Adverse Plaque Characteristics in CCTA and TVC Imaging (CITRUS)

October 5, 2015 updated by: Sanghoon Shin, National Health Insurance Service Ilsan Hospital

Evaluation of Adverse Plaque Characteristics in Coronary Computed Tomography Angiography Using Combined Near Infrared Spectroscopy With Intravascular Ultrasound [CITRUS Study]

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

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

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of
        • Recruiting
        • National Health Insurance Service Ilsan Hospital
        • Contact:
          • Kyung-Jin Park
          • Phone Number: 82-10-2442-4029

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High dose statin
In high dose statin group, atorvastatin 40mg will be used
Drug: Atorvastatin
in moderate dosea statin group, atorvastatin 10mg will be used and maintained until follow up angiography
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
Drug: Atorvastatin
in high dose statin group, atorvastatin 40mg will be used and maintained until follow up angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
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)
maximum duration of 3 months between CT and NIRS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
the change of CT plaque vulnerability
Time Frame: 2years
the change of Positive remodeling, Low attenuation plaque, Spotty calcification
2years

Collaborators and Investigators

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

Sponsor

National Health Insurance Service Ilsan Hospital

Investigators

  • Principal Investigator: Sanghoon Shin, M.D., National Health Insurance Service Ilsan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2015

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

January 16, 2015

First Submitted That Met QC Criteria

January 29, 2015

First Posted (Estimate)

January 30, 2015

Study Record Updates

Last Update Posted (Estimate)

October 7, 2015

Last Update Submitted That Met QC Criteria

October 5, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-11-022

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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