- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01290770
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.
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Feurs, Frankrig, 42110
- Service de cardiologie - CHG Feurs
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Firminy, Frankrig, 42700
- Service de cardiologie - CHG Firminy
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Saint-Etienne, Frankrig, 42055
- Service de cardiologie - CHU de Saint-Etienne
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
obese men
obese men with chest pain like angina
|
blood sample at inclusion and 1 month after inclusion
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
correlation between Lp(a) and TFPI activity
Tidsramme: day 1
|
Establish correlation between Lp(a) rate and TFPI activity in obese patients with chest pain like stable angina
|
day 1
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Correlation between Lp(a) and TFPI resistance
Tidsramme: day 1
|
Establish correlation between Lp(a) rate and TFPI resistance at inclusion and 1 month after aspirin treatment
|
day 1
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Correlation between lp(a) rate and TFPI activity
Tidsramme: 1 month
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Establish the correlation, 1 month after initiation of aspirin treatment, between lp(a) rate and TFPI activity
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1 month
|
thrombin generation
Tidsramme: day 1
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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
Tidsramme: 1 month
|
Establish correlation between Lp(a) rate and TFPI resistance at inclusion and 1 month after aspirin treatment
|
1 month
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1008178
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