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

NCT ID: NCT00783042

Last Updated: 2009-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atherosclerosis Inflammatory Activity in Coronary Arteries

Keywords

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TTDE-CFR coronary artery function cardiovascular biomarkers rosuvastatin Crestor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

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

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Rosuvastatin

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Crestor

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Björn Fagerberg, MD, Professor

Role: PRINCIPAL_INVESTIGATOR

Wallenberg LaboratorySahlgrenska University Hospital, S-413 45 Göteborg

Maria Leonsson-Zachrissson, MD

Role: STUDY_CHAIR

AstraZeneca R&D Mölndal

Locations

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Research Site

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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D1840M00006

Identifier Type: -

Identifier Source: org_study_id