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Trial record 62 of 1198 for:    adenosine

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

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ClinicalTrials.gov Identifier: NCT01481168
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust

Tracking Information
First Submitted Date  ICMJE November 22, 2011
First Posted Date  ICMJE November 29, 2011
Last Update Posted Date November 20, 2017
Actual Study Start Date  ICMJE April 12, 2012
Actual Primary Completion Date January 26, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01481168 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
  • Time to first syncope [ Time Frame: 12 months ]
    Time to first syncope
  • Number of patients with recurrent syncope [ Time Frame: 12 months ]
    Number of patients with >1 episodes of syncope
  • 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
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2011)
  • Time to first syncope [ Time Frame: 12 months ]
    Time to first syncope
  • Number of patients with recurrent syncope [ Time Frame: 12 months ]
    Number of patients with >1 episodes of syncope
  • 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
  • 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 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 ]
    ECG diagnosis on ILR following syncopal episode in intravenous adenosine test negative group
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adenosine Testing to DEtermine the Need for Pacing Therapy
Official Title  ICMJE 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Syncope
Intervention  ICMJE
  • Device: Pacemaker implantation (Medtronic)
    DDD+/-R pacing
    Other Name: Medtronic DDD+/-R pacemakers
  • Device: Pacemaker implantation (Medtronic)
    ODO pacing
    Other Name: Medtronic DDR+/-R pacemakers.
  • Device: Implantable Loop Recorder (Medtronic)
    Loop recorder implantation
    Other Name: Medtronic Reveal DX or XT
Study Arms  ICMJE
  • Active Comparator: Pacemaker "on"
    DDD+/-R pacing
    Intervention: Device: Pacemaker implantation (Medtronic)
  • Placebo Comparator: Pacemaker "off"
    ODO pacing
    Intervention: Device: Pacemaker implantation (Medtronic)
  • Experimental: Implantable Loop Recorder
    Implantable loop recorder in adenosine test negative patients
    Intervention: Device: Implantable Loop Recorder (Medtronic)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2017)
52
Original Estimated Enrollment  ICMJE
 (submitted: November 28, 2011)
180
Actual Study Completion Date  ICMJE January 26, 2017
Actual Primary Completion Date January 26, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01481168
Other Study ID Numbers  ICMJE 5883
FS/11/13/28690 ( Other Grant/Funding Number: British Heart Foundation )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Newcastle-upon-Tyne Hospitals NHS Trust
Study Sponsor  ICMJE Newcastle-upon-Tyne Hospitals NHS Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Newcastle-upon-Tyne Hospitals NHS Trust
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP