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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: October 30, 2008
Last updated: June 29, 2009
Last verified: June 2009
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.

Condition Intervention Phase
Atherosclerosis Inflammatory Activity in Coronary Arteries Drug: Rosuvastatin Drug: Placebo Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in CFR peak velocity within rosuvastatin group after 1 month of treatment compared to baseline [ Time Frame: Baseline and after 1 month of treatment ]
  • Comparison of treatment effects on CFR peak velocities between groups after 1 month of treatment [ Time Frame: Baseline and after 1 month of treatment ]

Secondary Outcome Measures:
  • Changes in CFR peak velocity within the rosuvastatin group after 3 months compared to baseline and to 1 month [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline and after 1 month of treatment ]

Estimated Enrollment: 80
Study Start Date: October 2008
Study Completion Date: May 2009
Arms Assigned Interventions
Active Comparator: 1 Drug: Rosuvastatin
40 mg, tablet, oral, once daily for 1 (double blind) +2 months (open).
Other Name: Crestor
Placebo Comparator: 2 Drug: Placebo
Tablet, oral, once daily for 1 month (double blind)


Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00783042

Research Site
Goteborg, Sweden
Sponsors and Collaborators
Principal Investigator: Björn Fagerberg, MD, Professor Wallenberg LaboratorySahlgrenska University Hospital, S-413 45 Göteborg
Study Chair: Maria Leonsson-Zachrissson, MD AstraZeneca R&D Mölndal
  More Information

Responsible Party: Björn Carlsson MD, PhD, Medical Science Director, Clinical Discovery Team CV/GI, AstraZeneca Pharmaceuticals Identifier: NCT00783042     History of Changes
Other Study ID Numbers: D1840M00006
Study First Received: October 30, 2008
Last Updated: June 29, 2009

Keywords provided by AstraZeneca:
coronary artery function
cardiovascular biomarkers

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents processed this record on September 21, 2017