Clinical trial NCT00783042: Exploratory Study of Coronary Flow Reserve Measurements, a Non-Invasive Method for Coronary Function Measurements
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Atherosclerosis
Inflammatory Activity in Coronary Arteries
Keywords: TTDE-CFR
coronary artery function
cardiovascular biomarkers
rosuvastatin
Crestor
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 80
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in CFR peak velocity within rosuvastatin group after 1 month of treatment compared to baseline
timeFrame: Baseline and after 1 month of treatment
measure: Comparison of treatment effects on CFR peak velocities between groups after 1 month of treatment
timeFrame: Baseline and after 1 month of treatment
Secondary outcomes:
measure: Changes in CFR peak velocity within the rosuvastatin group after 3 months compared to baseline and to 1 month
timeFrame: Bseline, after 1 month and after 3 months of treatment
measure: Changes in other CFR parameters after one month rosuvastatin or placebo treatment; comparisons within groups and between groups
timeFrame: Baseline and after 1 month of treatment
measure: Changes in plasma lipids, lipoproteins and other cardiovascular biomarkers after 1 month of treatment with rosuvastatin or placebo; comparisons within groups and between groups
timeFrame: Baseline and after 1 month of treatment
Other outcomes:
Locations:
city: Goteborg
country: Sweden
facility: Research Site
Study officials:
affiliation: Wallenberg LaboratorySahlgrenska University Hospital, S-413 45 Göteborg
name: Björn Fagerberg, MD, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D Mölndal
name: Maria Leonsson-Zachrissson, MD
role: STUDY_CHAIR
References: