Tryptase and Coronary Heart Disease

This study is currently recruiting participants.
Verified March 2014 by Niguarda Hospital
Sponsor:
Information provided by (Responsible Party):
Niguarda Hospital
ClinicalTrials.gov Identifier:
NCT01618279
First received: June 11, 2012
Last updated: March 6, 2014
Last verified: March 2014

June 11, 2012
March 6, 2014
January 2013
June 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01618279 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Venous blood

Non-Probability Sample

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.
  • 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
Not Provided
Tryptase
Patients with clinical manifestations have been discovered and documented symptoms of coronary heart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
January 2015
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
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
Italy
 
NCT01618279
193_05/2012
No
Niguarda Hospital
Niguarda Hospital
Not Provided
Principal Investigator: Elide Anna Pastorello, MD, Professor Azienda Ospedaliera Ospedale Niguarda Ca' Granda
Niguarda Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP