Exploratory Study of Coronary Flow Reserve Measurements, a Non-Invasive Method for Coronary Function Measurements

Study Overview
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Brief Summary
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The aim of this study is to investigate whether the non-invasive ultrasound method for assessment of coronary blood flow, transthoracic Doppler echocardiography-coronary flow reserve (TTDE-CFR), can be used to measure drug effects.

Official Title
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A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Transthoracic Doppler Echocardiography Method as a Non-Invasive Method for Coronary Function Measurements; Ability to Detect Short-Term Statin Effects in Patients With Increased Cardiovascular Risk

Conditions
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Atherosclerosis, Inflammatory Activity in Coronary Arteries

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males aged 45-75 years or females aged 60-75 years inclusive Carotid and/or femoral atherosclerotic plaque, as assessed by carotid ultrasound examination within the last 5 years Abnormal concentrations of lipids or lipoproteins in the blood Provision of signed informed consent Exclusion Criteria: Treatment with statins or other lipid-lowering drugs, e.g. fibrates, nicotinic acid, cholesterol absorption inhibitor, within the last 6 months before randomisation Current smoking or snuff tobacco use Major CV event (myocardial infarction (MI), stroke/ transitory ischemic attack (TIA), Acute Coronary Syndrome (ACS), revascularisation) within the last 6 months before randomisation Symptomatic carotid stenosis, atrioventricular (AV) block, QT-prolongation, atrial fibrillation, sinus node disease (such as sick sinus syndrome or symptomatic bradycardia), chronic obstructive pulmonary disease (COPD) or asthma

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Rosuvastatin<br>* 40 mg, tablet, oral, once daily for 1 (double blind) +2 months (open).<br>* Other names: Crestor;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Tablet, oral, once daily for 1 month (double blind)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CFR peak velocity within rosuvastatin group after 1 month of treatment compared to baseline |  | Baseline and after 1 month of treatment | 
| Comparison of treatment effects on CFR peak velocities between groups after 1 month of treatment |  | Baseline and after 1 month of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in CFR peak velocity within the rosuvastatin group after 3 months compared to baseline and to 1 month |  | Bseline, after 1 month and after 3 months of treatment | 
| Changes in other CFR parameters after one month rosuvastatin or placebo treatment; comparisons within groups and between groups |  | Baseline and after 1 month of treatment | 
| Changes in plasma lipids, lipoproteins and other cardiovascular biomarkers after 1 month of treatment with rosuvastatin or placebo; comparisons within groups and between groups |  | Baseline and after 1 month of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TTDE-CFR, coronary artery function, cardiovascular biomarkers, rosuvastatin, Crestor