Cardiovascular Disease OtherNCT06295978
Multimarker Approach in Acute Chest Pain
An observational study of Cardiovascular Disease Other, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Chest pain is one of the most common causes of access in the Emergency Room, and it can be a clinical manifestation of a broad spectrum of diseases including those 'time dependent' conditions such as acute coronary syndrome (ACS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease Other
- What is being tested?
- Biochemical marker assays
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2021to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients entering the emergency department with chest pain or other typical symptoms suspected of ACS will be included in the study if they are adults, not pregnant, and meet the predetermined inclusion criteria. Furthermore, patients who sign written informed consent to participate in the study and to the processing of personal data
Who may be able to join
- Age ≥18 years;
- Patients who came to the emergency department with chest pain of presumable cardiac origin and uncertain etiologic diagnosis
- ECG not diagnostic for ischemia
- cTnI ultra within limits
Who cannot join
- STEMI
- Sepsis and viral infections
- Patients with ECG abnormalities that make it uninterpretable for ischemic purposes
- Patients with previous coronary events
- History of heart failure
- Known diagnosis of cardiovascular disease, acute or chronic, including pericarditis, myocarditis
- Conditions involving increases in sST2 and suPAR unrelated to cardiac causes, especially acute/chronic inflammatory or fibrotic conditions (inflammatory bowel disease, neoplasms, moderate-to-severe pulmonary fibrosis, chronic hepatopathy; autoimmune diseases)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario "A. Gemelli" IRCCS
Roma, 00168
ANDREA PICCIONI, Dr., 0630153161, andrea.piccioni@policlinicogemelli.it
About this study
Official title: Prognostic Value of Cardiovascular Risk of sST2, suPAR and High-sensitivity Troponin I in Patients With Acute Chest Pain
Chest pain is one of the most common causes of access in the Emergency Room, and it can be a clinical manifestation of a broad spectrum of diseases including those 'time dependent' conditions such as acute coronary syndrome (ACS). Diagnosis or exclusion of acute myocardial infarction (AMI) is a daily challenge in the emergency department (ED), especially when classic clinical criteria and ECG alone are unable to make the diagnosis. The ED physician has the extremely delicate task of managing patients with chest pain and being able to frame them correctly; therefore, he needs to make differential diagnosis since chest pain can be caused by non-cardiac vascular events but also extra-cardiovascular events, such as pulmonary, neurological, osteoarticular, gastrointestinal and psychological. Recently, the importance of inflammatory processes and endothelial damage in cardiovascular disease has been highlighted, and consequently the focus has been on new markers, in a "multimarker" approach in which the strengths of each are combined together to provide an optimal solution to a clinical problem.
The data suggest how a future integration of these biomarkers in the routine approach to the patient with acute chest pain in the ED might allow a better patient stratification and proper management, allowing the clinician to make an early safe discharge or a timely admission for those who deserve in-depth diagnostic-therapeutic investigation.
Read the detailed description
BACKGROUND: Chest pain is one of the most common causes of access in the Emergency Room, and it can be a clinical manifestation of a broad spectrum of diseases including those 'time dependent' conditions such as acute coronary syndrome (ACS). Diagnosis or exclusion of acute myocardial infarction (AMI) is a daily challenge in the emergency department (ED), especially when classic clinical criteria and ECG alone are unable to make the diagnosis. The ED physician has the extremely delicate task of managing patients with chest pain and being able to frame them correctly; therefore, he needs to make differential diagnosis since chest pain can be caused by non-cardiac vascular events but also extra-cardiovascular events, such as pulmonary, neurological, osteoarticular, gastrointestinal and psychological. Recently, the importance of inflammatory processes and endothelial damage in cardiovascular disease has been highlighted, and consequently the focus has been on new markers, in a "multimarker" approach in which the strengths of each are combined together to provide an optimal solution to a clinical problem.
The role of the biomarker sST2 has been widely explored in heart failure, so much so that it was included in the AHA guidelines in 2013 and 2017. Recently, several studies are also proposing a role of sST2 in the prognostic stratification of patients with Acute Coronary Syndrome and ischaemic heart disease, in association with other biomarkers even proposing a possible therapeutic differentiation.
Furthermore, current studies have explored the role of the suPAR biomarker in cardiovascular disease. Indeed, its serum levels, closely correlated with immune and inflammatory activation, reveal it as a promising prognostic indicator. Although its non-cardiac-specific nature limits its diagnostic value for heart disease, its added value in identifying patients at risk of adverse cardiovascular events, morbidity and mortality when used in a multi-marker approach has been highlighted.
The combined use of sST2 and suPAR with high-sensitivity troponins, as opposed to contemporary troponins, exploring complementary aspects of myocardial damage, could be a promising strategy to identify those patients who, although with early rule-out after evaluation in the emergency room, present a higher risk of occurrence of distant cardiovascular events, thus deserving to be subjected to a customised diagnostic-instrumental procedure.
- Conditions
- Cardiovascular Disease Other
- Being tested
- Biochemical marker assays
- Keywords
- Biomarkers, Chest pain, suPAR, sST2
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biochemical marker assaysDiagnostic test
DOSAGE BIOMARKERS
What is being measured
The primary outcome is the main question the study is designed to answer.
