Adenosine Testing to DEtermine the Need for Pacing Therapy

Not Applicable

Completed

• Conditions: Syncope

• Registration Number: NCT01481168
• Lead Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust

Brief Summary

The purpose of this study is to determine whether or not the intravenous adenosine test readily identifies patients with unexplained syncope who would benefit from permanent pacemaker implantation.

Detailed Description

The investigation of syncope (transient loss of consciousness with loss of postural tone, collapse and spontaneous recovery) varies widely, is often lengthy and frequently expensive. The intravenous adenosine test has been used in the investigation of syncope and is cheap, safe and free of serious side effects. However, it is unclear what diagnosis the test unearths. There is some evidence that the test readily identifies bradycardia pacing indications.

In this study we plan to perform the adenosine test and implant a pacemaker should the test be positive. In half of the patients we will turn the pacemaker "on" and in the other half the pacemaker "off". The groups will swap over after six months. During this time we will assess the number of syncopal episodes. Also, in those who have a negative adenosine test we will implant a loop recorder to try to discover the cause of syncope.

Study Timeline

• Study First Submitted: 2011-11-22
• Study First Submitted QC: 2011-11-28
• Study First Posted: 2011-11-29
• Study Start: 2012-04-12
• Primary Completion: 2017-01-26
• Study Completion: 2017-01-26
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-17
• Last Update Posted: 2017-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Episode of syncope
• Patient has provided written informed consent for participation in the study prior to any study specific procedures
• Male or female
• Age > 40 years
• No cause of syncope clearly identified on clinical examination, lying and standing blood pressure measurements and standard 12 lead ECG.

Exclusion Criteria

• Asthma or chronic obstructive pulmonary disease
• Severe coronary disease (myocardial infarction within 3 months, known coronary stenosis >70%, NYHA heart failure or angina symptoms Class III or IV)
• Known severe cerebrovascular disease or known significant internal carotid artery stenosis (>70%)
• Prolonged corrected QT interval
• Unablated accessory pathway
• Pregnancy or lactation
• Use of dipyridamole or any rate-limiting medication that cannot be safely discontinued
• Hypertrophic cardiomyopathy
• Cardiac transplantation
• Concurrent participation in another investigational study or trial
• Inability to give informed consent; carer/proxy assent will be allowed in this study
• Cause of syncope established from initial clinical history and examination, lying and standing blood pressure and ECG

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Syncope Burden	12 months	Syncope Burden as measured by number of syncopal episodes and recorded by weekly postal patient diaries with telephone reminders to ensure adequate return

Secondary Outcome Measures

Name	Time	Method
Time to first syncope	12 months	Time to first syncope
ECG diagnosis on ILR following syncopal episode in adenosine negative group	12 months	ECG diagnosis on ILR following syncopal episode in intravenous adenosine test negative group
Quality of life	12 months	Quality of life as measured via the condition-specific instrument the Impact of Syncope on Quality of Life questionnaire with general health-related quality of life measured via the WHOQoL-Brief and WHOQoL-Old instruments
Health economic analysis	12 months	Costs and benefits of the intervention to health and social services. (i) Use of EQ-5D questionnaire to establish the cost per Quality Adjusted Life Year (QALY) (ii) The analysis will include the patients described above as well as a historical comparator group of consecutive patients derived from the database held by the Falls and Syncope Service who have not undergone adenosine testing. This group is particularly important to establish the utility of adenosine testing in the diagnosis of unexplained syncope.
Number of patients with recurrent syncope	12 months	Number of patients with \>1 episodes of syncope

Trial Locations

Locations (2)

Royal Victoria Infirmary; 🇬🇧 Newcastle upon Tyne, Tyne And Wear, United Kingdom

Feeeman Hospital; 🇬🇧 Newcastle upon Tyne, Tyne And Wear, United Kingdom