Remote ischaemic preconditioning to protect the myocardium during abdominal aortic aneurysm repair
| ISRCTN | ISRCTN48315424 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48315424 |
| Protocol serial number | N0544122070 |
| Sponsor | Department of Health (UK) |
| Funder | Cambridge Consortium - Addenbrookes (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 16/07/2009
- 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
Dr Ziad Ali
Scientific
Scientific
Department of Vascular Surgery
Box 201
Addenbrooke's Hospital
Long Road
Cambridge
CB2 2QQ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Patients undergoing major vascular surgery are at significant risk of developing postoperative myocardial complications, particularly myocardial infarction. Protecting the heart during the perioperative period could provide a method to reduce morbidity and mortality after vascular surgery. Ischaemic preconditioning is a well recognised phenomenon, whereby a brief period of ischaemia followed by reperfusion prior to a prolonged ischaemic event can provide protection from cellular injury. Protection can be performed either by a stimulus to the myocardium itself or by ischaemia at a site distant to the heart. The aim of this study is to determine whether remote ischaemic preconditioning confers a reduction in myocardial damage in patients undergoing abdominal aortic aneurysm repair. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Aortic aneurysm repair |
| Intervention | Randomised controlled trial: 1. Abdominal aortic aneurysm repair alone 2. Abdominal aortic aneurysm repair with intermittent cross clamping/perfusion of common iliac artery Postoperatively, patients will have cardiac troponin and creatine kinase MB (CKMB) recorded on days 1, 3 and 7. Holter monitoring is to be continued until 48 h post operation. |
| Intervention type | Other |
| Primary outcome measure(s) |
A reduction in myocardial damage as assessed by serum measurement of cardiac troponin and Holter electrocardiogram. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 09/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | All |
| Target sample size at registration | 72 |
| Key inclusion criteria | 72 Subjects aged 18-90. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 10/01/2003 |
| Date of final enrolment | 09/01/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Vascular Surgery
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
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? |
|---|---|---|---|---|---|
| Results article | results | 11/09/2007 | Yes | No |
