Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Tryptase and Coronary Heart Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Niguarda Hospital
Information provided by (Responsible Party):
Niguarda Hospital Identifier:
First received: June 11, 2012
Last updated: February 19, 2015
Last verified: February 2015

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.

Acute Coronary Syndrome With ST Elevation on Electrocardiogram
Acute Coronary Syndrome Without ST Elevation on Electrocardiogram
Noncritical Coronary Artery Disease With Coronary Stenosis <50%
Aortic Aneurysms

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Tryptase as a Biomarker of Coronary Heart Disease

Resource links provided by NLM:

Further study details as provided by Niguarda Hospital:

Primary Outcome Measures:
  • serum level of tryptase as a biomarker in coronary [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    dose level of serum tryptase already performed by venipuncture from diagnostic practices

Secondary Outcome Measures:
  • Tryptase and major cardiovascular events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    correlation between the level of tryptase and probable major cardiovascular events (death, myocardial infarction or reinfarction and stroke)

  • Tryptase and major cardiovascular events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    cut-off level of tryptase distinguishing between the study population and identified individuals at risk of major cardiovascular events

Biospecimen Retention:   Samples Without DNA

Venous blood

Estimated Enrollment: 350
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Patients with clinical manifestations have been discovered and documented symptoms of coronary heart

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.

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01618279

Contact: Elide Anna Pastorello, MD, Professor +39026444 ext 4414
Contact: Laura M Losappio, MD +39026444 ext 4414

AO Osepdale Niguarda Ca' Granda Recruiting
Milano, Italy, 20162
Contact: Elide A Pastorello, MD    +39026444 ext 4414   
Principal Investigator: Elide A Pastorello, MD         
Sponsors and Collaborators
Niguarda Hospital
Principal Investigator: Elide Anna Pastorello, MD, Professor Azienda Ospedaliera Ospedale Niguarda Ca' Granda
  More Information

No publications provided

Responsible Party: Niguarda Hospital Identifier: NCT01618279     History of Changes
Other Study ID Numbers: 193_05/2012
Study First Received: June 11, 2012
Last Updated: February 19, 2015
Health Authority: Italy: Ethics Committee

Keywords provided by Niguarda Hospital:

Additional relevant MeSH terms:
Acute Coronary Syndrome
Coronary Artery Disease
Coronary Disease
Coronary Stenosis
Myocardial Ischemia
Angina Pectoris
Arterial Occlusive Diseases
Cardiovascular Diseases
Chest Pain
Heart Diseases
Signs and Symptoms
Vascular Diseases processed this record on March 03, 2015