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NCT04460131 Clinical Trial

Soluble ST2 and Cardiovascular Outcome

Cardiovascular Disease Clinical Trial

Official title:
Association Between Soluble ST2 and Cardiovascular Outcome After Cardiovascular Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04460131
Other study ID # sST2-2019
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 31, 2025

Study information
Verified date April 2022
Source Nanjing Medical University
Contact Yong-feng Shao
Phone +8618801281613
Email yfshaojph@sina.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cardiac surgery induces hemodynamic stress on the myocardium, and this process can be associated with significant cardiovascular morbidity and mortality. Soluble suppression of tumorigenicity 2 (sST2) is biomarker of myocardial remodeling and fibrosis; however, little is known regarding their potential association with cardiovascular events. This study aimed to investigate the release of sST2 and its association with cardiovascular events undergoing cardiac surgery.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - age = 18 years - Congenital heart disease requiring surgery - Valvular heart disease requiring surgery - Arrhythmia requiring surgery - Aortic dissection requiring surgery - Coronary heart disease requiring surgery Exclusion Criteria: - age <18 years - pregnancy - severe renal dysfunction (creatinine >200µmol/L) - not capable of understanding or signing informed consent.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• soluble ST2
Serum sST2 was measured on a monoclonal electrochemiluminescence immunoassay. Samples were exposed to two freeze cycles before analysed. Samples were exposed to two thawfreeze cycles before analysed.

Locations
Country Name City State
China The first affiliated hospital of nanjing medical university Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary All-cause mortality Number of participants death of 30 days after surgery 30 days after surgery
Secondary Heart failure requiring initiation or change in heart failure medication or requiring hospitalisation 30 days after surgery
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