ClinicalTrials.gg
CompletedNCT05752188sST2Updated Sep 26, 2024

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

An observational study in Acute Chest Pain and Acute Coronary Syndrome, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Completed at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-09-26.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years to 90 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Acute Chest Pain
  • Acute Coronary Syndrome

Keywords

  • Troponin
  • sST2
03

In context

Acute Coronary Syndrome

1,492 studies on the registry are indexed under Acute Coronary Syndrome; 270 are open to participants now.

This study's enrollment of 100 is below the median of 500 across 579 observational studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 948 studies on the registry; 537 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • OtherMultimarker approach in acute coronary syndrome

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 24 months

Secondary outcomes

  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

    Time frame: 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.

    Time frame: 36 months

07

Study locations

1 site
  • Silvia Baroni
    Roma, 00168, Italy
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2021 to primary completion in Sep 2022, 14 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 21, 2023
First posted
Mar 2, 2023
StartActual
Jul 3, 2021
Primary completionActual
Sep 8, 2022
CompletionActual
Sep 24, 2024
Last update
Sep 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05752188
Responsible party
Baroni Silvia (Confirmed researcher - Adjunct Professor-M.D., Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Mar 2, 2023
Start date
Jul 3, 2021
Primary completion
Sep 8, 2022
Completion
Sep 24, 2024
Last update
Sep 26, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion