Elucidating the mechanistic pathways of ischaemic preconditioning and postconditioning in the clinical setting
| ISRCTN | ISRCTN49989273 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49989273 |
| Secondary identifying numbers | 4058 |
- Submission date
- 18/06/2010
- Registration date
- 18/06/2010
- Last edited
- 07/03/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Derek Yellon
Scientific
Scientific
The Hatter Institute for Cardiovascular Studies
25 Grafton Way
London
WC1E 6DB
United Kingdom
| d.yellon@ucl.ac.uk |
Study information
| Study design | Multicentre randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | ACE - CABG/PPCI |
| Study objectives | 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(s) | The Joint UCL/UCLH Committees on the Ethics of Human Research Committee (Alpha) approved on the 23/11/2006 (ref: 06/Q0502/83) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/06/2007 |
| Completion date | 30/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 400 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2007 |
| Date of final enrolment | 30/06/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Hatter Institute for Cardiovascular Studies
London
WC1E 6DB
United Kingdom
WC1E 6DB
United Kingdom
Sponsor information
University College London (UCL) (UK)
University/education
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)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2014 | Yes | No |
