Coronary Artery Disease MedDRA version: 19.0 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders
Conditions
Sponsors
University Hospitals of North Midlands NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part A: Patient-participants will be eligible for the study if they are; • > 18 years of age • Patient-participant that have undergone a coronary artery CTCA calcium score as part of clinical care Part B: Patient-participants will be eligible for the study if they are; • > 18 years of age • CTCA score of >101 • Statin niave or receiving a statin other than atorvastatin, or atorvastatin =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Part A and B: Patient-participants will be excluded if they are unable to; 1. Give informed consent 2. Attend follow up clinic Excluded if they have a prior history of: • • Chronic renal failure (eGFR <30). • Significant hepatic disease(3x upper limit of normal liver profile). • Prior coronary artery bypass graft surgery, as these patients will have a high calcium score in native coronary arteries Part B: Unable to give informed consent Unable to attend follow up clinic Contraindications to statin therapy as per clinical judgement Excluded if they have a prior history of: • Adverse reaction to statin therapy • Chronic renal failure (eGFR <30 (based on recent clinical care sample within 2 months prior)). • Significant hepatic disease (3x upper limit of normal liver profile(based on recent clinical care sample within 2 months prior)).• Prior coronary artery bypass graft surgery, as these patients will have a high calcium score in native coronary arteries 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 Women who are breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are to firstly to assess a possible link between EPC count and CTCA calcium score. Secondly to identify if any difference in EPC count by either modest or high dose atorvastatin in coronary artery disease patients with a CTCA calcium score of 100-400 Agatston Units and >400 Agatston Units respectively.;Secondary Objective: Firstly, the results of the pilot study will allow presentation of abstract(s) at both national and international meetings if accepted. Secondly to establish whether a fully- powered controlled trial is feasible and therefore provide information to establish the likely staffing resources and timetable needed for a fully-powered controlled trial.; Primary end point(s): The outcome measure in Study A; To assess if there is a correlation between EPC count and Calcium scores. The outcome measure in Study B; Quantification of EPC response to moderate or high dose atorvastatin therapy in patient-participants with moderate to high calcium scores on CTCA. Study A EPC counts in relation to CTCA calcium scoring | — |
Countries
United Kingdom
Contacts
Public ContactDr Darren Clement, R&D Manager
University Hospitals of North Midlands NHS Trust
Outcome results
None listed