Condition category
Circulatory System
Date applied
28/06/2013
Date assigned
28/06/2013
Last edited
09/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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?
The study will take place at the Heart Hospital UCLH, Basildon & Thurrock University Hospital and East Surrey Hospital.

When is the study starting and how long is it expected to run for?
Study will run from 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?
Professor 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.

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=14361

On 09/01/2015 the following changes were made to the trial record:
1. The overall trial end date was changed from 01/12/2014 to 01/03/2017.
2. The trial was changed from a single-centre to a multi-centre trial with the addition of two new participating centres: Basildon & Thurrock University Hospital and East Surrey Hospital.

Ethics approval

NRES Committee London - Queen Square, 13.LO.0502; First MREC approval date 04/06/2013

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 below 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 measures

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

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 one month

Recruitment start date

01/05/2013

Recruitment end date

01/12/2016

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

http://www.ucl.ac.uk/

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

foundation

Location

United Kingdom

Funder name

University College London Hospitals NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24292557

Publication citations

  1. 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

Editorial Notes