Myocardial preconditioning in coronary artery bypass surgery

ISRCTN	ISRCTN01775128
DOI	https://doi.org/10.1186/ISRCTN01775128
Secondary identifying numbers	5201

Submission date: 28/05/2010
Registration date: 28/05/2010
Last edited: 06/04/2017

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 Vinod Venugopal
Scientific

Hatter Cardiovascular Institute
13-15 Gower Street
London
WC1E 6HE
United Kingdom

Email	v.venugopal@ucl.ac.uk

Study information

Study design	Single-centre randomised interventional prevention trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A clinical study investigating myocardial preconditioning in Type II diabetic patients in the setting of coronary artery bypass surgery
Study objectives	Aims and objectives: 1. Does remote ischaemic preconditioning (RIPC) using brief upper-limb ischaemia reduce myocardial injury in diabetic patients undergoing coronary artery bypass grafting (CABG) surgery? Previous animal studies suggest that the diabetic heart may be resistant to cardioprotection elicited by preconditioning. 2. How many cycles of brief upper-limb ischaemia and reperfusion are required to reduce myocardial injury in patients undergoing elective CABG surgery? We currently use three cycles of 5 minutes upper-limb ischaemia to elicit RIPC, but it is unknown whether one or two cycles would be sufficient to reduce myocardial injury in patients undergoing elective CABG surgery.
Ethics approval(s)	Joint UCL/UCLH Committees on Ethics of Human Research (Committee Alpha), 05/07/2001, ref: 01/0128
Health condition(s) or problem(s) studied	Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular
Intervention	The stimulus for RIPC that will be used will be 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 upto three times in total based on randomisation protocol. In the control arm, an uninflated blood pressure cuff will be placed on the patients's upper arm for the duration of 30 minutes.
Intervention type	Other
Primary outcome measure	Myocardial injury, assessed by Troponin T and creatine kinase myocardial band (CK-MB) levels over the 72 hours post-CABG surgery.
Secondary outcome measures	1. Ionotropic score, measured at first week post-operative period 2. Ventilation times, measured at the timepoint when patients are weaned from ventilator in the ITU (first 2 days post-operative period) 3. Intensive care unit (ITU) stay, measured at first week post-operative period
Overall study start date	20/02/2006
Completion date	01/06/2011

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. Aged over 18 years 2. Patients undergoing coronary bypass surgery with or without concomitant heart valve surgeries 3. Male and female patients
Key exclusion criteria	1. Aged under 18 years 2. Patients with severe renal impairment (estimated glomerular filtration rate 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	20/02/2006
Date of final enrolment	01/06/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Hatter Cardiovascular Institute

London
WC1E 6HE
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

06/04/2017: No publications found, verifying study status with principal investigator.