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

June 29, 2009 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Goteborg, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: Placebo
Tablet, oral, once daily for 1 month (double blind)
Active Comparator: 1
Drug: Rosuvastatin
40 mg, tablet, oral, once daily for 1 (double blind) +2 months (open).
Other Names:
  • Crestor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Baseline and after 1 month of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
Baseline and after 1 month of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

October 30, 2008

First Submitted That Met QC Criteria

October 30, 2008

First Posted (Estimate)

October 31, 2008

Study Record Updates

Last Update Posted (Estimate)

June 30, 2009

Last Update Submitted That Met QC Criteria

June 29, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1840M00006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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