Acute Coronary Syndrome Clinical Trial
Official title:
The Effect on Endothelial Progenitor Cells (EPCs) by Statin Loading in "All Comers" With an Acute Coronary Syndrome (ACS)
Cardiovascular disease is a major cause of morbidity and mortality worldwide. There are a
number of risk factors for coronary artery disease and all to often patients admitted with an
acute coronary syndrome have these comorbidities.
The main stay of treatment of such patients is to perform coronary angiography and if
required coronary angioplasty.
Previous studies have shown a link between endothelial progenitor cell (EPC) count, coronary
artery disease and statin therapy or loading, however these studies have excluded patients
with significant comorbidities and therefore have not truly represented "real life" patients.
This pilot study will assess EPC response in patients that are able to undergo coronary
intervention as part of their normal clinical management under current guidelines regardless
of pre-existing comorbidities. The research team believe this will allow representation of
"real world" patients.
This pilot study will include up to 40 patient-participants admitted into the coronary care
unit of the Royal Stoke University Hospital a large and busy tertiary cardiac centre.
Patient-participants will be assessed, and if deemed appropriate to undergo coronary
angiography and or angioplasty will be eligible for enrolment in the study.
Following standard care angiogram / angioplasty, patient-participants will be given a minimum
of 3 hours to consent to ensure that there is no delay in clinical treatment. A short
information sheet will be given to the patient initially. If the patient is interested in the
study, the full participant information sheet will be given. If potential
patient-participants consent to study participation 3-5ml of blood will be venesected and
sent for EPC analysis. That late evening atorvastatin 80mg will be given as per current
national recommendations. Patient-participants will then have venesection for EPC analysis on
days 1-2, 3-4 and finally 7-8. ACS patients are usually in hospital for 3 or 4 days provided
there are no complications. It is therefore anticipated that days 0, 1-2 and 3-4 venesections
may be performed whilst patient-participants are within the cardiology department. However an
outpatient cardiology research clinic follow up will be arranged for day 7-8 to allow the
final venesection for EPC analysis.
This pilot study will assess EPC response in patients that are able to undergo coronary
intervention as part of their normal clinical management under current guidelines regardless
of pre-existing comorbidities. The research team believe this will allow representation of
"real world" patients.
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