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OpenTrials
Completed

NCT Number: NCT05752188

Prognostic Value of Cardiovascular Risk of sST2 and Troponin I-hs 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.

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Key information

Conditions

Acute Chest Pain Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Silvia Baroni

Roma, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Multimarker approach in acute coronary syndrome

Other

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.

Primary outcomes

  1. Evaluate sST2 predictive value's

    Time frame: 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 outcomes

  1. Compare sST2 prognostic value with troponins

    Time frame: 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

    Time frame: 36 months

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

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: sST2

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Mar 2, 2023
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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