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

Early Phase 1

Completed

• Conditions: Atherosclerosis; Inflammatory Activity in Coronary Arteries
• Interventions: Drug: Placebo; Drug: Rosuvastatin

• Registration Number: NCT00783042
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-30
• Study First Submitted QC: 2008-10-30
• Study First Posted: 2008-10-31
• Study Completion: 2009-05
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-29
• Last Update Posted: 2009-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Rosuvastatin	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇸🇪 Goteborg, Sweden