Use of Loop Recorders for Diagnosis of Palpitations in A&E (LIAISE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Barts & The London NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT01170559
First received: July 26, 2010
Last updated: March 21, 2011
Last verified: March 2011

July 26, 2010
March 21, 2011
April 2010
October 2011   (final data collection date for primary outcome measure)
The primary endpoint of the study is the proportion of patients achieving a definite diagnosis in each of the two groups at the end of one year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01170559 on ClinicalTrials.gov Archive Site
  • The time taken from randomisation in the A&E to making the diagnosis (if any) in each group [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • The cost of achieving a diagnosis in each group [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Use of Loop Recorders for Diagnosis of Palpitations in A&E
Use of Implantable Loop Recorders as a Primary Investigation of Infrequent Undiagnosed ArrhythmIa Symptoms in the Emergency Department

Heart rhythm abnormalities underlie one of the common presenting complaints to the A&E and out-patient departments, specifically awareness of heart beats or palpitations. Unless an ECG (electrocardiogram) tracing of the heart rhythm can be recorded while the patient is having symptoms, it is very difficult to determine the cause of the palpitations. The conventional approach is to refer these patients from the emergency departments to the Cardiology outpatients where they undergo repeated short term rhythm monitoring hoping to record the rhythm underlying the patient's complaint. Unfortunately, this often yields no results thus delaying definitive treatment and incurring extra costs of repeated investigations and A&E presentations. This study aims to compare the ability of the conventional approach to establish a definite diagnosis compared to that of an early invasive monitoring approach with a small implantable device that records the heart rhythm at all time for up to 18 months.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Palpitations
Device: Implantable Loop Recorder
Other Name: Reveal XT
  • Experimental: Group 1: ILR Group
    Group allocated to receiving an ILR in the A&E department.
    Intervention: Device: Implantable Loop Recorder
  • No Intervention: Group 2: Conventional
    Group randomised to conventional lines of investigation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
56
Not Provided
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 years or older
  • Good history of episodic symptomatic sustained palpitations (sudden onset and offset, fast heart beats, may be associated with shortness of breath or dizziness)
  • Terminates before presentation to hospital
  • Episodes occur at a frequency of less than once every two weeks
  • Never previously caught on ECG or ambulatory monitoring
  • Normal resting ECG

Exclusion Criteria:

  • Contraindication to ILR implantation i.e. ongoing oral anticoagulation with INR >1.6, ongoing infection, sepsis or fever, etc.
  • Palpitations suggestive of extrasystoles (single missed or dropped beats)
  • Known or suspected severe valvular or myocardial heart disease

    • An audible heart murmur
    • Any abnormality on the surface ECG
  • Thyrotoxicosis
  • Patients who refuse an ILR when offered will not be included in either limb of the study
Both
18 Years and older
No
Contact: Richard Schilling, MD, FRCP +442076018639 r.schilling@qmul.ac.uk
United Kingdom
 
NCT01170559
006628 BLT
No
Professor Richard Schilling, Barts and the London NHS Trust/ Queen Mary University of London
Barts & The London NHS Trust
Not Provided
Principal Investigator: Richard Schilling, MD, FRCP Barts and the London NHS Trust, Queen Mary University of London
Barts & The London NHS Trust
March 2011

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