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Tryptase and Coronary Heart Disease

This study is not yet open for participant recruitment.
Verified June 2012 by Niguarda Hospital
Sponsor:
Information provided by (Responsible Party):
Niguarda Hospital
ClinicalTrials.gov Identifier:
NCT01618279
First received: June 11, 2012
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition
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:

U.S. FDA Resources

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: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Tryptase
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.
  Eligibility

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.
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618279

Contacts
Contact: Elide Anna Pastorello, MD, Professor +39026444 ext 4414 elide.pastorello@ospedaleniguarda.it
Contact: Laura M Losappio, MD +39026444 ext 4414 laura.losappio@ospedaleniguarda.it

Sponsors and Collaborators
Niguarda Hospital
Investigators
Principal Investigator: Elide Anna Pastorello, MD, Professor Azienda Ospedaliera Ospedale Niguarda Ca' Granda
  More Information

No publications provided

Responsible Party: Niguarda Hospital
ClinicalTrials.gov Identifier: NCT01618279     History of Changes
Other Study ID Numbers: 193_05/2012
Study First Received: June 11, 2012
Last Updated: June 12, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Niguarda Hospital:
tryptase
coronary
stemi
nstemi

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Coronary Stenosis
Acute Coronary Syndrome
Vascular Diseases
 Cardiovascular Diseases
Aortic Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 17, 2012