Acute Coronary Syndrome With ST Elevation on ElectrocardiogramNCT01618279
Tryptase and Coronary Heart Disease
An observational study of Acute Coronary Syndrome With ST Elevation on Electrocardiogram and Acute Coronary Syndrome Without ST Elevation on Electrocardiogram, run by Niguarda Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome With ST Elevation on Electrocardiogram, Acute Coronary Syndrome Without ST Elevation on Electrocardiogram, Noncritical Coronary Artery Disease Coronary Stenosis Less Than 50 Per Cent
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- patients with allergy symptoms in place (hives, uncontrolled asthma) autoimmune diseases, mastocytosis, hypereosinophilia, myelodysplastic syndrome, cancer, kidney failure
- those who deny consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Acute Coronary Syndrome With ST Elevation on Electrocardiogram, Acute Coronary Syndrome Without ST Elevation on Electrocardiogram, Noncritical Coronary Artery Disease Coronary Stenosis Less Than 50 Per Cent, Aortic Aneurysms
- Keywords
- tryptase, coronary, stemi, nstemi
- Medical subject headings
- Aortic Aneurysm, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tryptase | Patients with clinical manifestations have been discovered and documented symptoms of coronary heart |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum level of tryptase as a biomarker in coronary
dose level of serum tryptase already performed by venipuncture from diagnostic practices
Measured: 6 months
Secondary outcomes (2)
Tryptase and major cardiovascular events
correlation between the level of tryptase and probable major cardiovascular events (death, myocardial infarction or reinfarction and stroke)
Measured: 6 months
Tryptase and major cardiovascular events
cut-off level of tryptase distinguishing between the study population and identified individuals at risk of major cardiovascular events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2021
- Study completionJan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary Syndrome With ST Elevation on ElectrocardiogramStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elide Anna Pastorello, MD, Professor, Principal investigator, Azienda Ospedaliera Ospedale Niguarda Ca' Granda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618279
- Sponsor's protocol ID
- 193_05/2012
- Status last verified
- Jan 2022
- First submitted
- 11 Jun 2012
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27752333Pastorello 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.
PubMed 24943670Pastorello 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.
PubMed 26038676Losappio 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.
PubMed 30093839
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tryptase as a Biomarker of Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT01618279
- Acronym / sponsor ID
- 193_05/2012
- Conditions
- Acute Coronary Syndrome With ST Elevation on Electrocardiogram, Acute Coronary Syndrome Without ST Elevation on Electrocardiogram, Noncritical Coronary Artery Disease Coronary Stenosis Less Than 50 Per Cent, Aortic Aneurysms
- Keywords
- tryptase, coronary, stemi, nstemi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 13 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tryptase | – | –Patients with clinical manifestations have been discovered and documented symptoms of coronary heart |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- patients with allergy symptoms in place (hives, uncontrolled asthma) autoimmune diseases, mastocytosis, hypereosinophilia, myelodysplastic syndrome, cancer, kidney failure
- those who deny consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
serum level of tryptase as a biomarker in coronary
Time frame: 6 months
dose level of serum tryptase already performed by venipuncture from diagnostic practices
2 secondary outcomes
Tryptase and major cardiovascular events
Time frame: 6 months
Tryptase and major cardiovascular events
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Background: PubMed 27752333Morici 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.
- Background: PubMed 24943670Pastorello 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.
- Background: PubMed 26038676Pastorello 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.
- Background: PubMed 30093839Losappio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elide Anna Pastorello, MD, Professor principal investigator
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome With ST Elevation on Electrocardiogram and Acute Coronary Syndrome Without ST Elevation on Electrocardiogram, run by Niguarda Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum level of tryptase as a biomarker in coronary (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01618279, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.