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

Terminated

• Conditions: Atherosclerosis
• Interventions: Other: blood sample

• Registration Number: NCT01290770
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-03
• Study First Submitted QC: 2011-02-04
• Study First Posted: 2011-02-07
• Primary Completion: 2014-02
• Study Completion: 2014-04
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-26
• Last Update Posted: 2014-09-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
obese men	blood sample	obese men with chest pain like angina

Primary Outcome Measures

Name	Time	Method
correlation between Lp(a) and TFPI activity	day 1	Establish correlation between Lp(a) rate and TFPI activity in obese patients with chest pain like stable angina

Secondary Outcome Measures

Name	Time	Method
thrombin generation	day 1	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	1 month	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	1 month	Establish the correlation, 1 month after initiation of aspirin treatment, between lp(a) rate and TFPI activity

Trial Locations

Locations (3)

Service de cardiologie - CHG Feurs; 🇫🇷 Feurs, France

Service de cardiologie - CHG Firminy; 🇫🇷 Firminy, France

Service de cardiologie - CHU de Saint-Etienne; 🇫🇷 Saint-Etienne, France