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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

Tracking Information
First Submitted Date June 26, 2013
First Posted Date June 28, 2013
Last Update Posted Date August 27, 2013
Study Start Date August 2012
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 27, 2013)		 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 27, 2013)		 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Imaging of Atherosclerosis With 68Ga-MSA
Official Title Identification of Vascular Inflammatory Image Using a 68Ga-MSA(Gallium-68 Neomannosyl Human Serum Albumin) in Patients With Atherosclerotic Lesions
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Atherosclerosis
  • Noninvasive Imaging of Atherosclerosis
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 27, 2013)		 60
Original Estimated Enrollment Same as current
Actual Study Completion Date August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01889693
Other Study ID Numbers GaMSA-Atherosclerosis
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Hong Seog Seo, Korea University
Original Responsible Party Same as current
Current Study Sponsor Korea University
Original Study Sponsor Same as current
Collaborators Ministry of Health & Welfare, Korea
Investigators Not Provided
PRS Account Korea University
Verification Date August 2013