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Soluble ST2 and Cardiovascular Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04460131
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Hong Liu, Nanjing Medical University

Brief 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.

Condition or disease Intervention/treatment
Cardiovascular Disease Diagnostic Test: soluble ST2

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association Between Soluble ST2 and Cardiovascular Outcome After Cardiovascular Surgery
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 30 days after surgery ]

Secondary Outcome Measures :
  1. Heart failure [ Time Frame: 30 days after surgery ]
    requiring initiation or change in heart failure medication or requiring hospitalisation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Consecutive adults patients with heart disease who underwent cardiac surgery were included.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04460131


Contacts
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Contact: Yong-feng Shao +8618801281613 yfshaojph@sina.com
Contact: Hong Liu +8618322341013 dr.hongliu@foxmail.com

Locations
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China, Jiangsu
The first affiliated hospital of nanjing medical university Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Hong Liu, MD    188012181613    dr.hongliu@foxmail.com   
Sponsors and Collaborators
Nanjing Medical University
Investigators
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Study Chair: Yong-feng Shao The First Affiliated Hospital with Nanjing Medical University
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Responsible Party: Hong Liu, Investigator of Nanjing Medical University, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT04460131    
Other Study ID Numbers: sST2-2019
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases