Condition category
Circulatory System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
20/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A Abraheem

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0158141878

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

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

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

Phase

Drug names

Primary outcome measures

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

01/05/2003

Overall trial end date

01/05/2005

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/2003

Recruitment end date

01/05/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

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

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes