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Acute Chest PainsST2NCT05752188

Prognostic Value of Cardiovascular Risk of sST2 and Troponin I-hs in Patients With Acute Chest Pain

An observational study of Acute Chest Pain and Acute Coronary Syndrome, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The role of the sST2 biomarker 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 proposing a role of sST2 in the prognostic stratification of patients with Acute Coronary Syndrome and ischemic heart disease, in association… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Acute Chest Pain, Acute Coronary Syndrome
What is being tested?
Multimarker approach in acute coronary syndrome
How many people
100 participants
Where
1 siteItaly
Study dates
3 Jul 2021to 24 Sep 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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The evaluation of the efficacy of the sST2 and cTNI HS biomarkers will be evaluated retrospectively without altering the normal diagnostic and therapeutic procedure in the recruited patients. The results of sST2 and Troponins will then be evaluated on the basis of the clinical outcomes obtained by telephone interview with the patient carried out at 1 year.

Who may be able to join

  • Age ≥ 18 years;
  • Chest pain of presumable cardiac origin and uncertain etiological diagnosis
  • ECG not diagnostic for ischemia
  • troponin values within normal ranges

Who cannot join

  • STEMI myocardial infarction
  • 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 sST2 elevations unrelated to cardiac causes, particularly acute/chronic inflammatory or fibrotic conditions (inflammatory bowel disease, malignancy, moderate to severe pulmonary fibrosis, chronic liver disease; autoimmune disorders)

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Silvia Baroni

    Roma, 00168

Other trials in Italy

About this study

Official title: Prognostic Value of Cardiovascular Risk of Soluble Suppression of Tumorigenesis-2 and High Sensitivity Troponin I in Patients With Acute Chest Pain

The role of the sST2 biomarker 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 proposing a role of sST2 in the prognostic stratification of patients with Acute Coronary Syndrome and ischemic heart disease, in association with other biomarkers even proposing a possible therapeutic differentiation. The combined use of sST2 with high-sensitivity troponins could be a promising strategy to identify those patients who, despite having early rule-out after evaluation at the Emergency Department, have a higher risk of onset of cardiovascular events in the medium-long term.

Being tested
Multimarker approach in acute coronary syndrome
Keywords
Troponin, sST2
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multimarker approach in acute coronary syndromeOther

    The main objective of the study is to evaluate the prognostic role of the biochemical marker sST2 in patients attending the Emergency Department of our hospital with acute chest pain with suspected acute coronary syndrome.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate sST2 predictive value's

    Evaluate the medium-long term (1 year) predictive value of the sST2 biomarker in the heart patients attending at the Emergency Department for non-STEMI Acute Chest Pain.

    Measured: 24 months

Secondary outcomes (2)

  1. Compare sST2 prognostic value with troponins

    Compare the prognostic value of the new biomarker with highly sensitive troponins, for which there is already evidence in the literature

    Measured: 24 months

  2. Create a multiparametric algorithm/score

    Integrate the sST2 values in a multiparametric algorithm/score for the differential diagnosis and risk stratification in medium/long-term complications.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2023
  2. Study start3 Jul 2021
  3. Primary completion8 Sep 2022
  4. Study completion24 Sep 2024

Resources

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
Retrospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05752188
Sponsor's protocol ID
3477
Acronym
sST2
Status last verified
Sep 2024
First submitted
21 Feb 2023
Last updated
26 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Aimo A, Vergaro G, Ripoli A, Bayes-Genis A, Pascual Figal DA, de Boer RA, Lassus J, Mebazaa A, Gayat E, Breidthardt T, Sabti Z, Mueller C, Brunner-La Rocca HP, Tang WH, Grodin JL, Zhang Y, Bettencourt P, Maisel AS, Passino C, Januzzi JL, Emdin M. Meta-Analysis of Soluble Suppression of Tumorigenicity-2 and Prognosis in Acute Heart Failure. JACC Heart Fail. 2017 Apr;5(4):287-296. doi: 10.1016/j.jchf.2016.12.016. Epub 2017 Feb 8.

    PubMed 28189578

  • Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available.

    PubMed 30571511

  • Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available.

    PubMed 26320110

  • Reichlin T, Schindler C, Drexler B, Twerenbold R, Reiter M, Zellweger C, Moehring B, Ziller R, Hoeller R, Rubini Gimenez M, Haaf P, Potocki M, Wildi K, Balmelli C, Freese M, Stelzig C, Freidank H, Osswald S, Mueller C. One-hour rule-out and rule-in of acute myocardial infarction using high-sensitivity cardiac troponin T. Arch Intern Med. 2012 Sep 10;172(16):1211-8. doi: 10.1001/archinternmed.2012.3698.

    PubMed 22892889

  • Januzzi JL, Pascual-Figal D, Daniels LB. ST2 testing for chronic heart failure therapy monitoring: the International ST2 Consensus Panel. Am J Cardiol. 2015 Apr 2;115(7 Suppl):70B-5B. doi: 10.1016/j.amjcard.2015.01.044. Epub 2015 Jan 24.

    PubMed 25670638

  • Sabatine MS, Morrow DA, Higgins LJ, MacGillivray C, Guo W, Bode C, Rifai N, Cannon CP, Gerszten RE, Lee RT. Complementary roles for biomarkers of biomechanical strain ST2 and N-terminal prohormone B-type natriuretic peptide in patients with ST-elevation myocardial infarction. Circulation. 2008 Apr 15;117(15):1936-44. doi: 10.1161/CIRCULATIONAHA.107.728022. Epub 2008 Mar 31.

    PubMed 18378613

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Chest Pain and Acute Coronary Syndrome, 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: finished, as of the sponsor's last update on 26 Sep 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?

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?

Evaluate sST2 predictive value's (time frame: 24 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 NCT05752188, which also lists 6 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 26 Sep 2024.

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