The predictive value of markers for the risk of cardiovascular events in chest pain
Evaluate the medium-long term (1 year) predictive value of the sST2, suPAR and IL6 biomarkers in patients attending the emergency department for acute non-STEMI chest pain
Measured: 2 years
Secondary outcomes (1)
Multimarker approach to improve cardiovascular risk stratification
A multimarker approach in combination with high-sensitivity troponin (hsTnI), improve cardiovascular risk stratification
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Feb 2021
- Primary completion31 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Disease OtherStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piccioni Andrea, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295978
- Sponsor's protocol ID
- 4896
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Cardiovascular Risk of sST2, suPAR and High-sensitivity Troponin I in Patients With Acute Chest Pain
- ClinicalTrials.gov ID
- NCT06295978
- Acronym / sponsor ID
- 4896
- Conditions
- Cardiovascular Disease Other
- Keywords
- Biomarkers, Chest pain, suPAR, sST2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Mar 2024 (actual)
- 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.
Chest pain is one of the most common causes of access in the Emergency Room, and it can be a clinical manifestation of a broad spectrum of diseases including those 'time dependent' conditions such as acute coronary syndrome (ACS). Diagnosis or exclusion of acute myocardial infarction (AMI) is a daily challenge in the emergency department (ED), especially when classic clinical criteria and ECG alone are unable to make the diagnosis. The ED physician has the extremely delicate task of managing patients with chest pain and being able to frame them correctly; therefore, he needs to make differential diagnosis since chest pain can be caused by non-cardiac vascular events but also extra-cardiovascular events, such as pulmonary, neurological, osteoarticular, gastrointestinal and psychological. Recently, the importance of inflammatory processes and endothelial damage in cardiovascular disease has been highlighted, and consequently the focus has been on new markers, in a "multimarker" approach in which the strengths of each are combined together to provide an optimal solution to a clinical problem.
The data suggest how a future integration of these biomarkers in the routine approach to the patient with acute chest pain in the ED might allow a better patient stratification and proper management, allowing the clinician to make an early safe discharge or a timely admission for those who deserve in-depth diagnostic-therapeutic investigation.
Detailed description
BACKGROUND: Chest pain is one of the most common causes of access in the Emergency Room, and it can be a clinical manifestation of a broad spectrum of diseases including those 'time dependent' conditions such as acute coronary syndrome (ACS). Diagnosis or exclusion of acute myocardial infarction (AMI) is a daily challenge in the emergency department (ED), especially when classic clinical criteria and ECG alone are unable to make the diagnosis. The ED physician has the extremely delicate task of managing patients with chest pain and being able to frame them correctly; therefore, he needs to make differential diagnosis since chest pain can be caused by non-cardiac vascular events but also extra-cardiovascular events, such as pulmonary, neurological, osteoarticular, gastrointestinal and psychological. Recently, the importance of inflammatory processes and endothelial damage in cardiovascular disease has been highlighted, and consequently the focus has been on new markers, in a "multimarker" approach in which the strengths of each are combined together to provide an optimal solution to a clinical problem.
The role of the biomarker sST2 has been widely explored in heart failure, so much so that it was included in the AHA guidelines in 2013 and 2017. Recently, several studies are also proposing a role of sST2 in the prognostic stratification of patients with Acute Coronary Syndrome and ischaemic heart disease, in association with other biomarkers even proposing a possible therapeutic differentiation.
Furthermore, current studies have explored the role of the suPAR biomarker in cardiovascular disease. Indeed, its serum levels, closely correlated with immune and inflammatory activation, reveal it as a promising prognostic indicator. Although its non-cardiac-specific nature limits its diagnostic value for heart disease, its added value in identifying patients at risk of adverse cardiovascular events, morbidity and mortality when used in a multi-marker approach has been highlighted.
The combined use of sST2 and suPAR with high-sensitivity troponins, as opposed to contemporary troponins, exploring complementary aspects of myocardial damage, could be a promising strategy to identify those patients who, although with early rule-out after evaluation in the emergency room, present a higher risk of occurrence of distant cardiovascular events, thus deserving to be subjected to a customised diagnostic-instrumental procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients entering the emergency department with chest pain or other typical symptoms suspected of ACS will be included in the study if they are adults, not pregnant, and meet the predetermined inclusion criteria. Furthermore, patients who sign written informed consent to participate in the study and to the processing of personal data
Key inclusion criteria (4 listed)
- Age ≥18 years;
- Patients who came to the emergency department with chest pain of presumable cardiac origin and uncertain etiologic diagnosis
- ECG not diagnostic for ischemia
- cTnI ultra within limits
Key exclusion criteria (7 listed)
- STEMI
- Sepsis and viral infections
- Patients with ECG abnormalities that make it uninterpretable for ischemic purposes
- Patients with previous coronary events
- History of heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biochemical marker assaysDOSAGE BIOMARKERS | Diagnostic test | – |
Primary outcome
The predictive value of markers for the risk of cardiovascular events in chest pain
Time frame: 2 years
Evaluate the medium-long term (1 year) predictive value of the sST2, suPAR and IL6 biomarkers in patients attending the emergency department for acute non-STEMI chest pain
1 secondary outcome
Multimarker approach to improve cardiovascular risk stratification
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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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.
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 Cardiovascular Disease Other, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Piccioni, Dr. (0630153161 ext. +39, andrea.piccioni@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The predictive value of markers for the risk of cardiovascular events in chest pain (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2024.