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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05752188
Collaborator
(none)
100
1
29.9
3.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Multimarker approach in acute coronary syndrome

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Prognostic Value of Cardiovascular Risk of Soluble Suppression of Tumorigenesis-2 and High Sensitivity Troponin I in Patients With Acute Chest Pain
Actual Study Start Date :
Jul 3, 2021
Actual Primary Completion Date :
Sep 8, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Outcome Measures

Primary Outcome Measures

  1. Evaluate sST2 predictive value's [24 months]

    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.

Secondary Outcome Measures

  1. Compare sST2 prognostic value with troponins [24 months]

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

  2. Create a multiparametric algorithm/score [36 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Silvia Baroni Roma Italy 00168

Sponsors and Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Baroni Silvia, Confirmed researcher - Adjunct Professor-M.D., Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:
NCT05752188
Other Study ID Numbers:
  • 3477
First Posted:
Mar 2, 2023
Last Update Posted:
Mar 2, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Baroni Silvia, Confirmed researcher - Adjunct Professor-M.D., Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2023