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

Primary Purpose

Atherosclerosis, Inflammatory Activity in Coronary Arteries

Status

Completed

Phase

Early Phase 1

Locations

Sweden

Study Type

Interventional

Intervention

Rosuvastatin

Placebo

About this trial

This is an interventional basic science trial for Atherosclerosis focused on measuring TTDE-CFR, coronary artery function, cardiovascular biomarkers, rosuvastatin, Crestor

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Change in CFR peak velocity within rosuvastatin group after 1 month of treatment compared to baseline

Comparison of treatment effects on CFR peak velocities between groups after 1 month of treatment

Secondary Outcome Measures

Changes in CFR peak velocity within the rosuvastatin group after 3 months compared to baseline and to 1 month

Changes in other CFR parameters after one month rosuvastatin or placebo treatment; comparisons within groups and between groups

Changes in plasma lipids, lipoproteins and other cardiovascular biomarkers after 1 month of treatment with rosuvastatin or placebo; comparisons within groups and between groups

Full Information

NCT ID

NCT00783042

First Posted

October 30, 2008

Last Updated

June 29, 2009

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00783042

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerosis, Inflammatory Activity in Coronary Arteries

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin

Other Intervention Name(s)

Crestor

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Title

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 Outcome Measure Information:

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Björn Fagerberg, MD, Professor

Organizational Affiliation

Wallenberg LaboratorySahlgrenska University Hospital, S-413 45 Göteborg

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Maria Leonsson-Zachrissson, MD

Organizational Affiliation

AstraZeneca R&D Mölndal

Official's Role

Study Chair

Facility Information:

Facility Name

Research Site

City

Goteborg

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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