The effect of myocardial ischaemia on pro-inflammatory cytokines and stress proteins

ISRCTN ISRCTN34742708
DOI https://doi.org/10.1186/ISRCTN34742708
Secondary identifying numbers N0016121116
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
09/08/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
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

Contact information

Prof Petros Nihoyannopoulos
Scientific

Echocardiology Department
Cardiology
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Phone +44 020 8383 3948
Email petros@imperial.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe effect of myocardial ischaemia on pro-inflammatory cytokines and stress proteins: a randomised controlled study
Study objectivesAre the cytokines elevated during stress?
Ethics approval(s)Added 24 July 2008:
Approval granted by Hammersmith, Queen Charlotte's & Chelsea and Acton Hospital Research Ethics Committee.
Health condition(s) or problem(s) studiedCardiovascular: Myocardial ischaemia
InterventionTreadmill Stress vs Pharmacological Stress (Dobutamine)
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Dobutamine
Primary outcome measureTo 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 measuresNo secondary outcome measures
Overall study start date02/09/2002
Completion date10/09/2009

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants40
Key inclusion criteriaAdded 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)
Key exclusion criteriaAdded 24 July 2008:
Control subjects with low pre-exercise test probability of CAD & negative exercise test result (age- / sex- / body mass index- matched).
Date of first enrolment02/09/2002
Date of final enrolment10/09/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Echocardiology Department
London
W12 0HS
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Government

Hammersmith Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

09/08/2021: Internal review.
13/09/2017: Internal review.