The relationship between CTCA and EPC Count

Phase 1

• Conditions: Coronary Artery Disease; MedDRA version: 19.0 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-005752-10-GB
• Lead Sponsor: niversity Hospitals of North Midlands NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-08
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 70

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 <80mg/day

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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified