Study on Prediction of Left Ventricular Remodeling Using ST2 (TRUSTED)

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

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

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome

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.

• Study Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• Korea, Republic of
  • Dalseogu
    • Daegu, Dalseogu, Korea, Republic of, 42601
      • Keimyung University Dongsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with acute coronary syndrome who underwent successful percutaneous coronary intervention

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	3 months
ST2 and LV wall motion score	the correlation between changes of ST2 and LV wall motion score	3 months

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center
• Investigators: Principal Investigator: Hyung-Seop Kim, Postdoctoral, Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2019
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: February 12, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: TRUSTED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No