Syncope | Adenosine Testing to DEtermine the Need for Pacing Therapy
Syncope research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
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:Pacemaker implantation (Medtronic)DDD+/-R pacing
Device:Pacemaker implantation (Medtronic)ODO pacing
Device:Implantable Loop Recorder (Medtronic)Loop recorder implantation
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.
Pacemaker "on"DDD+/-R pacing
Pacemaker "off"ODO pacing
Implantable Loop RecorderImplantable loop recorder in adenosine test negative patients
Start Date: April 12, 2012
Completed Date: January 26, 2017
Primary Outcome: Syncope Burden
Secondary Outcome: Time to first syncope
Study sponsors, principal investigator, and references
Principal Investigator: Steve W Parry, PhD, MBBS, MRCP, BSc
Lead Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust