Characterisation of the cytokine response in the Acute Coronary Syndrome and its modulation with angiotensin-converting enzyme inhibition (Protocol B)
| ISRCTN | ISRCTN51684951 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51684951 |
| Protocol serial number | N0436121377 |
| Sponsor | Department of Health (UK) |
| Funder | Leeds Teaching Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 16/08/2012
- 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 SY Ooi
Scientific
Scientific
Institute for Cardiovascular Research
G Floor, Jubilee Building
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
| Phone | +44 (0)113 392 5404 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To define the effects that angiotensin-converting enzyme inhibitors have on circulating levels of the pro-inflammatory cytokines; tumour necrosis factor (TNF)-alpha and interleukin-6 (IL-6), and the anti-inflammatory cytokine; IL-10. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Acute coronary syndrome |
| Intervention | Randomised controlled trial. Random allocation to: 1. Standard management 2. Standard management + angiotensin-converting enzyme inhibitor |
| Intervention type | Other |
| Primary outcome measure(s) |
Cytokine levels measured in the blood peripheral venous blood |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Key inclusion criteria | The patient population will be drawn from all patients admitted to the cardiac unit based at the Leeds General Infirmary or St James's University Hospital with chest pain within the preceding 24 h. Patients must have a history and electrocardiogram (ECG) changes consistent with a diagnosis of the Acute Coronary Syndrome. |
| Key exclusion criteria | Patients with ST elevation myocardial infarction |
| Date of first enrolment | 31/10/2002 |
| Date of final enrolment | 31/10/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Institute for Cardiovascular Research
Leeds
LS1 3EX
United Kingdom
LS1 3EX
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 |
