The Effect on EPCs by Statin Loading in "All Comers" With an ACS
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Atorvastatin; Blood samples
Intervention type(s): Drug; Other
Intervention description(s): 3-5 mls of blood is taken at baseline and 3 subsequent timepoints and processed for Endothelial Progenitor Count (EPC).
Intervention MeSH terms: Atorvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention