Study on Prediction of Left Ventricular Remodeling Using ST2 | NCT03841214

Studies
Study on Prediction of Left Ventricular Remodeling Using ST2

NCT03841214

Sponsor

Keimyung University Dongsan Medical Center

Status

Completed

Last Update Posted

Mar 31, 2022Actual

Enrollment

114Actual

Phase

Not provided

Conditions

Acute Coronary Syndrome

Interventions

Not provided

Countries

South Korea

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

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 25, 2019Actual

Primary Completion Date

Mar 31, 2021Actual

Completion Date

Jun 30, 2021Actual

First Submitted Date

Feb 12, 2019

First Submission Date that Met QC Criteria

Feb 12, 2019

First Posted Date

Feb 15, 2019Actual

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

Mar 29, 2022

Last Update Posted Date

Mar 31, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kim Hyungseop, Professor, Keimyung University Dongsan Medical CenterPrincipal Investigator

Lead Sponsor

Keimyung University Dongsan Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Patients who underwent percutaneous coronary intervention after diagnosis of acute coronary syndrome should be enrolled in the study and follow - up.

Detailed Description

Obtain written consent for patients who meet all of the selection criteria and who do not meet the exclusion criteria.

ACS(Acute Coronary Syndrome) patients with LV systolic dysfunction(LVEF<50%) on TTE test who underwent successful PCI. At that time, patient proceed with the Baseline blood test(ST2) in hospital.

And then, Medical therapy for 3 months later patient proceed with the Follow-up blood test(ST2) and TTE in OPD.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

114Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ST2 and LV end-diastolic volume index	the correlation between changes of ST2 and LV end-diastolic volume index	3 months

Secondary Outcomes

Measure	Description	Time Frame
ST2 and LV ejection fraction	the correlation between changes of ST2 and LV ejection fraction	3 months
ST2 and E over e' ratio	the correlation between changes of ST2 and E over e' ratio

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects aged 19 or older
Patients with acute coronary syndrome who underwent successful percutaneous coronary intervention
Patients with left ventricular ejection fraction less than 50% on transthoracic echocardiography
Patients who voluntarily agreed to participate in the study

Exclusion Criteria:

Failure to obtain TIMI 3 flow after procedure
If the remaining life span is less than one year
Women who are breastfeeding or plan to become pregnant or are planning to become pregnant during the study period

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with acute coronary syndrome who underwent successful percutaneous coronary intervention

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hyung-Seop Kim, Postdoctoral	Keimyung University Dongsan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Keimyung University Dongsan Hospital		Daegu	Dalseogu	42601	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided