1. New onset angina 2. Acute coronary syndromes (ACS) to include ST elevation ACS and None ST elevation ACS
Conditions
Sponsors
University Hospitals of North Midlands NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Participants aged between 18 and 75 years with new onset angina or • Participants aged between 18 and 75 years with Acute Coronary Syndrome (ACS) diagnosed by a positive blood test called troponin that suggests a cardiac event • Participants with new onset angina may be statin naïve • Participants with ACS can either be stating naïve or reloaded with atorvastatin 80 mg • All participants must have the ability to give informed consent • All patients able to attend follow up visits Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: The exclusion criteria can be sub-divided into 5 categories; Clinical • Unstable Angina as per clinical assessment / judgement • Diabetes mellitus type I or II • Stable angina group should be statin naive • All participants must have no other significant comorbidity for example malignancy on or off therapy, chronic obstructive pulmonary disease on home oxygen or nebuliser therapy, inflammatory bowel disease, on going steroid therapy, autoimmune disease, therapy with disease modifying medications for rheumatic or autoimmune disease. • Women who are pregnant or breastfeeding • Allergies to excipients of IMP • Women of child bearing potential unless they are using a recognised effective form of contraception or are not sexually active, and have no intention of becoming sexually active during the course of the trial. Previous adverse reaction or contra-indications • Any contraindication(s) to statin therapy • Any prior adverse reaction(s) to any statin therapy Biochemical • Total cholesterol greater than 7.5 mmol/L • Liver function tests deranged from normal range • eGFR less than 90 ml/min/1.73m2 Haematological • Concurrent haematological conditions requiring active drug or chemotherapy Follow up • Inability to attend follow up appointments Other • Current or planned participation in another drug trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To establish whether a fully- powered controlled trial is feasible. • To establish the likely staffing resources and timetable needed for a fully-powered controlled trial. ;Timepoint(s) of evaluation of this end point: 1 month; Main Objective: This initial proof of concept pilot study will firstly confirm that our current flow cytometric assays allow identification and quantification of endothelial progenitor cells (EPCs) in patients with cardiovascular disease on statin therapy. Secondly to assess time and temperature stability of our samples. • Develop expertise with cardiology and haematology for whole blood flow cytometric assay for EPCs, in particular the stability of samples both at room temperature and 40 C • Sample Stability overtime • To Identify the time course of EPC mobilisation • Identify any obvious differences between acute coronary syndrome patients and stable ischaemic heart disease/new onset angina patients. ; Primary end point(s): Primary objective • Develop expertise with cardiology and haematology for whole blood flow cytometric assay for EPCs, in particular the stability of samples both at room temperature and 40 C • Sample Stability overtime • To Identify the time course of EPC mobilisation • Identify any obvious differences between acute coronary syndrome patients and stable ischaemic heart disease/new onset angina patients. To summarise this pilot study will allow the following; • Develop expertise with cardiology and haematology for whole blood flow cytometric assay for EPCs. • To identify the time course of EPC mobilisation. • Assess time and temperature stability of samples. • To identifying any obvious differences between acute corona | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1 month; Secondary end point(s): • To establish whether a fully- powered controlled trial is feasible. • To establish the likely staffing resources and timetable needed for a fully-powered controlled trial. | — |
Countries
United Kingdom
Contacts
Public ContactDr Darren Clement
University Hospitals of North Midlands NHS Trust
Outcome results
None listed