Soluble ST2 and Cardiovascular Outcome | NCT04460131

Studies
Soluble ST2 and Cardiovascular Outcome

NCT04460131

Sponsor

Nanjing Medical University

Status

Unknown status

Last Update Posted

Apr 25, 2022Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Cardiovascular Disease

Interventions

soluble ST2

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Jul 2, 2020

First Submission Date that Met QC Criteria

Jul 2, 2020

First Posted Date

Jul 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2022

Last Update Posted Date

Apr 25, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hong Liu, Investigator of Nanjing Medical University, Nanjing Medical UniversityPrincipal Investigator

Lead Sponsor

Nanjing Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
soluble ST2	Diagnostic 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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause mortality	Number of participants death of 30 days after surgery	30 days after surgery

Secondary Outcomes

Measure	Description	Time Frame
Heart failure	requiring initiation or change in heart failure medication or requiring hospitalisation	30 days after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yong-feng Shao	Contact	+8618801281613		yfshaojph@sina.com
Hong Liu	Contact	+8618322341013		dr.hongliu@foxmail.com

Overall Officials

Name	Affiliation	Role
Yong-feng Shao	The First Affiliated Hospital with Nanjing Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The first affiliated hospital of nanjing medical university	Recruiting	Nanjing	Jiangsu	210029	China

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided