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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01290770
• Other study ID #: 1008178
• Status: Terminated
• Phase: N/A
• First received: February 3, 2011
• Last updated: September 26, 2014
• Start date: February 2011
• Est. completion date: April 2014

Study information

• Verified date: September 2014
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: April 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Chest Pain

Intervention

Other:
• blood sample
blood sample at inclusion and 1 month after inclusion

Locations

Country	Name	City	State
France	Service de cardiologie - CHG Feurs	Feurs
France	Service de cardiologie - CHG Firminy	Firminy
France	Service de cardiologie - CHU de Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No