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

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00783042

Enrollment

Registered

2008-10-31

Start date

2008-10-31

Completion date

2009-05-31

Last updated

2009-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Inflammatory Activity in Coronary Arteries

Keywords

TTDE-CFR, coronary artery function, cardiovascular biomarkers, rosuvastatin, Crestor

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.

Interventions

DRUGRosuvastatin

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in CFR peak velocity within rosuvastatin group after 1 month of treatment compared to baseline	Baseline and after 1 month of treatment
Comparison of treatment effects on CFR peak velocities between groups after 1 month of treatment	Baseline and after 1 month of treatment

Secondary

Measure	Time frame
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
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
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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026