Contact information
Type
Scientific
Primary contact
Prof Derek Yellon
ORCID ID
Contact details
The Hatter Institute for Cardiovascular Studies
25 Grafton Way
London
WC1E 6DB
United Kingdom
d.yellon@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4058
Study information
Scientific title
A multicentre randomised interventional treatment trial to explore the mechanistic pathway of ischaemic preconditioning and postconditioning in the clinical settings of myocardial ischaemia-reperfusion injury
Acronym
ACE - CABG/PPCI
Study hypothesis
The aim of the study is use pharmacological agents that have been shown to activate survival kinases and inhibit mPTP opening to explore the mechanistic pathway of ischaemic preconditioning and postconditioning in the clinical settings of myocardial ischaemia-reperfusion injury. Patients who are due to undergo planned cardiac surgery will be recuited to receive an interventional agent. These patients will be randomised and compared against a group of controls. Blood tests would be taken post-operatively to assess the primary end points.
Ethics approval
The Joint UCL/UCLH Committees on the Ethics of Human Research Committee (Alpha) approved on the 23/11/2006 (ref: 06/Q0502/83)
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; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular
Intervention
1. Intervention 1: Cyclosporin A at dose of 2.5 mg/kg; diluted in 100 ml of normal saline. Once only dose given over 30 minutes prior to surgery.
2. Intervention 2: Atorvastatin at a dose of 160 mg; given on the morning of surgery and a second dose of 160 mg repeated 24 hours later
3. Intervention 3: Erythropoietin at a dose of 50,000 IU; given as an infusion of 50 ml over 30 minutes prior to revascularisation. A second dose is repeated 24 hours later.
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
Serum cTnT and CK-MB (bloods taken before intervention and at 6, 12, 24, 48 and 72 hours post-intervention).
Secondary outcome measures
1. Inotropic score: calculated using the maximum inotropic dose used on day 1 post-op
2. Ventilation time: assessed from the time of admission into ITU to the time of extubation
3. ITU stay: assessed from the time of admission into ITU to the time of discharge from the unit
Overall trial start date
01/06/2007
Overall trial end date
30/06/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients experiencing an event or procedure which will bring about myocardial injury:
1. Coronary artery bypass surgery +/- valve surgery
2. Primary angioplasty for ST elevation myocardial infarction
3. Thrombolysis for ST elevation myocardial infarction
4. Non-ST elevation myocardial infarction
5. High risk and undergoing percutaneous coronary intervention
6. Aged 18 - 85 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 400
Participant exclusion criteria
1. Significant co-morbidity
2. Known intolerance to trialled intervention
3. Renal/liver failure
4. In patients undergoing an elective procedure-chest pain within the last 3 days, lack of consent
Recruitment start date
01/06/2007
Recruitment end date
30/06/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Hatter Institute for Cardiovascular Studies
London
WC1E 6DB
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
Trusts, charities, foundations (both publically funded and privately funded)
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
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24488610
Publication citations
-
Results
Hausenloy Dj, Kunst G, Boston-Griffiths E, Kolvekar S, Chaubey S, John L, Desai J, Yellon D, The effect of cyclosporin-A on peri-operative myocardial injury in adult patients undergoing coronary artery bypass graft surgery: a randomised controlled clinical trial., Heart, 2014, 100, 7, 544-549, doi: 10.1136/heartjnl-2013-304845.