Imaging of Atherosclerosis With 68Ga-MSA

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health & Welfare, Korea
Information provided by (Responsible Party):
Hong Seog Seo, Korea University
ClinicalTrials.gov Identifier:
NCT01889693
First received: June 26, 2013
Last updated: August 23, 2013
Last verified: August 2013
  Purpose

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
Atherosclerosis
Noninvasive Imaging of Atherosclerosis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Korea University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • side effect of PET imaging with 68Ga-MSA [ Time Frame: with 7 days after PET imaging ] [ Designated as safety issue: Yes ]
    any side effects including changes of biochemical values and vital signs


Enrollment: 60
Study Start Date: August 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
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

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01889693

Locations
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

No publications provided

Responsible Party: Hong Seog Seo, Professor of Medicine, Korea University
ClinicalTrials.gov Identifier: NCT01889693     History of Changes
Other Study ID Numbers: GaMSA-Atherosclerosis
Study First Received: June 26, 2013
Last Updated: August 23, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korea University:
positron emission tomography
macrophage
neomannosyl human serum albumin

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014