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

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ClinicalTrials.gov Identifier: NCT03841214
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Kim Hyungseop, Keimyung University Dongsan Medical Center

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

Condition or disease
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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 304 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Prediction of ST2 for impRovement of Left ventricUlar Systolic funcTion After Percutaneous Coronary Intervention in Patients With acutE Coronary synDrome
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. ST2 and LV end-diastolic volume index [ Time Frame: 3 months ]
    the correlation between changes of ST2 and LV end-diastolic volume index


Secondary Outcome Measures :
  1. ST2 and LV ejection fraction [ Time Frame: 3 months ]
    the correlation between changes of ST2 and LV ejection fraction

  2. ST2 and E over e' ratio [ Time Frame: 3 months ]
    the correlation between changes of ST2 and E over e' ratio

  3. ST2 and LV wall motion score [ Time Frame: 3 months ]
    the correlation between changes of ST2 and LV wall motion score


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with acute coronary syndrome who underwent successful percutaneous coronary intervention
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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841214


Contacts
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Contact: Hyung-Seop Kim, Postdoctoral 82-53-258-4625 khyungseop@dsmc.or.kr
Contact: Yun-Kyeong Cho, Postdoctoral 82-53-258-6663 ds010042@gmail.com

Locations
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Korea, Republic of
Keimyung University Dongsan Hospital Recruiting
Daegu, Dalseogu, Korea, Republic of, 42601
Contact: Hyungseop Kim, Professor    +82-53-258-7718    khyungseop@dsmc.or.kr   
Contact: Yun-Kyeong Cho, Professor    +82-53-258-7728    ds010042@gmail.com   
Sponsors and Collaborators
Keimyung University Dongsan Medical Center
Investigators
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Principal Investigator: Hyung-Seop Kim, Postdoctoral Keimyung University Dongsan Medical Center
More Information
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Additional Information:

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Responsible Party: Kim Hyungseop, Professor, Keimyung University Dongsan Medical Center
ClinicalTrials.gov Identifier: NCT03841214    
Other Study ID Numbers: TRUSTED
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases