Condition category
Circulatory System
Date applied
28/05/2010
Date assigned
28/05/2010
Last edited
27/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vinod Venugopal

ORCID ID

Contact details

Hatter Cardiovascular Institute
13-15 Gower Street
London
WC1E 6HE
United Kingdom
v.venugopal@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5201

Study information

Scientific title

A clinical study investigating myocardial preconditioning in Type II diabetic patients in the setting of coronary artery bypass surgery

Acronym

Study hypothesis

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

Joint UCL/UCLH Committees on Ethics of Human Research (Committee Alpha), 05/07/2001, ref: 01/0128

Study design

Single-centre randomised interventional prevention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

20/02/2006

Overall trial end date

01/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged greater than 18 years
2. Patients undergoing coronary bypass surgery with or without concomitant heart valve surgeries
3. Male and female patients

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 500

Participant exclusion criteria

1. Aged less than 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

Recruitment start date

20/02/2006

Recruitment end date

01/06/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hatter Cardiovascular Institute
London
WC1E 6HE
United Kingdom

Sponsor information

Organisation

University College London (UCL) (UK)

Sponsor details

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

Sponsor type

University/education

Website

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

Funders

Funder type

Charity

Funder name

British Heart Foundation (BHF) (UK)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes