Imaging of Atherosclerosis With 68Ga-MSA

August 23, 2013 updated by: Hong Seog Seo, Korea University

Identification of Vascular Inflammatory Image Using a 68Ga-MSA(Gallium-68 Neomannosyl Human Serum Albumin) in Patients With Atherosclerotic Lesions

Despite of intensive efforts, no specific ath¬erosclerosis-targeting agent labeled with positron emitter is not yet available. Fortunately, some scientists made the major advance in the field of clinical atherosclerosis molecular imaging by the metabolic PET reporter agent 18F(fluorine-18)-FDG(Fludeoxyglucose) applied to noninvasively image plaque macrophages in carotid arteries. However, coronary and cerebral arterial segments remain uninterpretable due to metabolic property of 18F-FDG. Applying the character of the terminal mannose residues of MSA binding with the mannose receptors of macrophages in atherosclerosis, we investigate whether 68Ga-MSA can be a novel agent for non-invasive molecular imaging of atherosclerotic lesion in PET.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

20 patients with acute coronary syndrome, 20 patients with chronic stable angina and 20 control subjects wihout coronary artery disease of the Cardiovascular Center at Korea University Guro Hospital

Description

Inclusion Criteria:

  • acute coronary syndrome(acute myocardial infarction, unstable angina)
  • chronic stable angina
  • control without coronary artery disease

Exclusion Criteria:

  • pregnancy, allergy to albumin, chronic inflammatory disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
acute coronary syndrome
patients with acute myocardial infarction and unstable angina
chronic stable angina
patients with chronic stable angina
control
control subjects without coronary artery disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
comparison of SUV(standard uptake unit) at atherosclerotic plaque of aorta and carotid arteries among 3 groups
Time Frame: 1 day at the time of PET(positron emission tomogram) imaging
1 day at the time of PET(positron emission tomogram) imaging

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
side effect of PET imaging with 68Ga-MSA
Time Frame: with 7 days after PET imaging
any side effects including changes of biochemical values and vital signs
with 7 days after PET imaging

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University

Collaborators

Ministry of Health & Welfare, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

June 26, 2013

First Submitted That Met QC Criteria

June 27, 2013

First Posted (Estimate)

June 28, 2013

Study Record Updates

Last Update Posted (Estimate)

August 27, 2013

Last Update Submitted That Met QC Criteria

August 23, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GaMSA-Atherosclerosis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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