Tryptase and Coronary Heart Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Tryptase as a Biomarker of Coronary Heart Disease

Conditions
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Acute Coronary Syndrome With ST Elevation on Electrocardiogram, Acute Coronary Syndrome Without ST Elevation on Electrocardiogram, Noncritical Coronary Artery Disease Coronary Stenosis Less Than 50 Per Cent, Aortic Aneurysms

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tryptase<br>Patients with clinical manifestations have been discovered and documented symptoms of coronary heart | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum level of tryptase as a biomarker in coronary | dose level of serum tryptase already performed by venipuncture from diagnostic practices | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tryptase, coronary, stemi, nstemi