Eastbourne Syncope Assessment Study II (EaSyAS II)

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).

Study Overview

• Status: Unknown
• Conditions: Syncope
• Intervention / Treatment: Device: Sleuth Implantable Loop Recorder; Other: Other

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.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: A N Sulke, DM FRCP FESC FACC; Phone Number: 5869 +44 1323 417400; Email: neil.sulke@esht.nhs.uk

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary Outcome 1. Time to ECG (objective) diagnosis of syncope	1 Year

Secondary Outcome Measures

Outcome Measure	Time Frame
1. Time to ECG directed therapy. 2. Time to introduction of empiric therapy. 3. Time to first post induction syncope. 4. Cost effectiveness analysis.	1 Year

Collaborators and Investigators

• Sponsor: Eastbourne General Hospital
• Collaborators: Transoma Medical; East Sussex National Health Service Trust, United Kingdom
• Investigators: Principal Investigator: A N Sulke, DM FRCP FESC FACC, Eastbourne General Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Anticipated): July 1, 2008
• Study Completion (Anticipated): August 1, 2009

Study Registration Dates

• First Submitted: August 15, 2007
• First Submitted That Met QC Criteria: August 15, 2007
• First Posted (Estimate): August 16, 2007

Study Record Updates

• Last Update Posted (Estimate): May 9, 2008
• Last Update Submitted That Met QC Criteria: May 6, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: Implantable Loop Recorder; Home monitoring; Syncope/ Falls Clinic
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Syncope
• Other Study ID Numbers: 07/Q1907/13; T07-015