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Clinical Trials/NCT01618279
NCT01618279
Completed
Not Applicable

Evaluation of Tryptase as a Biomarker of Coronary Heart Disease

Niguarda Hospital1 site in 1 country350 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Coronary Syndrome With ST Elevation on Electrocardiogram
Sponsor
Niguarda Hospital
Enrollment
350
Locations
1
Primary Endpoint
serum level of tryptase as a biomarker in coronary
Status
Completed
Last Updated
4 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
January 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

serum level of tryptase as a biomarker in coronary

Time Frame: 6 months

dose level of serum tryptase already performed by venipuncture from diagnostic practices

Secondary Outcomes

  • Tryptase and major cardiovascular events(6 months)

Study Sites (1)

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