Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr A Abraheem


Contact details

Department of Cardiology
City General Hospital
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

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 hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Cardiovascular: Acute myocardial infarction


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



Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. History of recent acute myocardial infarction (within the last 2 weeks)
2. Age 18-80
3. Able to give written consent

Participant type


Age group




Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

City General Hospital
United Kingdom

Sponsor information


Department of Health

Sponsor details

Richmond House
79 Whitehall
United Kingdom
+44 (0)20 7307 2622

Sponsor type




Funder type


Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Publication citations

Additional files

Editorial Notes