Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000486426
Ethics application status
Approved
Date submitted
3/03/2015
Date registered
13/04/2016
Date last updated
11/10/2022
Date data sharing statement initially provided
11/10/2022
Date results provided
11/10/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Remote ischaemic preconditioning and its effect on coronary physiology and platelet & leukocyte activation
Scientific title
Remote ischaemic preconditioning and its effect on coronary physiology and platelet & leukocyte activation in patients with suspected coronary artery disease undergoing coronary angiography.
Secondary ID [1] 286308 0
Nil
Universal Trial Number (UTN)
Trial acronym
RIPPLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 294407 0
Condition category
Condition code
Cardiovascular 294713 294713 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will have remote ischaemic preconditioning delivered which involves inflating a sphygmomanometer to supra-systolic pressures around their arm. The sphygmomanometer will be inflated to 200mmHg or 50mmHg above systolic blood pressure for 5 minutes then deflated for 5 minutes. This cycle will be repeated 3 times. The treatment will be administered by a member of the research team. The participant will undergo the planned medical procedure after the remote ischaemic preconditioning.
Intervention code [1] 291351 0
Treatment: Other
Comparator / control treatment
Sham remote ischaemic preconditioning will be delivered in an identical manner to remote ischaemic preconditioning except that the sphygmomanometer will be inflated to 10mmHg.
Control group
Placebo

Outcomes
Primary outcome [1] 294475 0
Changes to measures of coronary artery flow as assessed with the use of a coronary pressure sensor wire.
Timepoint [1] 294475 0
Immediately after remote ischaemic preconditioning/sham
Primary outcome [2] 294610 0
Markers of platelet and leukocyte activation assessed by performing flow cytometry on blood samples collected from the patient. This is a composite outcome.
Timepoint [2] 294610 0
Immediately after remote ischaemic preconditioning/sham
Secondary outcome [1] 313406 0
Nil
Timepoint [1] 313406 0
Nil

Eligibility
Key inclusion criteria
Patients listed for coronary angiography +/- angioplasty and stenting
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications to remote ischaemic preconditioning- clinically unstable, peripheral vascular disease of upper limb, AVF in left arm, contraindications to adenosine, unable to co-operate/ consent, pre-existing neuropathy or myopathy

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/10/2014
Actual
17/10/2014
Date of last participant enrolment
Anticipated
Actual
26/08/2019
Date of last data collection
Anticipated
Actual
26/08/2019
Sample size
Target
100
Accrual to date
Final
153
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290878 0
Other
Name [1] 290878 0
ANZAC research institute
Country [1] 290878 0
Australia
Primary sponsor type
Other
Name
ANZAC research institute
Address
Hospital road Concord 2139 NSW
Country
Australia
Secondary sponsor category [1] 289563 0
None
Name [1] 289563 0
Address [1] 289563 0
Country [1] 289563 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292483 0
Sydney local health district HREC
Ethics committee address [1] 292483 0
Ethics committee country [1] 292483 0
Date submitted for ethics approval [1] 292483 0
Approval date [1] 292483 0
06/06/2014
Ethics approval number [1] 292483 0

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

Contacts
Principal investigator
Name 55514 0
Prof Leonard Kritharides
Address 55514 0
Level 3 west, Cardiology department, Concord Hospital
Hospital road Concord NSW 2139
Country 55514 0
Australia
Phone 55514 0
(+612) 97676296
Fax 55514 0
Email 55514 0
[email protected]
Contact person for public queries
Name 55515 0
Gabrielle Pennings
Address 55515 0
Level 3 west, Cardiology department, Concord Hospital
Hospital road Concord NSW 2139
Country 55515 0
Australia
Phone 55515 0
(+612) 97676296
Fax 55515 0
Email 55515 0
[email protected]
Contact person for scientific queries
Name 55516 0
Gabrielle Pennings
Address 55516 0
Level 3 west, Cardiology department, Concord Hospital
Hospital road Concord NSW 2139
Country 55516 0
Australia
Phone 55516 0
(+612) 97676296
Fax 55516 0
Email 55516 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
only aggregate data will be available


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
SourceTitleYear of PublicationDOI
EmbaseRemote ischemic preconditioning acutely improves coronary microcirculatory function.2018https://dx.doi.org/10.1161/JAHA.117.009058
N.B. These documents automatically identified may not have been verified by the study sponsor.