Relevance of Plasma PCSK9 Concentration as a Biomarker in Acute Coronary Syndrome.
- Conditions
- Acute Coronary Syndrome
- Interventions
- Other: biological parameters dosage
- Registration Number
- NCT01109706
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 175
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description patient treated by statines biological parameters dosage - patient without normolipidemic treatment biological parameters dosage -
- Primary Outcome Measures
Name Time Method Syntax score (for evaluate coronary damages) and plasmatic concentration of PCSK9 Day 1, Day 2, Day 3, Day 4 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).
- Secondary Outcome Measures
Name Time Method kinetic of PCSK9 after intensive care Day 1, Day 2, Day 3, Day 4 Determination of PCSK9 kinetic variation at 1 and 6 months after intensive care, during their normal follow-up
association between PCSK9 and metabolic/inflammatory factors Day 1, Day 2, Day 3, Day 4 Identification of metabolic and inflammatory factors (glycemia, insulinemia, HbA1C, CRPus...) associated to plasma PCSK9 concentration
kinetic of PCSK9 for statin-treated patients Day 1, Day 2, Day 3, Day 4 Measurement of PCSK9 kinetic variation during ACS acute phase in patients treated with artovastatin 80 mg/day (J1, J2, J3, and J4)
Correlation between PCSK9 and morbidity/mortality Day 1, Day 2, Day 3, Day 4 Assessing the correlation between plasma PCSK9 (J1, J2, J3, J4) concentration and one-year morbidity/mortality of patients with acute coronary syndrome
Trial Locations
- Locations (2)
Nantes University hospital
🇫🇷Nantes, France
Nantes University Hospital
🇫🇷Nantes, France