SyncopeADEPT-ILRNCT01481168
Adenosine Testing to DEtermine the Need for Pacing Therapy
A study testing Pacemaker implantation (Medtronic) and Implantable Loop Recorder (Medtronic) in people with Syncope, run by Newcastle-upon-Tyne Hospitals NHS Trust at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Syncope
- What is being tested?
- Pacemaker implantation (Medtronic) and Implantable Loop Recorder (Medtronic)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 12 Apr 2012to 26 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Victoria Infirmary
Newcastle upon Tyne, Tyne and Wear, NE1 4LP
Feeeman Hospital
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
About this study
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.
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.
Read the 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.
- Conditions
- Syncope
- Being tested
- Pacemaker implantation (Medtronic), Implantable Loop Recorder (Medtronic)
- Medical subject headings
- Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker implantation (Medtronic)Device
Also called Medtronic DDD+/-R pacemakers
DDD+/-R pacing
Pacemaker implantation (Medtronic)Device
Also called Medtronic DDR+/-R pacemakers.
ODO pacing
Implantable Loop Recorder (Medtronic)Device
Also called Medtronic Reveal DX or XT
Loop recorder implantation
| Study group | Role | What they receive |
|---|---|---|
| Pacemaker "on" | Active comparator | DDD+/-R pacing Receives: Device: Pacemaker implantation (Medtronic) |
| Pacemaker "off" | Placebo comparator | ODO pacing Receives: Device: Pacemaker implantation (Medtronic) |
| Implantable Loop Recorder | Experimental | Implantable loop recorder in adenosine test negative patients Receives: Device: Implantable Loop Recorder (Medtronic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Syncope Burden
Syncope Burden as measured by number of syncopal episodes and recorded by weekly postal patient diaries with telephone reminders to ensure adequate return
Measured: 12 months
Secondary outcomes (5)
Time to first syncope
Time to first syncope
Measured: 12 months
Number of patients with recurrent syncope
Number of patients with >1 episodes of syncope
Measured: 12 months
Quality of life
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
Measured: 12 months
Health economic analysis
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.
Measured: 12 months
ECG diagnosis on ILR following syncopal episode in adenosine negative group
ECG diagnosis on ILR following syncopal episode in intravenous adenosine test negative group
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study start12 Apr 2012
- Primary completion26 Jan 2017
- Study completion26 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyncopeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steve W Parry, PhD, MBBS, MRCP, BSc, Principal investigator, Institue of Ageing and Health, University of NewcastleChris J Pummer, PhD, MRCP, BMBCh, BSc, Principal investigator, Newcastle upon Tyne Hospitals NHS FOundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481168
- Sponsor's protocol ID
- 5883
- Other IDs
- FS/11/13/28690
- Acronym
- ADEPT-ILR
- Status last verified
- Nov 2017
- First submitted
- 22 Nov 2011
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01481168
- Acronym / sponsor ID
- ADEPT-ILR / 5883
- Conditions
- Syncope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Study start
- 12 Apr 2012 (actual)
- Primary completion
- 26 Jan 2017 (actual)
- Study completion
- 26 Jan 2017 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pacemaker "on" | Active comparator | Device: Pacemaker implantation (Medtronic)DDD+/-R pacing |
| Pacemaker "off" | Placebo comparator | Device: Pacemaker implantation (Medtronic)ODO pacing |
| Implantable Loop Recorder | Experimental | Device: Implantable Loop Recorder (Medtronic)Implantable loop recorder in adenosine test negative patients |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacemaker implantation (Medtronic)Also: Medtronic DDD+/-R pacemakersDDD+/-R pacing | Device | Pacemaker "on" |
| Pacemaker implantation (Medtronic)Also: Medtronic DDR+/-R pacemakers.ODO pacing | Device | Pacemaker "off" |
| Implantable Loop Recorder (Medtronic)Also: Medtronic Reveal DX or XTLoop recorder implantation | Device | Implantable Loop Recorder |
Primary outcome
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
5 secondary outcomes
Time to first syncope
Time frame: 12 months
Number of patients with recurrent syncope
Time frame: 12 months
Quality of life
Time frame: 12 months
Health economic analysis
Time frame: 12 months
ECG diagnosis on ILR following syncopal episode in adenosine negative group
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve W Parry, PhD, MBBS, MRCP, BSc principal investigator
Institue of Ageing and Health, University of Newcastle
Chris J Pummer, PhD, MRCP, BMBCh, BSc principal investigator
Newcastle upon Tyne Hospitals NHS FOundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker implantation (Medtronic) and Implantable Loop Recorder (Medtronic) in people with Syncope, run by Newcastle-upon-Tyne Hospitals NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Syncope Burden (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.