We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00783042
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : June 30, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Atherosclerosis Inflammatory Activity in Coronary Arteries Drug: Rosuvastatin Drug: Placebo Early Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Study Start Date : October 2008
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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 :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00783042


Locations
Sweden
Research Site
Goteborg, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
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
ClinicalTrials.gov Identifier: NCT00783042     History of Changes
Other Study ID Numbers: D1840M00006
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: June 30, 2009
Last Verified: June 2009

Keywords provided by AstraZeneca:
TTDE-CFR
coronary artery function
cardiovascular biomarkers
rosuvastatin
Crestor

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors