Inflammatory and endothelial markers in heart disease: relation to tissue factor TF - effect of early controlled exercises post acute myocardial infarction on IL6, E-selectin, and TF
| ISRCTN | ISRCTN87431833 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87431833 |
| Protocol serial number | N0158141878 |
| Sponsor | Department of Health |
| Funder | North Staffordshire Research and Development Consortium - North Staffordshire Hospital Trust (UK), NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 20/08/2015
- 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
Dr A Abraheem
Scientific
Scientific
Department of Cardiology
City General Hospital
Stoke-on-Trent
ST4 6QG
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Inflammatory and endothelial markers in heart disease: relation to tissue factor TF - effect of early controlled exercises post acute myocardial infarction on IL6, E-selectin, and TF |
| Study objectives | 1. Patients who start high level controlled exercise post acute myocardial infarction (AMI) have lower research indices (IL6, TF, E-selectin) in comparison to those who start low level controlled exercise at the time of their discharge from rehab and at 3 & 6 month post AMI. 2. Patients who perform early controlled exercises post AMI have lower research indices in comparison to late controlled exercise at 3 & 6 month post AMI? 3. Patients with lower levels of research indices at the end of their rehab, 3 & 6 will have better outcome at 1 year. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Acute myocardial infarction |
| Intervention | 1. Usually Patients who are admitted to CCU/Medical wards with acute myocardial infarction are approached by cardiac rehabilitation nurses to invite them to our cardiac rehabilitation program. Patients information sheet concerning this study will be given to all patient, and later on (pre-discharge from hospital) will be visited by the research Doctor for further discussion, if they are happy to participate in this study a written informed consent will be obtained, and basic clinical information will be recorded on a standard Performa: this will include: Demography, height, weight, BMI, medication, risk factors (smoking status, diabetes, hypercholestraemia, family history, hypertension), any relevant past medical history (MI, CVA, TIA¿etc) will be recorded. 2. Patients undertaking this study will have their blood tested prior discharge from hospital (T0) for the research markers. 3. Patient will do their exercise test within day (5-14) post acute myocardial infarction, and according to their ETT results will divided into 4 groups: Patient who are unable to exercise for any reason will act as a control group. All eligible patients will have Modified Bruce Protocol within 5-14 days post acute myocardial infarction. Patient who have negative exercise test for inducible myocardial ischaemia at moderate/high work load(>7 METS), will be randomised using the above mentioned method. Into 4 groups: i) Early rehab with high work load exercises. ii) Late rehab with high work load exercises. iii) Early rehab with low work load exercises. vi) Late rehab with low work load exercises. Blood samples will be collected on attendance for ETT, pre (T1) and post (T2) 4. In addition to our assessment of the above-mentioned marker all groups will be followed for 12 months in term of: - Mortality (cardiovascular death) - Morbidity (MI, unstable angina, unstable coronary syndrome, LV failure, re-vascularisation). Blood samples will be obtained through this sheath (15 mls) will be spun at 3000 rp/m for 15 minutes, and the citrated plasma obtained will be divided into four aliquots, and will be stored at (-40 to -80 o C) and will later be transferred to the Haemostasis Thrombosis and Vascular unit, University of Birmingham for batched analyses by in house ELISA (IL6, Tf, E-selectin). |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Level of IL6/CRP at pre discharge, 1st and last attendance to the gym, 3 & 6 month post myocardial infarction |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Key inclusion criteria | 1. History of recent acute myocardial infarction (within the last 2 weeks) 2. Age 18-80 3. Able to give written consent |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/05/2003 |
| Date of final enrolment | 01/05/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
City General Hospital
Stoke-on-Trent
ST4 6QG
United Kingdom
ST4 6QG
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 |
