The effect of myocardial ischaemia on pro-inflammatory cytokines and stress proteins
| ISRCTN | ISRCTN34742708 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34742708 |
| Protocol serial number | N0016121116 |
| Sponsor | Department of Health (UK) |
| Funder | Hammersmith Hospital NHS Trust (UK) |
- 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
Scientific
Echocardiology Department
Cardiology
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
| Phone | +44 020 8383 3948 |
|---|---|
| petros@imperial.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The effect of myocardial ischaemia on pro-inflammatory cytokines and stress proteins: a randomised controlled study |
| Study objectives | Are 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) studied | Cardiovascular: Myocardial ischaemia |
| Intervention | Treadmill Stress vs Pharmacological Stress (Dobutamine) |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Dobutamine |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 10/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 40 |
| Key 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) |
| Key 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). |
| Date of first enrolment | 02/09/2002 |
| Date of final enrolment | 10/09/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Echocardiology Department
London
W12 0HS
United Kingdom
W12 0HS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/08/2021: Internal review.
13/09/2017: Internal review.
