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.
Acute Coronary Syndrome With ST Elevation on Electrocardiogram
Acute Coronary Syndrome Without ST Elevation on Electrocardiogram
Noncritical Coronary Artery Disease With Coronary Stenosis <50%
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Evaluation of Tryptase as a Biomarker of Coronary Heart Disease|
- 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
- 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
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Patients with clinical manifestations have been discovered and documented symptoms of coronary heart
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.
|Contact: Elide Anna Pastorello, MD, Professor||+39026444 ext email@example.com|
|Contact: Laura M Losappio, MD||+39026444 ext firstname.lastname@example.org|
|Principal Investigator:||Elide Anna Pastorello, MD, Professor||Azienda Ospedaliera Ospedale Niguarda Ca' Granda|