Clinical trial NCT01290770: Search a Correlation Between Lp(a) Rate and TFPI Activity in Obese Patients With Chest Pain Like Angina
Official title: Search a Correlation Between Lipoprotein(a) Rate and TFPI(Tissue Factor Pathway Inhibitor)Activity in Obese Patients With Chest Pain Like Angina
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atherosclerosis
Keywords: obesity
men
TFPI
Lipoprotein(a)
Lp(a)
Tissue Factor pathway inhibitor
aspirin
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2011-02-07
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: obese men with chest pain like stable angina

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: correlation between Lp(a) and TFPI activity
timeFrame: day 1
Secondary outcomes:
measure: Correlation between Lp(a) and TFPI resistance
timeFrame: day 1
measure: Correlation between lp(a) rate and TFPI activity
timeFrame: 1 month
measure: thrombin generation
timeFrame: day 1
measure: Correlation between Lp(a) and TFPI resistance
timeFrame: 1 month
Other outcomes:
Locations:
city: Feurs
country: France
facility: Service de cardiologie - CHG Feurs
city: Firminy
country: France
facility: Service de cardiologie - CHG Firminy
city: Saint-Etienne
country: France
facility: Service de cardiologie - CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Brigitte TARDY, MD
role: PRINCIPAL_INVESTIGATOR
References: