Eastbourne Syncope Assessment Study II

NCT00517023 | Unknown

• 2 other identifiers: 07/Q1907/13T07-015
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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. 1.To see how soon treatment is started once the abnormal rhythm is detected by the ILR.
2. 2.To see which group (patients with ILRs or those receiving conventional tests) receives treatment sooner.
3. 3.To see which group has less subsequent collapses i.e has benefited from appropriate treatment sooner.
4. 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).

Conditions

Syncope

Keywords

Implantable Loop Recorder; Home monitoring; Syncope/ Falls Clinic

Outcome Measures

Primary Outcomes (1)

• Primary Outcome 1. Time to ECG (objective) diagnosis of syncope

  1 Year

Secondary Outcomes (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.

  1 Year

Study Arms (4)

ILR + Syncope Clinic

ACTIVE COMPARATOR

Patients will have ILR implanted and follow-up in Syncope Clinic

Device: Sleuth Implantable Loop Recorder

ILR Only

ACTIVE COMPARATOR

Patients will have ILR implanted and routine follow up.

Device: Sleuth Implantable Loop Recorder

Routine Mx + Syncope Clinic

ACTIVE COMPARATOR

Patients will receive routine care and management plus follow up in Syncope Clinic

Other: Other

Routine Mx

ACTIVE COMPARATOR

Patients will receive routine care and management

Other: Other

Interventions

Sleuth Implantable Loop Recorder DEVICE

ILR insertion under aseptic conditions in left pectoral region (local anaesthetic procedure only)

ILR + Syncope Clinic; ILR Only

Other OTHER

Routine care and tests usually offered for syncope patients.

Routine Mx; Routine Mx + Syncope Clinic

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastbourne General Hospital: lead
• Transoma Medical: collaborator
• East Sussex National Health Service Trust, United Kingdom: collaborator

Study Sites (1)

Cardiology Department, Eastbourne General Hospital

Eastbourne, East Sussex, BN21 2UD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Syncope

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• A N Sulke, DM FRCP FESC FACC

  Eastbourne General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

A N Sulke, DM FRCP FESC FACC

CONTACT

+44 1323 417400; neil.sulke@esht.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 15, 2007
• First Posted: August 16, 2007
• Study Start: August 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: August 1, 2009
• Last Updated: May 9, 2008

Record last verified: 2008-05

Locations

GB (1)