Relevance of Plasma PCSK9 Concentration as a Biomarker in Acute Coronary Syndrome.

NCT01109706 | Completed

• 1 other identifier: BRD/10/03-ZE
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Coronary Syndrome

Keywords

Acute coronary syndrome; PCSK9; cardiovascular safety

Outcome Measures

Primary Outcomes (1)

• Syntax score (for evaluate coronary damages) and plasmatic concentration of PCSK9

  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

Secondary Outcomes (4)

• Correlation between PCSK9 and morbidity/mortality

  Day 1, Day 2, Day 3, Day 4

• association between PCSK9 and metabolic/inflammatory factors

  Day 1, Day 2, Day 3, Day 4

• kinetic of PCSK9 for statin-treated patients

  Day 1, Day 2, Day 3, Day 4

• kinetic of PCSK9 after intensive care

  Day 1, Day 2, Day 3, Day 4

Study Arms (2)

patient treated by statines

Other: biological parameters dosage

patient without normolipidemic treatment

Other: biological parameters dosage

Interventions

biological parameters dosage OTHER

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.

patient treated by statines; patient without normolipidemic treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of both sexes, 18 years old minimum, with an acute coronary syndrome, treated or not with statins, admitted to cardiological intensive care unit.

You may qualify if:

• more than 18 years old
• Acute coronary syndrome (ST+ or ST-)
• groups of patients: with statin, and without statin treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (2)

Nantes University hospital

Nantes, 44000, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Bertrand Cariou, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: April 23, 2010
• Study Start: February 13, 2011
• Primary Completion: September 24, 2013
• Study Completion: July 16, 2015
• Last Updated: September 20, 2021

Record last verified: 2021-09

Locations

FR (2)