Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
11/04/2014
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 B Matata

ORCID ID

Contact details

University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0123138565

Study information

Scientific title

Acronym

Study hypothesis

1. To study the mechanism by which inflammatory response to cardiopulmonary bypass is modulated by oxidant stress
2. To use an ex-vivo model of cardiopulmonary bypass (CPB) and blood samples from patients to investigate oxygen free radicals on the pathogenesis

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

Surgery: Cardiovascular

Intervention

The project is composed of laboratory based investigation and the molecular changes associated with the re-circulation of blood in an artificial surface will be studied using a surrogate model of CPB. A total of 400 patients will be randomised to one of the groups: IHD with and without Hypertension, IHD with and without Hypercholesterolemia, IHD with and without Diabetes, Healthy control.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Proinflammatory cytokines, antioxidant capacity, oxygen free radicals and clinical outcomes.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

05/12/2003

Overall trial end date

30/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with ischaemic heart disease (IHD) scheduled for elective cardiac operations will be selected.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

05/12/2003

Recruitment end date

30/09/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

University Hospitals of Leicester 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