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
Secondary identifying numbers	N0158141878

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

Department of Cardiology
City General Hospital
Stoke-on-Trent
ST4 6QG
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	1. Level of IL6/CRP at pre discharge, 1st and last attendance to the gym, 3 & 6 month post myocardial infarction 2. Level of E-selectin at pre discharge, 1st and last attendance to the gym, 3 & 6 month post myocardial infarction 3. Level of TF at pre discharge, 1st and last attendance to the gym, 3 & 6 month post myocardial infarction
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/05/2003
Completion date	01/05/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	80 Years
Sex	Both
Target number of participants	Not provided at time of registration
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

England
United Kingdom

Study participating centre

City General Hospital

Stoke-on-Trent
ST4 6QG
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

North Staffordshire Research and Development Consortium - North Staffordshire Hospital Trust (UK), NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan