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NCT Number: NCT01618279

Tryptase and Coronary Heart Disease

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.

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Key information

Conditions

Acute Coronary Syndrome With ST Elevation on Electrocardiogram Acute Coronary Syndrome Without ST Elevation on Electrocardiogram Aneurysm Aortic Aneurysm Aortic Aneurysms Aortic Diseases Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Non-ST Elevated Myocardial Infarction Noncritical Coronary Artery Disease Coronary Stenosis Less Than 50 Per Cent Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AO Osepdale Niguarda Ca' Granda

Milan, 20162, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Tryptase and major cardiovascular events

    Time frame: 6 months

    correlation between the level of tryptase and probable major cardiovascular events (death, myocardial infarction or reinfarction and stroke)

  2. Tryptase and major cardiovascular events

    Time frame: 6 months

    cut-off level of tryptase distinguishing between the study population and identified individuals at risk of major cardiovascular events

Sponsors and collaborators

Lead sponsor

Niguarda Hospital

Other

Registry information

Official study title

Evaluation of Tryptase as a Biomarker of Coronary Heart Disease

Important dates

Study start
2013
Primary completion
2021
Study completion
2022
First posted
Jun 13, 2012
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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