Plain English Summary
Background and study aims
The objective of this study is to investigate whether a new intervention called 'Remote Ischaemic PreConditioning' (RIPC) can reduce the incidence of contrast nephropathy, an acute kidney injury caused by the contrast medium (a substance used to enhance the contrast of structures or fluids within the body in medical imaging) that is used during coronary angiography and angioplasty. It is thought that the contrast medium damages the kidney by reducing kidney blood flow as well as by a direct toxic effect. It is known that an already existing kidney dysfunction is the main pre procedure risk factor for contrast induced kidney injury in addition to a number of other factors such as age over 75, diabetes, anaemia and heart failure. RIPC is a new concept which involves repeated inflation of a blood pressure cuff on the upper arm or leg to cause reduced blood flow and a local oxygen shortage (ischaemia) in the arm or leg tissue. It is thought that the 'ischaemic' tissues release pro survival proteins which also protect other organs in the body from reduced blood flow. Several studies have shown a protective effect in a number of situations including during heart attacks and heart surgery. To date, two small studies have suggested that RIPC can reduce the incidence of contrast nephropathy.
Who can participate?
Male and female patients between the age of 18 and 85, who are awaiting coronary angiography or angioplasty, are able to give informed consent and who have reduced kidney function. The study aims to recruit 360 patients.
What does the study involve?
Patients will be randomly allocated to receive either the 'remote ischaemic preconditioning' treatment or a placebo (dummy). Both groups will then undergo the planned coronary angiogram or angioplasty with the standard measures taken to reduce the risk of an acute kidney injury. Blood and urine tests will be collected prior to and after the procedure to assess whether the treatment has been effective in preventing damage to the patients' kidneys. Patients will be followed up at three months to assess whether there has been any persistent kidney injury or cardiovascular events.
What are the possible benefits and risks of participating?
The benefit of the study will be an increase in the scientific understanding of how RIPC may lead to a reduction in contrast medium induced nephropathy (CIN) and cardiovascular outcomes, as suggested by previous studies. RIPC is known to be a safe intervention with no documented significant adverse effects. Some patients have reported mild discomfort or minor skin bruising at the cuff site during cuff inflation which is temporary.
Where is the study run from?
1. Heart Hospital UCLH (UK)
2. Basildon & Thurrock University Hospital (UK)
3. East Surrey Hospital (UK)
When is the study starting and how long is it expected to run for?
July 2013 to April 2017
Who is funding the study?
The study is being funded by The Hatter Cardiovascular Institute, UCL, as part of a BHF programme grant
Who is the main contact?
Prof. Derek Yellon
d.yellon@ucl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Derek Yellon
ORCID ID
Contact details
The Hatter Institute for Cardiovascular Studies
25 Grafton Way
London
WC1E 6DB
United Kingdom
-
d.yellon@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
14361
Study information
Scientific title
A single-centre double-blinded randomised placebo-controlled study investigating the Effect of Remote Ischaemic preConditioning on Contrast medium Induced Nephropathy in at-risk patients undergoing coronary angiography or PCI (ERICCIN)
Acronym
ERICCIN
Study hypothesis
Remote Ischaemic Preconditioning reduces the incidence of contrast nephropathy in at-risk individuals undergoing coronary angiography or angioplasty.
Ethics approval
NRES Committee London - Queen Square, 04/06/2013, ref: 13.LO.0502
Study design
Randomised interventional prevention trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet: Ms Liz Owen, The Hatter Cardiovascular Institute, 67 Chenies Mews, London WC1E 6HX
Condition
Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular
Intervention
Suitable participants awaiting coronary angiography or angioplasty who have impaired kidney function will be stratified into high, medium and low risk groups and then randomly assigned in blocks to receive either the 'remote ischaemic preconditioning' treatment or a placebo.
Remote Ischaemic Conditioning, BP cuff inflation on the upper arm to 200mmHg for 5 minutes followed by deflation for 5 minutes. In total four cycles of inflation/deflation administered.
Follow Up Length: 3 months
Study Entry : Single Randomisation only
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Contrast Induced Nephropathy; Timepoint(s): Incidence of creatinine elevation by 25% or 0.5g/dl from baseline at 48 hours.
Secondary outcome measures
1. Cardiovascular endpoints; death, MI, revasc, acute heart failure, haemorrhage, rehospitalisation, haemodialysis at 3 months
2. Neutrophil gelatinase-associated lipocalin (NGAL); Timepoint(s): Serum NGAL elevation from baseline at 6 hours post contrast exposure
3. Persistent CIN; Timepoint(s): Incidence of creatinine elevation by 25% / 0.5g/dl from baseline at 3 months post contrast exposure
4. Proteinuria; Timepoint(s): Elevation of dipstick protein and ACR at 48 hours and 3 months following contrast exposure
Overall trial start date
01/05/2013
Overall trial end date
01/03/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 18 to 85
2. Male or female gender
3. Awaiting coronary angiography or percutaneous coronary intervention, or (added 09/01/2015) CRTD implantation
4. Renal dysfunction with eGFR (MDRD) <60 ml/min/1.73m2
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 362; UK Sample Size: 362; Description: Patients awaiting elective or emergency coronary angiography/PCI/CRTD with baseline eGFR (MDRD) <60 ml/min
Participant exclusion criteria
1. Age under 18 or over 85
2. Inability to give written informed consent
3. Pregnancy
4. Haemo or peritoneal dialysis patients
5. Contraindication to BP cuff inflation such as significant upper limb peripheral vascular disease
6. Coagulopathy with INR >2.0
7. ST elevation MI/cardiac arrest/cardiogenic shock during admission
8. Participation in another clinical trial within 3 months
9. Intravascular Contrast Exposure within prior 1 month
Recruitment start date
14/08/2013
Recruitment end date
28/10/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Heart Hospital, University College London Hospitals
16-18 Westmoreland Street
London
W1G 8PH
United Kingdom
Trial participating centre
Basildon & Thurrock University Hospital
Basildon
SS16 5NL
United Kingdom
Trial participating centre
East Surrey Hospital
Canada Avenue
Redhill
RH1 5RH
United Kingdom
Sponsor information
Organisation
University College London (UK)
Sponsor details
Gower Street
London
WC1E 6BT
United Kingdom
-
david.wilson@ucl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation (BHF) (UK) Grant Codes: RG/08/015/26411
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
United Kingdom
Funder name
University College London Hospitals NHS Foundation Trust
Alternative name(s)
UCLH
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The trialists intend to publish the study findings in a high-impact peer reviewed journal shortly.
IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository at The Hatter Cardiovascular Institute, UCLH. In accordance with its current Records Retention Schedule, research data is retained by UCL as sponsor for 20 years after the research has ended. The UCL Records Office provides a service to UCL staff and maintains records in a safe and secure offsite location and access to stored records is strictly controlled.
Intention to publish date
Participant level data
Stored in repository
Basic results (scientific)
See additional file ISRCTN49645414_BasicResults_14May18.pdf
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24292557
Publication citations
-
Protocol
Bell RM, Rear R, Cunningham J, Dawnay A, Yellon DM, Effect of remote ischaemic conditioning on contrast-induced nephropathy in patients undergoing elective coronary angiography (ERICCIN): rationale and study design of a randomised single-centre, double-blind placebo-controlled trial., Clin Res Cardiol, 2014, 103, 3, 203-209, doi: 10.1007/s00392-013-0637-3.
Additional files
- ISRCTN49645414_BasicResults_14May18.pdf Uploaded 14/05/2018