Status:
COMPLETED
Adenosine Testing to DEtermine the Need for Pacing Therapy
Lead Sponsor:
Newcastle-upon-Tyne Hospitals NHS Trust
Conditions:
Syncope
Eligibility:
All Genders
40+ years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 12 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2017
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01481168
Start Date
April 12 2012
End Date
January 26 2017
Last Update
November 20 2017
Active Locations (2)
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1
Royal Victoria Infirmary
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP
2
Feeeman Hospital
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN