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

Search a Correlation Between Lipoprotein(a) Rate and TFPI(Tissue Factor Pathway Inhibitor)Activity in Obese Patients With Chest Pain Like Angina

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.

Study Overview

• Status: Terminated
• Conditions: Atherosclerosis
• Intervention / Treatment: Other: blood sample

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• France
  • Feurs, France, 42110
    • Service de cardiologie - CHG Feurs
  • Firminy, France, 42700
    • Service de cardiologie - CHG Firminy
  • Saint-Etienne, France, 42055
    • Service de cardiologie - CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

obese men with chest pain like stable angina

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
obese men; obese men with chest pain like angina	Other: blood sample; blood sample at inclusion and 1 month after inclusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation between Lp(a) and TFPI activity	Establish correlation between Lp(a) rate and TFPI activity in obese patients with chest pain like stable angina	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between Lp(a) and TFPI resistance	Establish correlation between Lp(a) rate and TFPI resistance at inclusion and 1 month after aspirin treatment	day 1
Correlation between lp(a) rate and TFPI activity	Establish the correlation, 1 month after initiation of aspirin treatment, between lp(a) rate and TFPI activity	1 month
thrombin generation	describe thrombin generation with calibrated automated thrombinography technique in obese patient with chest pain like angina and hight Lp(a)rate	day 1
Correlation between Lp(a) and TFPI resistance	Establish correlation between Lp(a) rate and TFPI resistance at inclusion and 1 month after aspirin treatment	1 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: February 3, 2011
• First Submitted That Met QC Criteria: February 4, 2011
• First Posted (Estimate): February 7, 2011

Study Record Updates

• Last Update Posted (Estimate): September 29, 2014
• Last Update Submitted That Met QC Criteria: September 26, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: obesity; Lipoprotein(a); aspirin; men; Lp(a); TFPI; Tissue Factor pathway inhibitor
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Atherosclerosis
• Other Study ID Numbers: 1008178