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
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 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
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