILRs) in the diagnosis and management of syncope.This demonstrated a significant increase in successful diagnosis following use of implantable loop recorders. Here there were 442 syncope admissions to Eastbourne in 2001. Diagnostic rate was 42%. In addition, time to diagnosis was quicker and therefore so was introduction of therapy. This resulted in significant increase in time to recurrent syncopal episodes and improved general wellbeing in an unselected population with syncope of an unknown cause.

The "Post-EaSyAS" study evaluated extended (2.5 years) follow up of these patients. The "Tis-EaSyAS" study evaluated 3 different tilt protocols with long term ILR follow up describing the positive predictive value of tilt testing in unexplained syncope.

The EaSyAS II study elaborates further the above by using the ILR to avoid hospital admission and optimise the use of a falls/syncope clinic, potentially improving cost effective diagnosis and management of syncope.

ILRs will be implanted without patient admission and with follow up in a syncope/falls assessment clinic, compared to optimal protocol driven current management.

The ILR used has capabilities to record and transmit heart rhythm abnormalities to a wireless receiver which will then relay the information to the clinician via the internet. It is hoped that this will shorten diagnosis times and speed up commencement of treatment for patients, and will avoid expensive tests and more expensive hospital admissions.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age > = 16 yrs
Acute syncope presentation to MAU or A+E
2 or more unexplained syncopes within the past 24 months including index episode
Normal baseline ECG
Absence of co - existing pathology requiring admission

Exclusion Criteria:

Suspected or known heart disease
ECG abnormalities suspected of arrhythmic syncope listed in Table 1
Syncope occurring during exercise
Syncope causing severe injury
Family history of sudden death
Sudden onset palpitations prior to syncope

Table 1: ECG Abnormalities:

Bifascicular block (defined as LBBB or RBBB combined with left anterior or left posterior fascicular block)
Other intraventricular abnormalities (QRS duration >= 0.12s)
Mobitz 1 second degree AV block (Wenckebach)
Asymptomatic sinus bradycardia (<50 bpm), SA node or sinus pause >= 3s in the absence of negatively chronotropic medications
Pre-excited QRS with short PR interval (WPW)
Significantly Prolonged QT interval
RBBB pattern with ST elevation in V1 - V3 (Brugada Syndrome)
Negative T waves with ST segment elevation in right precordial leads suggestive of arrythmogenic right ventricular dysplasia
Significant Q waves (>= 0.02s) suggestive of MI

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517023

Contacts

Contact: A N Sulke, DM FRCP FESC FACC

+44 1323 417400 ext 5869

neil.sulke@esht.nhs.uk

Locations

United Kingdom, East Sussex
Cardiology Department, Eastbourne General Hospital	Recruiting
Eastbourne, East Sussex, United Kingdom, BN21 2UD

Sponsors and Collaborators

Eastbourne General Hospital

Transoma Medical

East Sussex National Health Service Trust, United Kingdom

Investigators

Principal Investigator:

A N Sulke, DM FRCP FESC FACC

Eastbourne General Hospital

More Information

Responsible Party:	Cardiac Department, Eastbourne General Hospital ( Dr AN Sulke )
Study ID Numbers:	07/Q1907/13, T07-015
Study First Received:	August 15, 2007
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00517023
Health Authority:	United Kingdom: Research Ethics Committee; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Eastbourne General Hospital:

Implantable Loop Recorder
Home monitoring
Syncope/ Falls Clinic

Study placed in the following topic categories:

Signs and Symptoms
Unconsciousness
Consciousness Disorders

Neurologic Manifestations
Neurobehavioral Manifestations
Syncope

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009