Syncope
Conditions
Interventions
Product Name: Adenosine
Product Code: Adenosine
Pharmaceutical Form: Injection*
INN or Proposed INN: Adenosine
CAS Number: 58-61-7
Current Sponsor code: NA
Other descriptive name: NA
Concentration uni
Sponsors
Newcastle Hospitals Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Consecutive patients over 18 years with dual chamber permanent pacemakers implanted for SSS, AVB and CSS at Freeman Hospital during the first 8 months of the study, and if additional numbers are needed, over the last 5 years identified retrospectively, will be asked to participate, as will consecutive patients with tilt-diagnosed VVS. In addition: ·SSS and CSS patients must be in sinus rhythm (SR), or if suffering paroxysmal atrial fibrillation, in sinus rhythm (SR) for >50% of the time (from pacemaker diagnostics). ·AVB patients must have underlying SR with normal AV conduction for >90% of the time. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Inability to give informed consent, severe coronary disease (known coronary stenosis >70%, NYHA heart failure or angina symptoms Class III or IV), known severe cerebrovascular disease, myocardial infarction within 3 months, long corrected QT interval, uncorrected accessory pathway, history of asthma, COPD, pregnancy or lactation, dipyridamole or digoxin use, hypertrophic cardiomyopathy, cardiac transplantation, or known significant internal carotid artery stenosis (>50%). In addition: ·Patients with SSS: Persistent atrial fibrillation (AF); evidence of high degree AV block; complete AV block present for more than 10% of the time. If there is uncertainty regarding this, the lower rate of the device will be reduced and AV delay extended to assess underlying rhythm and AV conduction, with reassessment 1 month later. ·Patients with AVB: Evidence of sinus node disease as assessed by the amount of atrial pacing at pacemaker check. If uncertainty, the lower rate will be reduced and pacemaker rechecked at one month. ·Patients with CSS: Persistent AF or high degree AV block.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Adenosine administered intravenously slows heart rate, and over the last decade, the drug has been used in many centres in the diagnosis of unexplained syncope (blackouts). However, there is no clear consensus on which underlying disorder is being uncovered. Various researchers propose heart conducting tissue disease (sick sinus syndrome [SSS] and [AVB]) and neurally mediated syncope (carotid sinus syndrome [CSS] and vasovagal syncope [VVS - an exaggerated version of the common faint]) as the conditions diagnosed by adenosine. We propose the first ever study to tackle these issues comprehensively and systematically. The principal research objective will be to compare the heart rate response to adenosine with the underlying diagnosis in patients with SSS, AVB, CSS and VVS and healthy controls.;Secondary Objective: We also hope to define an abnormal response to adenosine (duration of heart block and/or asystole discriminating an abnormal response from a normal one) and further evaluate the tolerability of the procedure.;Primary end point(s): The primary outcome measures will be the sensitivity and specificity of the adenosine test in diagnosing SSS, AVB, CSS and VVS based on the current European Society of Cardiology guidelines, namely >6 seconds asystole or >10 seconds high degree AVB. | — |
Countries
United Kingdom
Outcome results
None listed