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OpenTrials
Completed

NCT Number: NCT00783042

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

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Inflammatory Activity in Coronary Arteries Vascular Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Research Site

Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

40 mg, tablet, oral, once daily for 1 (double blind) +2 months (open).

Other names: Crestor

Placebo

Drug

Tablet, oral, once daily for 1 month (double blind)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Study completion
2009
First posted
Oct 31, 2008
Registry last updated
Jun 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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