Condition category
Circulatory System
Date applied
18/06/2010
Date assigned
18/06/2010
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 Girish G Babu

ORCID ID

Contact details

University College London
Gower Street
London
WC1E 6BT
United Kingdom
g.babu@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5199

Study information

Scientific title

A study investigating the cardioprotective benefits of remote ischaemic postconditioning in different clinical settings of myocardial ischaemia-reperfusion injury

Acronym

Study hypothesis

Aims and 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

Joint UCL/UCLH Committees on Ethics of Human Research (Committee Alpha), 15/09/2005, ref: 05/Q502/102

Study design

Multicentre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/06/2008

Overall trial end date

06/11/2011

Reason abandoned

Eligibility

Participant 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

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 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

Recruitment start date

01/06/2008

Recruitment end date

06/11/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
London
WC1E 6BT
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