Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000164594
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
9/05/2006
Date last updated
9/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical & Neurohormonal Prediction Of Outcome In Atrial Fibrillation
Scientific title
A study to assess whether clinical and neurohormal markers can predict the outcome of biphasic versus monsophasic cardioversion for atrial fibrillation.
Universal Trial Number (UTN)
Trial acronym
CHOP-CAF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 1137 0
Condition category
Condition code
Cardiovascular 1217 1217 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will also be randomly assigned to biphasic defibrillation as a single cardioversion procedure which takes about 3-5 minutes.
Intervention code [1] 556 0
None
Comparator / control treatment
Participants will also be randomly assigned to monophasic defibrillation as a single cardioversion procedure which takes about 3-5 minutes.
Control group
Dose comparison

Outcomes
Primary outcome [1] 1648 0
The main aim of this study is to determine whether the hormones atrial natriuretic peptide (ANP) can improve our ability to predict successful cardioversion in atrial fibrillation.
Timepoint [1] 1648 0
Measured prior to cardioversion and again at 6 weeks and 12 months afterwards.
Primary outcome [2] 1649 0
The main aim of this study is to determine whether the hormones brain natriuretic peptide (BNP) can improve our ability to predict successful cardioversion in atrial fibrillation.
Timepoint [2] 1649 0
Measured prior to cardioversion and again at 6 weeks and 12 months afterwards.
Secondary outcome [1] 2947 0
In this study we will try to develop a tool that could help in predicting the short and long term outcome post DC cardioversion for the patients with atrial fibrillation. The tool will incorporate the data collected from the different blood tests and imaging results. It will, also, take in consideration the medical background and pharmacological agents commonly used in this condition.
Compare between 2 different types of defibrillators used to perform DC cardioversion (Monophasic & Biphasic). The aim will be to identify which type of defibrillator has better outcome and less complications.
Record the possible complications associated with atrial fibrillation and its treatment over the follow up period.
Timepoint [1] 2947 0

Eligibility
Key inclusion criteria
Atrial fibrillation or flutter on the waiting list for elective DC cardioversion who are welling to participate and capable of attending follow up appointments.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any patient who is unable or not welling to consent to be enrolled, and patients who can not attend the follow up appointment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by an on-site computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/01/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 216 0
New Zealand
State/province [1] 216 0

Funding & Sponsors
Funding source category [1] 1328 0
Charities/Societies/Foundations
Name [1] 1328 0
Christchurch Cardioendocrine Research Trust
Country [1] 1328 0
New Zealand
Primary sponsor type
University
Name
Christchurch Cardioendocrine Research Group
Address
Country
New Zealand
Secondary sponsor category [1] 1172 0
None
Name [1] 1172 0
Nil
Address [1] 1172 0
Country [1] 1172 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2675 0
Christchurch
Ethics committee address [1] 2675 0
Ethics committee country [1] 2675 0
New Zealand
Date submitted for ethics approval [1] 2675 0
Approval date [1] 2675 0
Ethics approval number [1] 2675 0
CTR/03/07/118

Summary
Brief summary
All patients on the waiting list for elective DC cardiovesion will be offered the chance to participate In this study. If they agree, we will record the results of the different laboratory and imaging tests that they had prior to presenting to the preadmission clinic, as well as each individual medical background.
Each patient will have 4 extra blood tests to measure the hormones produced by the heart and other parts of the body in response to their heart condition. The first 2 tests will be on the day they present for the electric shock treatment (DC cardiovesion). The 3rd when having the 6 weeks routine follow up, and the last one will be when having the 6 months follow up. Each patient will, also, have an additional ultrasound examination of the heart 4-8 months following having the DC cardioversion.
Each patient will be followed for a minimum of 1 year (the 2 other follow ups at 6&12 months post DC cardioversion). During this time we will monitor the heart rhythm, the rate of possible complications with this condition and analyse the data trying to identify the patients who may benefit from this treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35897 0
Address 35897 0
Country 35897 0
Phone 35897 0
Fax 35897 0
Email 35897 0
Contact person for public queries
Name 9745 0
Lorraine Skelton
Address 9745 0
Department of Medicine
Christchurch School of Medicine & Health Sciences
PO Box 4345
Christchurch
Country 9745 0
New Zealand
Phone 9745 0
+64 3 3641063
Fax 9745 0
+64 3 3641115
Email 9745 0
[email protected]
Contact person for scientific queries
Name 673 0
Dr Amjad Hamid
Address 673 0
Christchurch Hospital
PO Box 4710
Christchurch
Country 673 0
New Zealand
Phone 673 0
+64 3 364 0640
Fax 673 0
+64 3 3641115
Email 673 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.