Eastbourne Syncope Assessment Study II

Syncope Clinical Trial

— EaSyAS II  

Official title:

Eastbourne Syncope Assessment Study II

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00517023
• Other study ID #: 07/Q1907/13
• Secondary ID: T07-015
• Status: Recruiting
• Phase: N/A
• First received: August 15, 2007
• Last updated: May 6, 2008
• Start date: August 2007
• Est. completion date: August 2009

Study information

• Verified date: May 2008
• Source: Eastbourne General Hospital
• Contact: A N Sulke, DM FRCP FESC FACC
• Phone: +44 1323 417400
• Email: neil.sulke[@]esht.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Syncope

Intervention

Device:
• Sleuth Implantable Loop Recorder
ILR insertion under aseptic conditions in left pectoral region (local anaesthetic procedure only)

Other:
• Other
Routine care and tests usually offered for syncope patients.

Locations

Country	Name	City	State
United Kingdom	Cardiology Department, Eastbourne General Hospital	Eastbourne	East Sussex

Sponsors (3)

Lead Sponsor	Collaborator
Eastbourne General Hospital	East Sussex National Health Service Trust, United Kingdom, Transoma Medical

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome 1. Time to ECG (objective) diagnosis of syncope		1 Year	Yes
Secondary	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	No