Myocardial preconditioning in coronary artery bypass surgery
| ISRCTN | ISRCTN01775128 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01775128 |
| Protocol serial number | 5201 |
| Sponsor | University College London (UCL) (UK) |
| Funder | British Heart Foundation (BHF) (UK) |
- Submission date
- 28/05/2010
- Registration date
- 28/05/2010
- Last edited
- 06/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Vinod Venugopal
Scientific
Scientific
Hatter Cardiovascular Institute
13-15 Gower Street
London
WC1E 6HE
United Kingdom
| v.venugopal@ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised interventional prevention trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A clinical study investigating myocardial preconditioning in Type II diabetic patients in the setting of coronary artery bypass surgery |
| Study objectives | 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(s) | Joint UCL/UCLH Committees on Ethics of Human Research (Committee Alpha), 05/07/2001, ref: 01/0128 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Myocardial injury, assessed by Troponin T and creatine kinase myocardial band (CK-MB) levels over the 72 hours post-CABG surgery. |
| Key secondary outcome measure(s) |
1. Ionotropic score, measured at first week post-operative period |
| Completion date | 01/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 500 |
| Key inclusion criteria | 1. Aged over 18 years 2. Patients undergoing coronary bypass surgery with or without concomitant heart valve surgeries 3. Male and female patients |
| Key exclusion criteria | 1. Aged under 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 |
| Date of first enrolment | 20/02/2006 |
| Date of final enrolment | 01/06/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Hatter Cardiovascular Institute
London
WC1E 6HE
United Kingdom
WC1E 6HE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/04/2017: No publications found, verifying study status with principal investigator.
