Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000632291
Ethics application status
Not yet submitted
Date submitted
2/07/2009
Date registered
29/07/2009
Date last updated
29/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of intravenous fish oil on the electrical properties of the human atria in patients undergoing elective electrophysiological evaluation and /or radiofrequency ablation of suraventricular or ventricular tachycardia
Scientific title
The effect of intravenous fish oil on the electrical properties of the human atria in patients undergoing elective electrophysiological evaluation and /or radiofrequency ablation of suraventricular or ventricular tachycardia.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac electrophysiology 237105 0
Human atrial electrical properties. 237339 0
Condition category
Condition code
Cardiovascular 237432 237432 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous fish oil.Participants will given a single dose of 100ml/10g (fish oil) of Omegaven . It will be mixed with 250ml 20% intralipid and infused at a rate of 0.5ml/kg/hr
Intervention code [1] 236824 0
Prevention
Comparator / control treatment
Placebo is an intravenous infusion of 250 ml 20% Intralipid given as a single dose over 4hrs .
Control group
Placebo

Outcomes
Primary outcome [1] 238263 0
Change in atrial electrical conduction times .
Timepoint [1] 238263 0
As measured during study protocol.Electrophysiological evaluation will consist of :
Measurement of atrial refractory periods (ERPs) - conducted from three sites distal coronary sinus, right atrial appendage and proximal coronary sinus and at three pacing cycle lengths 600ms, 500ms 400ms using 10ms increments from below refractoriness ( commencing at 150ms).
P wave duration in sinus rhythm .
Atrial conduction times measured at two sites along the coronary sinus(cs) by pacing from the distal bipole of the cs and measuring time to activation at the proximal bipole and at the right atrial appendage pacing the distal bipole from the cs catheter measuring time to activation at distal bipole from a catheter positioned at the right atrial appendage . these times will be measureed at pacing cycle lengths of 600, 500 and 400ms.
Conduction delay at the crista terminalis (ct) which will be assessed during pacing from the distal cs and mid right atrium at cycle lengths of 600,500and 400ms .Conduction delay at the ct will be analyzed by the timing between double potentials at the ct.
Sinus node function. This will be assessed by rapid atrial pacing at cycle lengths of 400 and 400ms to determine corrected sinus node recovery time.
Secondary outcome [1] 244628 0
Prevention of induction of atrial fibrillation during rapid atrial pacing
Timepoint [1] 244628 0
Will consist of atrial pacing at a cycle length of 200ms for 10 seconds at 20mA 10 times during the electrophysiological study.

Eligibility
Key inclusion criteria
Participants recruited from patients undergoing elective electrophysiological evaluation and or radiofrequency ablation of supraventricular or ventricular tachycardia.
They may or may not have impaired ventricular function.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Use of Amiodarone in the previous 6 months.
Patients with known allergies to fish or egg protein

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited from patients undergoing elective electrophysiological evaluation and or radiofrequency ablation for suraventricular or ventricular tachycardia. They have been placed on a hospital waiting list . Approx 50% will come from the hospital outpatient cardiology clinic and 50% from the principal Cardiologists rooms . From the hospital waiting list participants will be approached by either the princial investigater or assistant to establish interest or not.Mostly this will be done over the phone and where approprate the relevant paperwork forwarded.
With regard to randomisation. The study will have two groups . Those who receive fish oil and those who do not . Participants will be randomly allocated to receive fish oil or not using sequentially numbered opaque sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using sequentially numbered opaque sealed envelopes.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1862 0
3050

Funding & Sponsors
Funding source category [1] 237242 0
Self funded/Unfunded
Name [1] 237242 0
Cardiac electrophysiology (EP): Paul Sparks
Country [1] 237242 0
Australia
Funding source category [2] 237243 0
Hospital
Name [2] 237243 0
Royal Melbourne Hospital
Country [2] 237243 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Grattan St
Parkville, VICTORIA 3050
Country
Australia
Secondary sponsor category [1] 236729 0
None
Name [1] 236729 0
Address [1] 236729 0
Country [1] 236729 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239343 0
Human Research and Ethics Committee (HREC) Office for Research Royal Melbourne Hospital
Ethics committee address [1] 239343 0
Ethics committee country [1] 239343 0
Australia
Date submitted for ethics approval [1] 239343 0
23/04/2009
Approval date [1] 239343 0
Ethics approval number [1] 239343 0
2009.076

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29801 0
Address 29801 0
Country 29801 0
Phone 29801 0
Fax 29801 0
Email 29801 0
Contact person for public queries
Name 13048 0
Fiona Sutherland
Address 13048 0
Cardiology Dept
The Royal Melbourne Hospital
Grattan St
Parkville Vic 3050
Country 13048 0
Australia
Phone 13048 0
+61 393427133
Fax 13048 0
+61 393472808
Email 13048 0
[email protected]
Contact person for scientific queries
Name 3976 0
Fiona Sutherland
Address 3976 0
Cardiology Dept
The Royal Melbourne Hospital
Grattan St
Parkville Vic 3050
Country 3976 0
Australia
Phone 3976 0
+61 393427133
Fax 3976 0
+61 393472808
Email 3976 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.