NCT01618279

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

8.9 years

First QC Date

June 11, 2012

Last Update Submit

January 22, 2022

Conditions

Acute Coronary Syndrome With ST Elevation on ElectrocardiogramAcute Coronary Syndrome Without ST Elevation on ElectrocardiogramNoncritical Coronary Artery Disease Coronary Stenosis Less Than 50 Per CentAortic Aneurysms

Keywords

tryptasecoronarysteminstemi

Outcome Measures

Primary Outcomes (1)

  • serum level of tryptase as a biomarker in coronary

    dose level of serum tryptase already performed by venipuncture from diagnostic practices

    6 months

Secondary Outcomes (2)

  • Tryptase and major cardiovascular events

    6 months

  • Tryptase and major cardiovascular events

    6 months

Study Arms (1)

Tryptase

Patients with clinical manifestations have been discovered and documented symptoms of coronary heart

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • male and female subjects aged 18 to 80 years
  • patients with clinical manifestations have been discovered and documented symptoms of coronary heart disease

You may not qualify if:

  • patients with allergy symptoms in place (hives, uncontrolled asthma) autoimmune diseases, mastocytosis, hypereosinophilia, myelodysplastic syndrome, cancer, kidney failure
  • those who deny consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AO Osepdale Niguarda Ca' Granda

Milan, 20162, Italy

Location

Related Publications (4)

  • 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.

    PMID: 27752333BACKGROUND

  • 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.

    PMID: 24943670BACKGROUND

  • 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.

    PMID: 26038676BACKGROUND

  • 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.

    PMID: 30093839BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood

MeSH Terms

Conditions

Aortic AneurysmST Elevation Myocardial InfarctionNon-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesMyocardial InfarctionMyocardial IschemiaHeart DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Elide Anna Pastorello, MD, Professor

    Azienda Ospedaliera Ospedale Niguarda Ca' Granda

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2012

First Posted

June 13, 2012

Study Start

January 1, 2013

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

January 25, 2022

Record last verified: 2022-01

Locations

IT(1)