Adenosine Testing to DEtermine the Need for Pacing Therapy | NCT01481168

Studies
Adenosine Testing to DEtermine the Need for Pacing Therapy

NCT01481168

Sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Status

Completed

Last Update Posted

Nov 20, 2017Actual

Enrollment

52Actual

Phase

Not Applicable

Conditions

Syncope

Interventions

Pacemaker implantation (Medtronic)
Pacemaker implantation (Medtronic)
Implantable Loop Recorder (Medtronic)

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
FS/11/13/28690	Other Grant/Funding Number	British Heart Foundation

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2012Actual

Primary Completion Date

Jan 26, 2017Actual

Completion Date

Jan 26, 2017Actual

First Submitted Date

Nov 22, 2011

First Submission Date that Met QC Criteria

Nov 28, 2011

First Posted Date

Nov 29, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2017

Last Update Posted Date

Nov 20, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pacemaker "on"	Active Comparator	DDD+/-R pacing	Device: Pacemaker implantation (Medtronic)
Pacemaker "off"	Placebo Comparator	ODO pacing	Device: Pacemaker implantation (Medtronic)
Implantable Loop Recorder	Experimental	Implantable loop recorder in adenosine test negative patients	Device: Implantable Loop Recorder (Medtronic)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pacemaker implantation (Medtronic)	Device	DDD+/-R pacing	Pacemaker "on"

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	12 months

Secondary Outcomes

Measure	Description	Time Frame
Time to first syncope	Time to first syncope	12 months
Number of patients with recurrent syncope	Number of patients with >1 episodes of syncope

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Victoria Infirmary		Newcastle upon Tyne	Tyne and Wear	NE1 4LP	United Kingdom
Feeeman Hospital

Condition Browse Module

MeSH Terms

ID	Term
D013575	Syncope

Ancestor Terms

ID	Term
D014474	Unconsciousness
D003244	Consciousness Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided