Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr SY Ooi

ORCID ID

Contact details

Institute for Cardiovascular Research
G Floor
Jubilee Building
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 392 5404

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436121377

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

Acute coronary syndrome

Intervention

Randomised controlled trial. Random allocation to:
1. Standard management
2. Standard management + angiotensin-converting enzyme inhibitor

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Cytokine levels measured in the blood peripheral venous blood

Secondary outcome measures

Not provided at time of registration

Overall trial start date

31/10/2002

Overall trial end date

31/10/2005

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Patients with ST elevation myocardial infarction

Recruitment start date

31/10/2002

Recruitment end date

31/10/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute for Cardiovascular Research
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes