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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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-
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Nantes, Frankrike, 44093
- Nantes university hospital
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Nantes, Frankrike, 44000
- Nantes university hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Annen
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Syntax score (for evaluate coronary damages) and plasmatic concentration of PCSK9
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Correlation between PCSK9 and morbidity/mortality
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Bertrand Cariou, MD, Nantes university hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BRD/10/03-ZE
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