Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
06/08/2008
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

Prof Petros Nihoyannopoulos

ORCID ID

Contact details

Echocardiology Department
Cardiology
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
+44 020 8383 3948
petros@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0016121116

Study information

Scientific title

Acronym

Study hypothesis

Are the cytokines elevated during stress?

Ethics approval

Added 24 July 2008:
Approval granted by Hammersmith, Queen Charlotte's & Chelsea and Acton Hospital Research Ethics Committee.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cardiovascular: Myocardial ischaemia

Intervention

Treadmill Stress vs Pharmacological Stress (Dobutamine)

Intervention type

Drug

Phase

Not Specified

Drug names

Dobutamine

Primary outcome measures

To assess the plasma levels of interleukin-6 (IL6), tumour necrosis factor alpha (TNFa), tissue factor (TF) and heat shock protein 60 (hsp60). Two stress methods will be employed. While IL6 can also be increased with perpheral muscle stress produced by exercise, dobutamine could induce a smaller ischaemic burden. The two tests therefore will be performed in each patient in order to link cytokines to ischaemia alone.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

02/09/2002

Overall trial end date

10/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Added 24 July 2008:
Patients with greater than or equal to 1 flow-limiting coronary artery stenosis, stable symptoms & ST segment depression on exercise testing (if there is one prior to angiogram)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

Added 24 July 2008:
Control subjects with low pre-exercise test probability of CAD & negative exercise test result (age- / sex- / body mass index- matched).

Recruitment start date

02/09/2002

Recruitment end date

10/09/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Echocardiology Department
London
W12 0HS
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

Government

Funder name

Hammersmith Hospital 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

2006 meeting proceedings:
Raisakis K, Monaco C, Stamatelopoulos K, Desforges L, Liodakis E, Nihoyannopoulos P. Cytokines for myocardial ischemia: an echocardiography study European Society of Cardiology and World's Heart Federation Congress 2006, abstr. 3258.

Publication citations

Additional files

Editorial Notes