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Evaluation of Statin-induced Lipid-rich Plaque Progression by Optical Coherence Tomography (OCT) Combined With Intravascular Ultrasound (IVUS)

Primary Purpose

Coronary Artery Disease, Hyperlipidemia

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Atorvastatin
Atorvastatin
Rosuvastatin
Sponsored by
Harbin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring optical coherence tomography, intravascular ultrasound, Coronary artery disease, Hyperlipidemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age :18-75Y
  2. Clinical indication for coronary angiography (CAG).
  3. CAG demonstrates at least 1 de novo lesion with luminal diameter stenosis between 20% and 70% (visual estimation).
  4. OCT demonstrates the lesion is a lipid-rich plaque (FCT ≤200μm and lipid arc ≥100o).
  5. LDL-C range between 70mg /dl and 160mg /dl.
  6. Patient or legal guardian understands and agrees to comply with all specified study requirements and provides written informed consent.

Exclusion criteria:

  1. Life expectancy <12 months due to another medical condition.
  2. Contraindication to the atorvastatin and rosuvastatin.
  3. Creatinine levels more than 2.0mg/dL or ESRD.
  4. Severe hepatic dysfunction (AST and/or ALT more than 3 times the upper limit of normal).
  5. Congestive heart failure (left ventricle eject fraction ≤35%).
  6. Female of childbearing potential with a positive pregnancy test within 7 days before study, or lactating, or intends to become pregnant during the following 12 months.
  7. The patient is likely to require coronary bypass surgery, cardiac transplantation, surgical repair or replacement during the course.

Exit criteria

  1. ALT/AST ≥ 3times upper limit of normal after enrollment.
  2. Muscle ache/myopathy.
  3. Lose follow-up.
  4. Patient insists on exit.

Sites / Locations

  • The Second Affiliated Hospital of Harbin Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Group A:

Group B:

Group C:

Arm Description

Atorvastatin 20mg

Atorvastatin 60mg

Rosuvastatin 10mg

Outcomes

Primary Outcome Measures

To compare the effects of atorvastatin 20mg and atorvastatin 60mg on the changes of FCT assessed by OCT and plaque burden by IVUS.

Secondary Outcome Measures

To investigate the changes of FCT assessed by OCT and plaque burden by IVUS in comparisons of atorvastatin 60 mg vs rosuvastatin 10 mg, and atorvastatin 20 mg vs rosuvastatin 10 mg.
To investigate the changes of remodeling index assessed by IVUS in comparisons of atorvastatin 60 mg vs atorvastatin 20 mg,atorvastatin 60 mg vs rosuvastatin 10 mg, and atorvastatin 20 mg vs rosuvastatin 10 mg
To investigate the changes of macrophage infiltration semi-quantitatively by OCT in comparisons of atorvastatin 60 mg vs atorvastatin 20 mg,atorvastatin 60 mg vs rosuvastatin 10 mg, and atorvastatin 20 mg vs rosuvastatin 10 mg

