NCT04460131

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

7 years

First QC Date

July 2, 2020

Last Update Submit

April 15, 2022

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    Number of participants death of 30 days after surgery

    30 days after surgery

Secondary Outcomes (1)

  • Heart failure

    30 days after surgery

Interventions

soluble ST2DIAGNOSTIC_TEST

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.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive adults patients with heart disease who underwent cardiac surgery were included.

You may qualify if:

  • 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

You may not qualify if:

  • age \<18 years
  • pregnancy
  • severe renal dysfunction (creatinine \>200µmol/L)
  • not capable of understanding or signing informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated hospital of nanjing medical university

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Yong-feng Shao

    The First Affiliated Hospital with Nanjing Medical University

    STUDY CHAIR

Central Study Contacts

Yong-feng Shao

CONTACT

+8618801281613yfshaojph@sina.com

Hong Liu

CONTACT

+8618322341013dr.hongliu@foxmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator of Nanjing Medical University

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 7, 2020

Study Start

January 1, 2019

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 25, 2022

Record last verified: 2022-04

Locations

CN(1)