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

NCT01290770 | Terminated

• 1 other identifier: 1008178
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Atherosclerosis

Keywords

obesity; men; TFPI; Lipoprotein(a); Lp(a); Tissue Factor pathway inhibitor; aspirin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Correlation between Lp(a) and TFPI resistance

  day 1

• Correlation between lp(a) rate and TFPI activity

  1 month

• thrombin generation

  day 1

• Correlation between Lp(a) and TFPI resistance

  1 month

Study Arms (1)

obese men

obese men with chest pain like angina

Other: blood sample

Interventions

blood sample OTHER

blood sample at inclusion and 1 month after inclusion

obese men

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

obese men with chest pain like stable angina

You may qualify if:

• Major
• Men
• Obese BMI\>30
• Coronary exploration: coronary angiography or tomography coronary angiography
• Chest pain like stable angina

You may not qualify if:

• Women
• Severe hepatic insufficiency
• Inflammatory disease
• Neoplasia
• Protein S deficiency

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (3)

Service de cardiologie - CHG Feurs

Feurs, 42110, France

Location

Service de cardiologie - CHG Firminy

Firminy, 42700, France

Location

Service de cardiologie - CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood and serum

MeSH Terms

Conditions

Atherosclerosis; Obesity; Multiple Endocrine Neoplasia Type 1

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Brigitte TARDY, MD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 7, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2014
• Last Updated: September 29, 2014

Record last verified: 2014-09

Locations

FR (3)