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Search a Correlation Between Lp(a) Rate and TFPI Activity in Obese Patients With Chest Pain Like Angina

This study is currently recruiting participants.
Verified November 2012 by Centre Hospitalier Universitaire de Saint Etienne
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01290770
First received: February 3, 2011
Last updated: November 22, 2012
Last verified: November 2012
History of Changes
  Purpose

Atherosclerotic cardiovascular disease is a leading cause of mortality in our countries. Clinically, symptoms could be chest pain suggesting stable angina. Atherosclerosis is influenced by cardiovascular risk factors which obesity (Body Mass Index>30). Obesity is associated with an increase risk of cardiovascular complications.

Lipoprotein(a) is regarded as an independent risk factor for premature cardiovascular disease. Lp(a) is composed of low-density lipoprotein - like particle bound to glycoprotein molecule: apolipoprotein(a). Plasma levels are determinated to more than 90% by genetic factors (no significant influence of statin, weight, lifestyle factor: diet, exercise). Two study with few patients have found that aspirin lowers serum Lp(a) levels. Elevated Lp(a) is a risk factor for recurrent coronary events in obese patient.

Atherosclerosis is associated with imbalance of coagulation. TFPI (tissue factor pathway inhibitor) is the earliest inhibitor of the blood coagulation process, natural direct inhibitor of tissue factor. In-vitro, TFPI activity is inhibited by high Lp(a) .

The aim of this study is to research reverse association between Lp(a) and TFPI activity in obese patient with chest pain like stable angina suggesting atherosclerotic heart disease and effect of aspirin.


Condition Intervention
Atherosclerosis
 Other: blood sample

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Search a Correlation Between Lipoprotein(a) Rate and TFPI(Tissue Factor Pathway Inhibitor)Activity in Obese Patients With Chest Pain Like Angina

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • correlation between Lp(a) and TFPI activity [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    Establish correlation between Lp(a) rate and TFPI activity in obese patients with chest pain like stable angina


Secondary Outcome Measures:
  • Correlation between Lp(a) and TFPI resistance [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    Establish correlation between Lp(a) rate and TFPI resistance at inclusion and 1 month after aspirin treatment

  • Correlation between lp(a) rate and TFPI activity [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Establish the correlation, 1 month after initiation of aspirin treatment, between lp(a) rate and TFPI activity

  • thrombin generation [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    describe thrombin generation with calibrated automated thrombinography technique in obese patient with chest pain like angina and hight Lp(a)rate

  • Correlation between Lp(a) and TFPI resistance [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Establish correlation between Lp(a) rate and TFPI resistance at inclusion and 1 month after aspirin treatment


Biospecimen Retention:   Samples Without DNA

whole blood and serum


Estimated Enrollment: 60
Study Start Date: February 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
obese men
obese men with chest pain like angina
 Other: blood sample
blood sample at inclusion and 1 month after inclusion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

obese men with chest pain like stable angina

Criteria

Inclusion Criteria:

  • Major
  • Men
  • Obese BMI>30
  • No aspirin treatment before inclusion
  • Coronary exploration: coronary angiography or tomography coronary angiography
  • Chest pain like stable angina

Exclusion Criteria:

  • Women
  • Severe hepatic insufficiency
  • Inflammatory disease
  • Neoplasia
  • Protein S deficiency
  • Aspirin treatment 10 days before inclusion
  • Oral anticoagulant treatment at inclusion
  • Heparin or low molecular weight heparin treatment at inclusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01290770

Contacts
Contact: Arnauld Garcin +33(4)77120286 agarcin34@yahoo.fr

Locations
France
Service de cardiologie - CHG Feurs Recruiting
Feurs, France, 42110
Principal Investigator: Nathalie Pichon, MD            
Service de cardiologie - CHG Firminy Recruiting
Firminy, France, 42700
Contact: Loucif Abdellaoui, MD            
Principal Investigator: Loucif Abdellaoui, MD            
Principal Investigator: Zahi AFIF, MD            
Service de cardiologie - CHU de Saint-Etienne Recruiting
Saint-Etienne, France, 42055
Contact: Karl Isaaz, PHD            
Principal Investigator: Karl Isaaz, PhD            
Sub-Investigator: Antoine Da Costa, PhD            
Sub-Investigator: Cécile Romeyer-Bouchard, MD            
Sub-Investigator: Alexis Cerisier, MD            
Sub-Investigator: Michel Lamaud, MD            
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Brigitte TARDY, MD CHU de Saint-Etienne
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01290770     History of Changes
Other Study ID Numbers: 1008178
Study First Received: February 3, 2011
Last Updated: November 22, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
obesity
men
TFPI
Lipoprotein(a)
 Lp(a)
Tissue Factor pathway inhibitor
aspirin

Additional relevant MeSH terms:
Atherosclerosis
Chest Pain
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pain
Signs and Symptoms
Thromboplastin
Lipoprotein-associated coagulation inhibitor
Hemostatics
Coagulants
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013