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
Secondary identifying numbers	N0436121377

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

Dr SY Ooi
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 design	Randomised active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Not Specified
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	Cytokine levels measured in the blood peripheral venous blood
Secondary outcome measures	Not provided at time of registration
Overall study start date	31/10/2002
Completion date	31/10/2005

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Not provided at time of registration
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

Institute for Cardiovascular Research

Leeds
LS1 3EX
United Kingdom

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Hospital/treatment centre

Leeds Teaching Hospitals NHS Trust (UK)

No information available

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