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Relevance of Plasma PCSK9 Concentration as a Biomarker in Acute Coronary Syndrome. (PC-SCA-9)

This study is currently recruiting participants.
Verified November 2012 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01109706
First received: April 20, 2010
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Acute Coronary Syndrome
 Other: biological parameters dosage

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Relevance of Plasma PCSK9 Concentration as a Biomarker in Acute Coronary Syndrome.

Resource links provided by NLM:

MedlinePlus related topics: Statins
U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Syntax score (for evaluate coronary damages) and plasmatic concentration of PCSK9 [ Designated as safety issue: No ]
    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:
  • Correlation between PCSK9 and morbidity/mortality [ Designated as safety issue: No ]
    Assessing the correlation between plasma PCSK9 (J1, J2, J3, J4) concentration and one-year morbidity/mortality of patients with acute coronary syndrome

  • association between PCSK9 and metabolic/inflammatory factors [ Designated as safety issue: No ]
    Identification of metabolic and inflammatory factors (glycemia, insulinemia, HbA1C, CRPus…) associated to plasma PCSK9 concentration

  • kinetic of PCSK9 for statin-treated patients [ Designated as safety issue: No ]
    Measurement of PCSK9 kinetic variation during ACS acute phase in patients treated with artovastatin 80 mg/day (J1, J2, J3, and J4)

  • kinetic of PCSK9 after intensive care [ Designated as safety issue: No ]
    Determination of PCSK9 kinetic variation at 1 and 6 months after intensive care, during their normal follow-up


Biospecimen Retention:   Samples With DNA

whole blood


Estimated Enrollment: 200
Study Start Date: October 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
patient treated by statines Other: biological parameters dosage

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 without normolipidemic treatment Other: biological parameters dosage

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109706

Contacts
Contact: Bertrand Cariou, MD 02 53 48 27 10 bertrand.cariou@univ-nantes.fr

Locations
France
Nantes University hospital Recruiting
Nantes, France, 44000
Contact: Bertrand Cariou, MD     02 53 48 27 10     bertrand.cariou@univ-nantes.fr    
Principal Investigator: Bertrand Cariou, MD            
Sub-Investigator: Vicent Probst, MD            
Sub-Investigator: Jean-Noel Trochu, MD            
Sub-Investigator: Vincent Letocart, MD            
Sub-Investigator: Patrice Guerin, MD            
Sub-Investigator: Krempf Michel, MD            
Sub-Investigator: Delphine Drui, MD            
Sub-Investigator: Lucie Chaillous, MD            
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Bertrand Cariou, MD     02 53 48 27 10     bertrand.cariou@chu-nantes.fr    
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Bertrand Cariou, MD Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01109706     History of Changes
Other Study ID Numbers: BRD 10/3-ZE
Study First Received: April 20, 2010
Last Updated: November 16, 2012
Health Authority: France: Institutional Ethical Committee

Keywords provided by Nantes University Hospital:
Acute coronary syndrome
PCSK9
cardiovascular safety

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
 Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013