- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01618279
Tryptase and Coronary Heart Disease
Evaluation of Tryptase as a Biomarker of Coronary Heart Disease
Studieoversikt
Status
Detaljert beskrivelse
A series of scientific studies have evaluated the tryptase as a biomarker of coronary plaque instability, in the course of ischemic heart disease. Among these, the most recent and 'outcome' is better defined by Meixiang Xiang study, which has been conducted in 2011 on 270 patients. This study evaluated and compared the levels of tryptase in four populations:
- acute myocardial infarction (31 subjects)
- unstable angina (108 subjects)
- stable angina (36 subjects)
- coronary artery disease with coronary stenosis <50% (95 subjects). In this Chinese population the final evaluations have led to define the tryptase as a marker independent of instability of the atheromatous plaque.
In reference to the fact that there is still some correlation between tryptase and coronary plaque instability and clinical symptoms, we propose a verification study of the role of tryptase as a biomarker in acute coronary conditions by studying a large population of Italian subjects in the acute phase of pathology and follow up.
The work will be conducted on 4 patient population:
- acute coronary syndrome with ST elevation on electrocardiogram;
- acute coronary syndrome without ST elevation on electrocardiogram (acute myocardial infarction with ST-segment depression on electrocardiogram and unstable angina)
- noncritical coronary artery disease with coronary stenosis <50%;
- aortic aneurysms. Secondary endpoints will evaluate the role of tryptase in the event of major cardiovascular events.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Milano, Italia, 20162
- AO Osepdale Niguarda Ca' Granda
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Italian subjects in the acute phase of disease and follow up. The work will be on 4 patient populations:
- sindrome coronary acute ST elevation on electrocardiogram
- sindrome ACS without ST elevation on electrocardiogram (acute myocardial infarction with ST-segment depression on electrocardiogram and unstable angina)
- malattia critical coronary artery stenosis <50%
- aneurismi aorta.
Beskrivelse
Inclusion Criteria:
- male and female subjects aged 18 to 80 years
- patients with clinical manifestations have been discovered and documented symptoms of coronary heart disease
- all patients with these characteristics will necessarily have to sign the informed consent for inclusion in the study
Exclusion Criteria:
- patients with allergy symptoms in place (hives, uncontrolled asthma) autoimmune diseases, mastocytosis, hypereosinophilia, myelodysplastic syndrome, cancer, kidney failure
- those who deny consent to participate
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Bare etui
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
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Tryptase
Patients with clinical manifestations have been discovered and documented symptoms of coronary heart
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
serum level of tryptase as a biomarker in coronary
Tidsramme: 6 months
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dose level of serum tryptase already performed by venipuncture from diagnostic practices
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6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Tryptase and major cardiovascular events
Tidsramme: 6 months
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correlation between the level of tryptase and probable major cardiovascular events (death, myocardial infarction or reinfarction and stroke)
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6 months
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Tryptase and major cardiovascular events
Tidsramme: 6 months
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cut-off level of tryptase distinguishing between the study population and identified individuals at risk of major cardiovascular events
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6 months
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Elide Anna Pastorello, MD, Professor, Azienda Ospedaliera Ospedale Niguarda CA' Granda
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Morici N, Farioli L, Losappio LM, Colombo G, Nichelatti M, Preziosi D, Micarelli G, Oliva F, Giannattasio C, Klugmann S, Pastorello EA. Mast cells and acute coronary syndromes: relationship between serum tryptase, clinical outcome and severity of coronary artery disease. Open Heart. 2016 Sep 27;3(2):e000472. doi: 10.1136/openhrt-2016-000472. eCollection 2016.
- Pastorello EA, Morici N, Farioli L, Di Biase M, Losappio LM, Nichelatti M, Lupica L, Schroeder JW, Stafylaraki C, Klugmann S. Serum tryptase: a new biomarker in patients with acute coronary syndrome? Int Arch Allergy Immunol. 2014;164(2):97-105. doi: 10.1159/000360164. Epub 2014 Jun 14.
- Pastorello EA, Farioli L, Losappio LM, Morici N, Di Biase M, Nichelatti M, Schroeder JW, Balossi L, Klugmann S. Serum tryptase detected during acute coronary syndrome is significantly related to the development of major adverse cardiovascular events after 2 years. Clin Mol Allergy. 2015 Jun 2;13(1):14. doi: 10.1186/s12948-015-0013-0. eCollection 2015.
- Losappio LM, Mirone C, Chevallard M, Farioli L, De Luca F, Pastorello EA. Tryptase as a marker of severity of aortic valve stenosis. Clin Mol Allergy. 2018 Aug 7;16:17. doi: 10.1186/s12948-018-0095-6. eCollection 2018.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 193_05/2012
Legemiddel- og utstyrsinformasjon, studiedokumenter
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