Study on Prediction of Left Ventricular Remodeling Using ST2

Acute Coronary Syndrome Clinical Trial

— TRUSTED  

Official title:

Prediction of ST2 for impRovement of Left ventricUlar Systolic funcTion After Percutaneous Coronary Intervention in Patients With acutE Coronary synDrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03841214
• Other study ID #: TRUSTED
• Status: Completed
• Start date: February 25, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2020
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: June 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu	Dalseogu

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ST2 and LV end-diastolic volume index	the correlation between changes of ST2 and LV end-diastolic volume index	3 months
Secondary	ST2 and LV ejection fraction	the correlation between changes of ST2 and LV ejection fraction	3 months
Secondary	ST2 and E over e' ratio	the correlation between changes of ST2 and E over e' ratio	3 months
Secondary	ST2 and LV wall motion score	the correlation between changes of ST2 and LV wall motion score	3 months