To Evaluate the Efficacy of Alirocumab for Neoatherosclerosis by Using OCT, in Comparison With Standard Statin Therapy (POLARIS)
Prospective Observational Study for Lesion of Neoatherosclerosis: The Efficacy of Alirocumab for the Neoatherosclerosis Reaction Investigated by Serial Optical Coherence Tomography
연구 개요
상세 설명
The investigators investigate to evaluate the efficacy of alirocumab for in-stent neoatherosclerosis. The investigators enrolled the patient who performed drug eluting stent implantation and detected in-stent neoatherosclerosis by follow up optical coherence tomography, and categorized into two group; the patients with alirocumab and rosuvastatin the investigatorsre categorized alirocumab therapy group, and the patients with rosuvastatin alone were categorized standard statin therapy group.
The investigators compare these two group for outcomes.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Hiromasa Otake, M.D., Ph.D
- 전화번호: +81-78-382-5111
- 이메일: hotake@med.kobe-u.ac.jp
연구 연락처 백업
- 이름: Yoichiro Sugizaki, M.D.
- 전화번호: +81-78-382-5111
- 이메일: you0724@med.kobe-u.ac.jp
연구 장소
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Hyogo
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Kobe, Hyogo, 일본, 650-0017
- 모병
- Kobe University Graduate School of Medicine, Department of Cardiology
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients with stent implantation who were performed coronary angiography and optical coherence tomography (OCT) follow-up of the coronary arteries were candidate.
These patients were implanted drug elutingstent including sirolimus-eluting stents (Cypher, Cordis, Miami Lakes, FL, USA), paclitaxel-eluting stents (Taxus, Boston Scientific, Natick, MA, USA), or everolimus-eluting stents (XIENCE V, Abbott Vascular, Santa Clara, CA, USA). The investigators assessed their OCT examination at the follow-up OCT time and patients who were detected NA on OCT findings were eligible for the presence study.
설명
Inclusion Criteria:
- The age at the time of consent acquisition is 20 years old or over.
- OCT Images that can be analyzed are obtained, and neoatherosclerosis existed in drug eluting stent
- lipid lowering therapy with rosuvastatin 10 mg or rosuvastatin 10 mg and aliclumab is performed.
- Baseline OCT was scheduled to be revisited within 6 to 12 months, or already performed.
- Document consent has been obtained from the subject person to this research.
Exclusion Criteria:
- Patients who have received treatment with PCSK 9 inhibitor in the past
- Patients whose treatment was interrupted before follow-up catheterization during the observation period
- Patients underwent LDL apheresis.
- In the case that the researchers judges it as inappropriate as the object of this research.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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alirocumab therapy group
patients with 10mg daily rosuvastatin and alirocumab at least 75mg every 2 weaks
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the administration of Alirocumab at least 75mg every 2 weeks
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standard statin therapy group
patient with 10mg daily rosuvastatin and never use alirocumab or other PCSK-9 inhibitor
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Lipid index change between baseline and 9 month follow-up
기간: Baseline and 9 month follow-up
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Lipid core arc was measured by every 0.2-mm interval throughout segments with neoatherosclerosis (NA) on optical coherence tomography (OCT) findings.
The mean lipid core arc was calculated for each lesion.
Then, the lipid index was calculated by multiplying the mean lipid core arc by the lipid core longitudinal length.
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Baseline and 9 month follow-up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Macrophage grade change between baseline and 9 month follow-up
기간: Baseline and 9 month follow-up
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Macrophage arc were measured on OCT images with NA every 0.2-mm intervals and divided 4 groups as follows: grade 0, no mac¬rophage; grade 1, localized macrophage accumulation (<30°); grade 2, clus¬tered accumulation ≥30° and <90°; grade 3, clus¬tered accumulation ≥90° and <270°; and grade 4, clustered accumulation ≥270° and <360° .
Macrophage grade was evaluated as summation of 0 to 4 grades across all cross section in NA.
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Baseline and 9 month follow-up
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공동 작업자 및 조사자
스폰서
수사관
- 연구 의자: Hiromasa Otake, M.D., Ph.D, Kobe University Graduate School of Medicine
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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