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Imaging of Atherosclerosis With 68Ga-MSA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01889693
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : August 27, 2013
Sponsor:
Collaborator:
Ministry of Health & Welfare, Korea
Information provided by (Responsible Party):
Hong Seog Seo, Korea University

Study Description
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Brief Summary:
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.

Condition or disease
Atherosclerosis Noninvasive Imaging of Atherosclerosis

Study Design
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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Identification of Vascular Inflammatory Image Using a 68Ga-MSA(Gallium-68 Neomannosyl Human Serum Albumin) in Patients With Atherosclerotic Lesions
Study Start Date : August 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889693


Locations
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Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of, 152-703
Sponsors and Collaborators
Korea University
Ministry of Health & Welfare, Korea
More Information
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Responsible Party: Hong Seog Seo, Professor of Medicine, Korea University
ClinicalTrials.gov Identifier: NCT01889693    
Other Study ID Numbers: GaMSA-Atherosclerosis
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: August 27, 2013
Last Verified: August 2013
Keywords provided by Hong Seog Seo, Korea University:
positron emission tomography
macrophage
neomannosyl human serum albumin
Additional relevant MeSH terms:
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Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases