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Adverse Plaque Characteristics in CCTA and TVC Imaging (CITRUS)

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ClinicalTrials.gov Identifier: NCT02350959
Recruitment Status : Unknown
Verified October 2015 by Sanghoon Shin, National Health Insurance Service Ilsan Hospital.
Recruitment status was:  Recruiting
First Posted : January 30, 2015
Last Update Posted : October 7, 2015
Sponsor:
Information provided by (Responsible Party):
Sanghoon Shin, National Health Insurance Service Ilsan Hospital

Brief Summary:
The present study is intended to assess the vulnerability of plaques seen on CCTA by means of TVC Imaging System and to make comparisons between plaques with adverse plaque characteristics and ones without adverse plaque characteristics in terms of plaque volume and lipid core contents.

Condition or disease Intervention/treatment Phase
Plaque Drug: Atorvastatin Phase 4

Detailed Description:

This study is to be conducted in two phases - Phases 1 and 2. In Phase 1, the vulnerability of plaques seen on CCTA will be assessed with TVC Imaging System, and the plaque volume and lipid core contents of plaques with versus without adverse plaque characteristics will be compared. For the purpose of this study, the study of this phase will be a cross-sectional study in which the shapes of vulnerable plaques seen on CCTA will be compared to their vulnerability visualized by the TVC Imaging System.

In Phase 2, the patients with multi-vessel (polyvascular) disease of those participating in Phase 1 will be included, and the study of this phase will be a longitudinal study in which serial TVC imaging will be performed for non-target vessels, and any differences in changes of plaque vulnerability when treated with moderate-dose versus high-dose statin will be comparatively analyzed. The purpose of the present study is to determine whether there are any significant differences in changes of plaque volume and stability when treated with high-dose versus moderate-dose statin.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Adverse Plaque Characteristics in Coronary Computed Tomography Angiography Using Combined Near Infrared Spectroscopy With Intravascular Ultrasound [CITRUS Study]
Study Start Date : January 2015
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High dose statin
In high dose statin group, atorvastatin 40mg will be used
Drug: Atorvastatin
in high dose statin group, atorvastatin 40mg will be used and maintained until follow up angiography

Active Comparator: Moderate dose statin
in moderate dose statin group, atorvastatin 10mg will be used
Drug: Atorvastatin
in moderate dosea statin group, atorvastatin 10mg will be used and maintained until follow up angiography




Primary Outcome Measures :
  1. the change of max LCBI(4mm): Lipid core burden index in 4 mm [ Time Frame: 1 year ]
    The primary endpoint for this study is the change of max LCBI(4mm) between initial and follow up angiography in non-target vessel

  2. Correlation between vulnerable plaque on CT and max LCBI(4mm) [ Time Frame: maximum duration of 3 months between CT and NIRS ]
    The other primary endpoint of this study is Vessel level correlation of vulnerable plaque on CT and LCBI(4mm)


Secondary Outcome Measures :
  1. the change of presence of maxLCBI(4mm) > 500 [ Time Frame: 1 year ]
    vessel level comparison between initial and follow up angiography in non-target vessel

  2. the change of CT plaque vulnerability [ Time Frame: 2years ]
    the change of Positive remodeling, Low attenuation plaque, Spotty calcification



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 20 years of older
  2. Patients with typical chest pain or evidences of myocardial ischemia (e.g., stable, unstable angina, silent ischemia and positive functional study or reversible changes in the electrocardiogram (ECG) consistent with ischemia
  3. Patients with signed informed consent
  4. Confirmed coronary artery disease in computed tomography

Exclusion Criteria:

  1. The past history of coronary artery disease (e.g., myocardial infarction, percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), etc.)
  2. Less than 2-year life expectancy due to non-cardiac disease
  3. If the subject cannot voluntarily agree in writing to participate in this study
  4. If the subject is currently participating in any other study with another investigational drug or medical device
  5. Allergic reaction to iodinated contrast media
  6. Significant renal dysfunction (Serum creatinine > 1.5 mg/dl) 7 Heart rate ≥ 80 beats per minute even after treatment with a heart rate lowering medication which disable to take CCTA

8. Contraindications of either β blockers or nitroglycerin 9. The past history of complex congenital heart disease 10. Pregnant women or women with potential childbearing 11. Body mass index (BMI) exceeding 35 12. Irregular heartbeats which disable to take CCTA 13. Contraindications of statin due to hypersensitivity, past history of serious complication such as myopathy or increased liver enzyme more than 3 times of normal upper limit


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): NCT02350959


Contacts
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Contact: Sanghoon Shin, M.D. 82-10-8961-0707 nephilla99@gmail.com

Locations
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Korea, Republic of
National Health Insurance Service Ilsan Hospital Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of
Contact: Kyung-Jin Park    82-10-2442-4029      
Sponsors and Collaborators
National Health Insurance Service Ilsan Hospital
Investigators
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Principal Investigator: Sanghoon Shin, M.D. National Health Insurance Service Ilsan Hospital

Publications:

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Responsible Party: Sanghoon Shin, Director, Clinical Research, National Health Insurance Service Ilsan Hospital
ClinicalTrials.gov Identifier: NCT02350959     History of Changes
Other Study ID Numbers: 2014-11-022
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015
Keywords provided by Sanghoon Shin, National Health Insurance Service Ilsan Hospital:
Plaque
coronary computed tomography angiography
Additional relevant MeSH terms:
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Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors