Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000142639
Ethics application status
Approved
Date submitted
31/01/2014
Date registered
5/02/2014
Date last updated
5/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of intravenous caffeine on Fractional Flow Reserve measurements in coronary artery disease
Scientific title
To compare fractional flow reserve (FFR) before and after intravenous caffeine administration in coronary artery disease patients to evaluate effect of caffeine on FFR levels
Secondary ID [1] 284021 0
Nil
Universal Trial Number (UTN)
U1111-1152-8715
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease
 291062 0
Ischaemic heart disease 291083 0
Condition category
Condition code
Cardiovascular 291405 291405 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fractional flow reserve measurements performed as clinically required.
intravenous caffeine administration 4mg/kg (maximum 400 mg IV)
Repeat fractional flow reserve measurements 10 minutes after caffeine administration
Intervention code [1] 288707 0
Diagnosis / Prognosis
Comparator / control treatment
Patients prior FFR measurements serve as control measurement, second FFR measurement done post caffeine administration
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291394 0
Any statistical significant change FFR measurements after caffeine administration.
Timepoint [1] 291394 0
After completion of second FFR measurement.
Secondary outcome [1] 306661 0
Any clinically significant change in FFR measurements. (defined as crossing cutoff values of 0.80; i.e.: decrease in FFR above 0.80 to below 0.80)
Timepoint [1] 306661 0
After completion of second FFR measurement.

Eligibility
Key inclusion criteria
Moderate coronary artery disease requiring FFR measurements.
FFR measurement <0.90
Valid consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give informed consent
Caffeine contraindicated
Adenosine contraindicated

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
As patients serve as their own control; no allocation concealment procedures will need to be applied.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Students T test will be used to compare two groups (pre and post caffeine administration.)
This is a proof of concept trial ; and will help determine number needed for a larger randomised trial

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2011
Actual
5/12/2011
Date of last participant enrolment
Anticipated
1/03/2012
Actual
15/06/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2030 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 7731 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 288647 0
Hospital
Name [1] 288647 0
The Northern Hospital
Country [1] 288647 0
Australia
Primary sponsor type
Hospital
Name
The Northern Hospital
Address
185 Cooper Street
Epping Vic 3076
Country
Australia
Secondary sponsor category [1] 287358 0
None
Name [1] 287358 0
Address [1] 287358 0
Country [1] 287358 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290498 0
The Northern Health HREC
Ethics committee address [1] 290498 0
185 Cooper Street
Epping vic 3076
Ethics committee country [1] 290498 0
Australia
Date submitted for ethics approval [1] 290498 0
01/11/2011
Approval date [1] 290498 0
18/11/2011
Ethics approval number [1] 290498 0
P18/11

Summary
Brief summary
Intravenous adenosine is used to minimize the coronary micro-resistance to achieve maximal hyperemia along with nitrates for optimal fractional flow reserve (FFR) measurements. We hypothesize that caffeine, being a competitive inhibitor of adenosine, would influence adenosine mediated FFR readings.

Consecutive patients undergoing angiogram and FFR measurements were enrolled after abstaining from caffeine for 24 hours. Patients with any contraindications to intravenous adenosine or caffeine were excluded. FFR measurements were taken using nitrates and adenosine pre and post 4mg/kg intravenous caffeine administration and results were compared.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45970 0
A/Prof William J van Gaal
Address 45970 0
The Northern Hospital
185 Cooper street
Epping
Vic 3076
Country 45970 0
Australia
Phone 45970 0
+61384058389
Fax 45970 0
Email 45970 0
[email protected]
Contact person for public queries
Name 45971 0
Dr Vivek Mutha
Address 45971 0
The Northern Hospital
185 Cooper street
Epping
Vic 3076
Country 45971 0
Australia
Phone 45971 0
+61384058000
Fax 45971 0
Email 45971 0
[email protected]
Contact person for scientific queries
Name 45972 0
Dr Vivek Mutha
Address 45972 0
The Northern Hospital
185 Cooper street
Epping
Vic 3076
Country 45972 0
Australia
Phone 45972 0
+61384058000
Fax 45972 0
Email 45972 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.