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

Atherosclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00783042
• Other study ID #: D1840M00006
• Status: Completed
• Phase: Phase 0
• First received: October 30, 2008
• Last updated: June 29, 2009
• Start date: October 2008
• Est. completion date: May 2009

Study information

• Verified date: June 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Atherosclerosis
• Inflammatory Activity in Coronary Arteries

Intervention

Drug:
• Rosuvastatin
40 mg, tablet, oral, once daily for 1 (double blind) +2 months (open).
• Placebo
Tablet, oral, once daily for 1 month (double blind)

Locations

Country	Name	City	State
Sweden	Research Site	Goteborg

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CFR peak velocity within rosuvastatin group after 1 month of treatment compared to baseline		Baseline and after 1 month of treatment	No
Primary	Comparison of treatment effects on CFR peak velocities between groups after 1 month of treatment		Baseline and after 1 month of treatment	No
Secondary	Changes in CFR peak velocity within the rosuvastatin group after 3 months compared to baseline and to 1 month		Bseline, after 1 month and after 3 months of treatment	No
Secondary	Changes in other CFR parameters after one month rosuvastatin or placebo treatment; comparisons within groups and between groups		Baseline and after 1 month of treatment	No
Secondary	Changes in plasma lipids, lipoproteins and other cardiovascular biomarkers after 1 month of treatment with rosuvastatin or placebo; comparisons within groups and between groups		Baseline and after 1 month of treatment	No