Tryptase and Coronary Heart Disease

Aortic Aneurysms Clinical Trial

Official title:

Evaluation of Tryptase as a Biomarker of Coronary Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618279
• Other study ID #: 193_05/2012
• Status: Completed
• Start date: January 2013
• Est. completion date: January 2022

Study information

• Verified date: January 2022
• Source: Niguarda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main aim of this study will evaluate differences in serum levels of tryptase in study population. Will be selected a number of 350 patients hospitalized for coronary heart disease.

Description:

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:

1. acute myocardial infarction (31 subjects)

2. unstable angina (108 subjects)

3. stable angina (36 subjects)

4. 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:

1. acute coronary syndrome with ST elevation on electrocardiogram;

2. acute coronary syndrome without ST elevation on electrocardiogram (acute myocardial infarction with ST-segment depression on electrocardiogram and unstable angina)

3. noncritical coronary artery disease with coronary stenosis <50%;

4. aortic aneurysms. Secondary endpoints will evaluate the role of tryptase in the event of major cardiovascular events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: January 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndrome With ST Elevation on Electrocardiogram
• Acute Coronary Syndrome Without ST Elevation on Electrocardiogram
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysms
• Coronary Artery Disease
• Coronary Disease
• Coronary Stenosis
• Heart Diseases
• Myocardial Ischemia
• Noncritical Coronary Artery Disease Coronary Stenosis Less Than 50 Per Cent
• Syndrome

Locations

Country	Name	City	State
Italy	AO Osepdale Niguarda Ca' Granda	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Niguarda Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. eCollection 2016. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum level of tryptase as a biomarker in coronary	dose level of serum tryptase already performed by venipuncture from diagnostic practices	6 months
Secondary	Tryptase and major cardiovascular events	correlation between the level of tryptase and probable major cardiovascular events (death, myocardial infarction or reinfarction and stroke)	6 months
Secondary	Tryptase and major cardiovascular events	cut-off level of tryptase distinguishing between the study population and identified individuals at risk of major cardiovascular events	6 months