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Adenosine Testing to DEtermine the Need for Pacing Therapy (ADEPT-ILR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01481168
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : November 20, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Syncope Device: Pacemaker implantation (Medtronic) Device: Implantable Loop Recorder (Medtronic) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adenosine Testing to DEtermine the Need for Pacing Therapy With the Additional Use of an Implantable Loop Recorder (ADEPT-ILR Study). The Efficacy of Permanent Pacing in Patients With Syncope and a Positive Intravenous Adenosine Test: a Randomised, Double-blind, Placebo-controlled, Cross-over Trial.
Actual Study Start Date : April 12, 2012
Actual Primary Completion Date : January 26, 2017
Actual Study Completion Date : January 26, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting
Drug Information available for: Adenosine

Arm Intervention/treatment
Active Comparator: Pacemaker "on"
DDD+/-R pacing
Device: Pacemaker implantation (Medtronic)
DDD+/-R pacing
Other Name: Medtronic DDD+/-R pacemakers

Placebo Comparator: Pacemaker "off"
ODO pacing
Device: Pacemaker implantation (Medtronic)
ODO pacing
Other Name: Medtronic DDR+/-R pacemakers.

Experimental: Implantable Loop Recorder
Implantable loop recorder in adenosine test negative patients
Device: Implantable Loop Recorder (Medtronic)
Loop recorder implantation
Other Name: Medtronic Reveal DX or XT

Primary Outcome Measures :
  1. Syncope Burden [ Time Frame: 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 :
  1. Time to first syncope [ Time Frame: 12 months ]
    Time to first syncope

  2. Number of patients with recurrent syncope [ Time Frame: 12 months ]
    Number of patients with >1 episodes of syncope

  3. Quality of life [ Time Frame: 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

  4. Health economic analysis [ Time Frame: 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.

  5. ECG diagnosis on ILR following syncopal episode in adenosine negative group [ Time Frame: 12 months ]
    ECG diagnosis on ILR following syncopal episode in intravenous adenosine test negative group

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01481168

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United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE1 4LP
Feeeman Hospital
Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
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Principal Investigator: Steve W Parry, PhD, MBBS, MRCP, BSc Institue of Ageing and Health, University of Newcastle
Principal Investigator: Chris J Pummer, PhD, MRCP, BMBCh, BSc Newcastle upon Tyne Hospitals NHS FOundation Trust
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Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust Identifier: NCT01481168    
Other Study ID Numbers: 5883
FS/11/13/28690 ( Other Grant/Funding Number: British Heart Foundation )
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases