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
The effect of myocardial ischaemia on pro-inflammatory cytokines and stress proteins: a randomised controlled study
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
Hospitals
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 Applicable
Drug names
Dobutamine
Primary outcome measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
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.