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Trial record 12 of 42 for:    Syncope | Child

Eastbourne Syncope Assessment Study II (EaSyAS II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00517023
Recruitment Status : Unknown
Verified May 2008 by Eastbourne General Hospital.
Recruitment status was:  Recruiting
First Posted : August 16, 2007
Last Update Posted : May 9, 2008
Transoma Medical
East Sussex National Health Service Trust, United Kingdom
Information provided by:
Eastbourne General Hospital

Brief Summary:

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:

  1. To see how soon treatment is started once the abnormal rhythm is detected by the ILR.
  2. To see which group (patients with ILRs or those receiving conventional tests) receives treatment sooner.
  3. To see which group has less subsequent collapses i.e has benefited from appropriate treatment sooner.
  4. 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 or disease Intervention/treatment Phase
Syncope Device: Sleuth Implantable Loop Recorder Other: Other Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Eastbourne Syncope Assessment Study II
Study Start Date : August 2007
Estimated Primary Completion Date : July 2008
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Arm Intervention/treatment
Active Comparator: ILR + Syncope Clinic
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)

Active Comparator: ILR Only
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)

Active Comparator: Routine Mx + Syncope Clinic
Patients will receive routine care and management plus follow up in Syncope Clinic
Other: Other
Routine care and tests usually offered for syncope patients.

Active Comparator: Routine Mx
Patients will receive routine care and management
Other: Other
Routine care and tests usually offered for syncope patients.

Primary Outcome Measures :
  1. Primary Outcome 1. Time to ECG (objective) diagnosis of syncope [ Time Frame: 1 Year ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00517023

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Contact: A N Sulke, DM FRCP FESC FACC +44 1323 417400 ext 5869

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United Kingdom
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
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Principal Investigator: A N Sulke, DM FRCP FESC FACC Eastbourne General Hospital

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Responsible Party: Dr AN Sulke, Cardiac Department, Eastbourne General Hospital Identifier: NCT00517023     History of Changes
Other Study ID Numbers: 07/Q1907/13
First Posted: August 16, 2007    Key Record Dates
Last Update Posted: May 9, 2008
Last Verified: May 2008
Keywords provided by Eastbourne General Hospital:
Implantable Loop Recorder
Home monitoring
Syncope/ Falls Clinic
Additional relevant MeSH terms:
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Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms