Remote ischaemic postconditioning in the clinical setting

ISRCTN	ISRCTN78348355
DOI	https://doi.org/10.1186/ISRCTN78348355
Secondary identifying numbers	5199

Submission date: 18/06/2010
Registration date: 18/06/2010
Last edited: 11/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Girish G Babu
Scientific

University College London
Gower Street
London
WC1E 6BT
United Kingdom

Email	g.babu@ucl.ac.uk

Study information

Study design	Multicentre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A study investigating the cardioprotective benefits of remote ischaemic postconditioning in different clinical settings of myocardial ischaemia-reperfusion injury
Study objectives	The study proposes to examine the cardioprotective potential of 'remote ischaemic postconditioning' in the clinical setting of percutaneous coronary angioplasty using transient fore-arm ischaemia.
Ethics approval(s)	Joint UCL/UCLH Committees on Ethics of Human Research (Committee Alpha), 15/09/2005, ref: 05/Q502/102
Health condition(s) or problem(s) studied	Topic: Cardiovascular, Neurological; Subtopic: Cardiovascular (all Subtopics), Neurological (all Subtopics); Disease: Cardiovascular, Nervous system disorders
Intervention	Control arm: Uninflated blood pressure cuff will be placed on the patients's upper arm for the duration of 30 minutes. Intervention arm: Inflation of a blood pressure cuff placed around the upper arm. The cuff will be inflated to 200 mmHg for 5 minutes after which it will be deflated for 5 minutes. This procedure will be repeated up to three times in total based on randomisation protocol.
Intervention type	Other
Primary outcome measure	Myocardial injury, measured by cTnT and CK-MB release over 24 hours after PCI.
Secondary outcome measures	1. All-cause mortality, recurrence of symptoms, heart failure and hospitalisation at 1 year after primary percutaneous coronary intervention (PCI) 2. Major adverse cardiovascular events (MACE) at 1 year 3. Myocardial infarct size, 3 months after primary PCI as measured by cardiac magnetic resonance imaging (MRI) 4. Myocardial infarct size and myocardial salvage ratio (infarct size/area at risk) as measured by cardiac MRI
Overall study start date	01/06/2008
Completion date	06/11/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 500
Key inclusion criteria	1. Patients undergoing percutanous coronary interventions in the elective and emergecy setting and patients undergoing thrombolysis for acute myocardial infarction 2. Aged greater than 18 years and less than 85 years 3. Male and female patients
Key exclusion criteria	1. Aged less than 18 years and greater than 85 years 2. Patients with severe renal impairment (estimated glomerular filtration rate [EGFR] less than 45 ml/min/1.73m2) 3. Patients with severe hepatic impairment 4. Patients with cardiac arrest in the previous 6 weeks
Date of first enrolment	01/06/2008
Date of final enrolment	06/11/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University College London

London
WC1E 6BT
United Kingdom

Sponsor information

University College London (UCL) (UK)
University/education

UCL Biomedicine Research & Development Unit
Maple House
149 Tottenham Court Road
London
W1T 7NF
England
United Kingdom

Website	http://www.ucl.ac.uk/
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Charity

British Heart Foundation (BHF) (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): the_bhf, The British Heart Foundation, BHF
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

11/04/2017: No publications found, verifying study status with principal investigator.