Relevance of Plasma PCSK9 Concentration as a Biomarker in Acute Coronary Syndrome. (PC-SCA-9)
PCSK9 (Proprotein convertase subtilisin kexin type 9) plays a key role in LDL-cholesterol (LDLC) metabolism by inhibiting LDL receptor (LDLR) at post-transcriptional level. PCSK9 loss of function mutations are associated to decreased LDLC levels and a cardiovascular protection. In this context, the development of pharmacological inhibitors of PCSK9, in association with statins treatment, represents a major therapeutic issue for LDLC modulation. It was previously shown that PCSK9 plasmatic concentration correlated with plasmatic LDLC, TG and glucose concentrations. However, no data are available on predictive value of PCSK9 plasmatic level concerning coronary disease severity.
The main objective of this study is to determine whether plasmatic PCSK9 concentration is linked to coronary damage severity in patients with acute coronary syndrome.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Nantes, 프랑스, 44093
- Nantes University Hospital
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Nantes, 프랑스, 44000
- Nantes University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion criteria:
- more than 18 years old
- Acute coronary syndrome (ST+ or ST-)
- 2 groups of patients: with statin, and without statin treatment
Exclusion criteria:
- Patient who had cancer during the last 5 years or with cancer in progress
- Patient with severe infection in progress
- Hepatic failure (TP<50%)
- Severe kidney failure
- Patient unable to give his consent to the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 다른
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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patient treated by statines
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200 patients will be enrolled in the study (n=100 patients under statin treatment, n=100 patients without statin). After checking inclusion and non-inclusion criteria and obtaining informed consent from the patients. The SYNTAX score will be calculated and will allow to determine coronary analysis will be done at J1 and J4 (glucose, HbA1C, lipids, ApoA1, ApoB, sterols, plasmatic bile acids, insulinemia, creatinin clearance, hepatic function panel, CRPus and PCSK9 level assessment). Then, a sub-group of 30 patients will have supplementary blood analysis at 1 and 6 months after their admission, during their usual follow-up. |
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patient without normolipidemic treatment
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200 patients will be enrolled in the study (n=100 patients under statin treatment, n=100 patients without statin). After checking inclusion and non-inclusion criteria and obtaining informed consent from the patients. The SYNTAX score will be calculated and will allow to determine coronary analysis will be done at J1 and J4 (glucose, HbA1C, lipids, ApoA1, ApoB, sterols, plasmatic bile acids, insulinemia, creatinin clearance, hepatic function panel, CRPus and PCSK9 level assessment). Then, a sub-group of 30 patients will have supplementary blood analysis at 1 and 6 months after their admission, during their usual follow-up. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Syntax score (for evaluate coronary damages) and plasmatic concentration of PCSK9
기간: Day 1, Day 2, Day 3, Day 4
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Assessing the correlation between plasma concentration of PCSK9 and coronary damage severity in patients with acute coronary syndrome.
Coronary lesions will be measured using the SYNTAX score (J0: admission day), and PCSK9 concentration will be evaluated using blood analysis (J0 (admission), J1, J2, J3 & J4).
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Day 1, Day 2, Day 3, Day 4
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Correlation between PCSK9 and morbidity/mortality
기간: Day 1, Day 2, Day 3, Day 4
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Assessing the correlation between plasma PCSK9 (J1, J2, J3, J4) concentration and one-year morbidity/mortality of patients with acute coronary syndrome
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Day 1, Day 2, Day 3, Day 4
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association between PCSK9 and metabolic/inflammatory factors
기간: Day 1, Day 2, Day 3, Day 4
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Identification of metabolic and inflammatory factors (glycemia, insulinemia, HbA1C, CRPus…) associated to plasma PCSK9 concentration
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Day 1, Day 2, Day 3, Day 4
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kinetic of PCSK9 for statin-treated patients
기간: Day 1, Day 2, Day 3, Day 4
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Measurement of PCSK9 kinetic variation during ACS acute phase in patients treated with artovastatin 80 mg/day (J1, J2, J3, and J4)
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Day 1, Day 2, Day 3, Day 4
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kinetic of PCSK9 after intensive care
기간: Day 1, Day 2, Day 3, Day 4
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Determination of PCSK9 kinetic variation at 1 and 6 months after intensive care, during their normal follow-up
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Day 1, Day 2, Day 3, Day 4
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공동 작업자 및 조사자
수사관
- 수석 연구원: Bertrand Cariou, MD, Nantes University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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