Adenosine testing in the diagnosis of unexplained syncope: A pilot study - Adenosine testing in the diagnosis of unexplained syncope

Phase 1

• Conditions: Syncope

• Registration Number: EUCTR2004-002262-37-GB
• Lead Sponsor: ewcastle Hospitals Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-15
• Study Completion: 2005-10-31
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified