Syncope | Eastbourne Syncope Assessment Study II
Syncope research study
What is the primary objective of this study?
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).
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:Sleuth Implantable Loop RecorderILR insertion under aseptic conditions in left pectoral region (local anaesthetic procedure only)
Other:OtherRoutine care and tests usually offered for syncope patients.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ILR + Syncope ClinicPatients will have ILR implanted and follow-up in Syncope Clinic
ILR OnlyPatients will have ILR implanted and routine follow up.
Routine Mx + Syncope ClinicPatients will receive routine care and management plus follow up in Syncope Clinic
Routine MxPatients will receive routine care and management
Start Date: August 2007
Completed Date: August 2009
Primary Outcome: Primary Outcome 1. Time to ECG (objective) diagnosis of syncope
Secondary Outcome: 1. Time to ECG directed therapy. 2. Time to introduction of empiric therapy. 3. Time to first post induction syncope. 4. Cost effectiveness analysis.
Study sponsors, principal investigator, and references
Principal Investigator: A N Sulke, DM FRCP FESC FACC
Lead Sponsor: Eastbourne General Hospital
Collaborator: Transoma Medical