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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Newcastle-upon-Tyne Hospitals NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Steve Parry, Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01481168
First received: November 22, 2011
Last updated: February 22, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Syncope
Device: Pacemaker implantation (Medtronic)
Device: Implantable Loop Recorder (Medtronic)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Newcastle-upon-Tyne Hospitals NHS Trust:

Primary Outcome Measures:
  • Syncope Burden [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Time to first syncope [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Time to first syncope

  • Number of patients with recurrent syncope [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of patients with >1 episodes of syncope

  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Costs and benefits of the intervention to health and social services. (i) Use of EQ-5D questionnaire to establish the cost per Quality Adujusted 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.

  • ECG diagnosis on ILR following syncopal episode in adenosine negative group [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    ECG diagnosis on ILR following syncopal episode in intravenous adenosine test negative group


Estimated Enrollment: 180
Study Start Date: January 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 pacemkaers.
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481168

Contacts
Contact: Steve W Parry, PhD, MRCP, MBBS, BSc 44 191 282 5893 steve.parry@nuth.nhs.uk
Contact: Iain G Matthews, MRCP, MBChB 44 191 2821826 iain.matthews@nuth.nhs.uk

Locations
United Kingdom
Royal Victoria Infirmary Recruiting
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP
Contact: Steve W Parry, PhD, MRCP, MBBS, BSc    44 191 282 5893    steve.parry@nuth.nhs.uk   
Contact: Iain G Matthews, MRCP, MBChB    44 191 288 1826    iain.matthews@nuth.nhs.uk   
Principal Investigator: Steve W Parry, PhD, MRCP, MBBS, BSc         
Sub-Investigator: Iain G Matthews, MRCP, MBChB         
Feeeman Hospital Active, not recruiting
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Investigators
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
  More Information

No publications provided

Responsible Party: Dr. Steve Parry, Senior Lecturer and Honorary Consultant Physician, Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01481168     History of Changes
Other Study ID Numbers: 5883, FS/11/13/28690
Study First Received: November 22, 2011
Last Updated: February 22, 2012
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Syncope
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on April 16, 2014