Tryptase and Coronary Heart Disease

Evaluation of Tryptase as a Biomarker of 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.

Study Overview

• Status: Completed
• Conditions: 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

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.

• Study Type: Observational
• Enrollment (Actual): 350

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20162
    • AO Osepdale Niguarda Ca' Granda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Italian subjects in the acute phase of disease and follow up. The work will be on 4 patient populations:

1. sindrome coronary acute ST elevation on electrocardiogram
2. sindrome ACS without ST elevation on electrocardiogram (acute myocardial infarction with ST-segment depression on electrocardiogram and unstable angina)
3. malattia critical coronary artery stenosis <50%
4. aneurismi aorta.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Tryptase; Patients with clinical manifestations have been discovered and documented symptoms of coronary heart

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Niguarda Hospital
• Investigators: Principal Investigator: Elide Anna Pastorello, MD, Professor, Azienda Ospedaliera Ospedale Niguarda CA' Granda

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: June 11, 2012
• First Submitted That Met QC Criteria: June 12, 2012
• First Posted (Estimate): June 13, 2012

Study Record Updates

• Last Update Posted (Actual): January 25, 2022
• Last Update Submitted That Met QC Criteria: January 22, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: coronary; tryptase; stemi; nstemi
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease; Aortic Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Syndrome; Acute Coronary Syndrome; Aneurysm; Coronary Stenosis; Aortic Aneurysm
• Other Study ID Numbers: 193_05/2012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No