Full Information

First Posted
December 1, 2009
Last Updated
September 10, 2013
Sponsor
Harbin Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01023607
Brief Title
Evaluation of Statin-induced Lipid-rich Plaque Progression by Optical Coherence Tomography (OCT) Combined With Intravascular Ultrasound (IVUS)
Official Title
Evaluation of Statin-induced Lipid-rich Plaque Progression by Optical Coherence Tomography (OCT)Combined With Intravascular Ultrasound (IVUS)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harbin Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Many trials suggested that lipid lowering therapy could significantly reduce cardiovascular events. Enhancing stability of vulnerable plaque is probably the main reason by which statins reduce adverse coronary events. The size of lipid core and the fibrous cap thickness (FCT) are the major determinants of plaque vulnerability. So, it is very important to accurately evaluate changes in plaque after stains therapy. Previous reports suggested that intensive lipid lowering therapy provide more significantly clinical benefit compared with moderate lipid lowering therapy.Such benefit may contribute to the changes in following parameters: FCT, lipid arc(quadrants), TCFA, macrophage, plaque disruption, and thrombus measured by OCT, and plaque burden and remodeling index by IVUS. Current intravascular imaging modalities, such as optical coherence tomography (OCT) and intravascular ultrasound (IVUS) can provide in vivo quantitative and qualitative information of coronary plaques. However, there were few studies aimed at monitoring the progression of coronary plaques in patients receiving statin therapy by OCT combined with IVUS. Therefore, the study we designed were to compare the effect of the rosuvastatin 10mg, atorvastatin 20mg and atorvastatin 60mg treatment on the changes in FCT and lipid core arc by OCT and plaque burden by IVUS of coronary atherosclerotic plaques.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Hyperlipidemia
Keywords
optical coherence tomography, intravascular ultrasound, Coronary artery disease, Hyperlipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A:
Arm Type
Active Comparator
Arm Description
Atorvastatin 20mg
Arm Title
Group B:
Arm Type
Experimental
Arm Description
Atorvastatin 60mg
Arm Title
Group C:
Arm Type
Active Comparator
Arm Description
Rosuvastatin 10mg
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin 20mg/day
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin, 60mg/day
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
Rosuvastatin,10mg/day
Primary Outcome Measure Information:
Title
To compare the effects of atorvastatin 20mg and atorvastatin 60mg on the changes of FCT assessed by OCT and plaque burden by IVUS.
Time Frame
12 months after enrollment
Secondary Outcome Measure Information:
Title
To investigate the changes of FCT assessed by OCT and plaque burden by IVUS in comparisons of atorvastatin 60 mg vs rosuvastatin 10 mg, and atorvastatin 20 mg vs rosuvastatin 10 mg.
Time Frame
12 months
Title
To investigate the changes of remodeling index assessed by IVUS in comparisons of atorvastatin 60 mg vs atorvastatin 20 mg,atorvastatin 60 mg vs rosuvastatin 10 mg, and atorvastatin 20 mg vs rosuvastatin 10 mg
Time Frame
12 months
Title
To investigate the changes of macrophage infiltration semi-quantitatively by OCT in comparisons of atorvastatin 60 mg vs atorvastatin 20 mg,atorvastatin 60 mg vs rosuvastatin 10 mg, and atorvastatin 20 mg vs rosuvastatin 10 mg
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age :18-75Y Clinical indication for coronary angiography (CAG). CAG demonstrates at least 1 de novo lesion with luminal diameter stenosis between 20% and 70% (visual estimation). OCT demonstrates the lesion is a lipid-rich plaque (FCT ≤200μm and lipid arc ≥100o). LDL-C range between 70mg /dl and 160mg /dl. Patient or legal guardian understands and agrees to comply with all specified study requirements and provides written informed consent. Exclusion criteria: Life expectancy <12 months due to another medical condition. Contraindication to the atorvastatin and rosuvastatin. Creatinine levels more than 2.0mg/dL or ESRD. Severe hepatic dysfunction (AST and/or ALT more than 3 times the upper limit of normal). Congestive heart failure (left ventricle eject fraction ≤35%). Female of childbearing potential with a positive pregnancy test within 7 days before study, or lactating, or intends to become pregnant during the following 12 months. The patient is likely to require coronary bypass surgery, cardiac transplantation, surgical repair or replacement during the course. Exit criteria ALT/AST ≥ 3times upper limit of normal after enrollment. Muscle ache/myopathy. Lose follow-up. Patient insists on exit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Yu, MD,PhD
Organizational Affiliation
The Second Affiliated Hospital of Harbin Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
27871242
Citation
Dong N, Xie Z, Wang W, Dai J, Sun M, Pu Z, Tian J, Yu B. Comparison of coronary arterial lumen dimensions on angiography and plaque characteristics on optical coherence tomography images and their changes induced by statin. BMC Med Imaging. 2016 Nov 22;16(1):63. doi: 10.1186/s12880-016-0166-4.
Results Reference
derived

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Evaluation of Statin-induced Lipid-rich Plaque Progression by Optical Coherence Tomography (OCT) Combined With Intravascular Ultrasound (IVUS)

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