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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Nantes, Francia, 44093
- Nantes University Hospital
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Nantes, Francia, 44000
- Nantes University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Otro
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Syntax score (for evaluate coronary damages) and plasmatic concentration of PCSK9
Periodo de tiempo: 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).
|
Day 1, Day 2, Day 3, Day 4
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Correlation between PCSK9 and morbidity/mortality
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Bertrand Cariou, MD, Nantes University Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BRD/10/03-ZE
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