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OpenTrials
Completed

NCT Number: NCT00703261

Evaluate the Utility of 18FDG-PET as a Tool to Quantify Atherosclerotic Plaque (MK-0000-081 AM3)(COMPLETED)

The purpose of this study is to evaluate the utility of 18Fluorine Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET) as a tool to quantify atherosclerotic plaque.

Completed

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Key information

Conditions

Atherosclerotic Vascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or Female ages 30 to 80
  • Participant is on a low dose statin for at least 6 weeks prior to screening or is statin-naive at screening

Exclusion criteria

  • Participant has human immunodeficiency virus (HIV), Hepatitis B or C
  • Participant uses illegal drugs
  • Participant has Type I diabetes
  • Participant has a history of claustrophobia

Treatment and study plan

atorvastatin

Drug

Participants will be asked to self-administer one atorvastatin 10 mg or 80 mg tablet at approximately the same time each day.

Other names: Lipitor

Placebo

Drug

Participants will be asked to self-administer one tablet of placebo to atorvastatin 10 mg or 80 mg at approximately the same time each day.

Primary outcomes

  1. Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment

    Time frame: Baseline and Week 12

    Vascular plaque inflammation was measured by 18FDG-PET imaging. Uptake of FDG by the carotid and thoracic aorta is expressed as the target, vessel wall to background, lumen ratio (TBR). TBRmax of an axial cross section of a vessel (a slice) is defined as the maximum TBR within a slice and TBRmeanmax is the mean of TBRmax for all slices in the qualifying segment. The qualifying segment is the left or right carotid or thoracic aorta with the greatest FDG uptake value at Baseline.

Secondary outcomes

  1. Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment in Statin-naive Participants

    Time frame: Baseline and Week 12

    Vascular plaque inflammation was measured by 18FDG-PET imaging. Uptake of FDG by the carotid and thoracic aorta is expressed as the target, vessel wall to background, lumen ratio (TBR). TBRmax of an axial cross section of a vessel (a slice) is defined as the maximum TBR within a slice and TBRmeanmax is the mean of TBRmax for all slices in the qualifying segment. The qualifying segment is the left or right carotid or thoracic aorta with the greatest FDG uptake value at Baseline.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized, Double-Blind, Parallel Group Study to Evaluate the Effects of High Dose Statin Therapy on 18Fluorine Fluorodeoxyglucose (18FDG) Uptake in Arteries of Patients With Atherosclerotic Vascular Disease

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 23, 2008
Registry last updated
Oct 9, 2015

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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