Acute Coronary SyndromeTRUSTEDNCT03841214
Study on Prediction of Left Ventricular Remodeling Using ST2
An observational study of Acute Coronary Syndrome, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
Patients who underwent percutaneous coronary intervention after diagnosis of acute coronary syndrome should be enrolled in the study and follow - up. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 114 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Feb 2019to 30 Jun 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute coronary syndrome who underwent successful percutaneous coronary intervention
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Keimyung University Dongsan Hospital
Daegu, Dalseogu, 42601
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
ST2 and LV end-diastolic volume index
the correlation between changes of ST2 and LV end-diastolic volume index
Measured: 3 months
Secondary outcomes (3)
ST2 and LV ejection fraction
the correlation between changes of ST2 and LV ejection fraction
Measured: 3 months
ST2 and E over e' ratio
the correlation between changes of ST2 and E over e' ratio
Measured: 3 months
ST2 and LV wall motion score
the correlation between changes of ST2 and LV wall motion score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start25 Feb 2019
- Primary completion31 Mar 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Hyungseop, Keimyung University Dongsan Medical Center
- Investigators
- Hyung-Seop Kim, Postdoctoral, Principal investigator, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841214
- Sponsor's protocol ID
- TRUSTED
- Acronym
- TRUSTED
- Status last verified
- Jun 2020
- First submitted
- 12 Feb 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of ST2 for impRovement of Left ventricUlar Systolic funcTion After Percutaneous Coronary Intervention in Patients With acutE Coronary synDrome
- ClinicalTrials.gov ID
- NCT03841214
- Acronym / sponsor ID
- TRUSTED / TRUSTED
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute coronary syndrome who underwent successful percutaneous coronary intervention
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ST2 and LV end-diastolic volume index
Time frame: 3 months
the correlation between changes of ST2 and LV end-diastolic volume index
3 secondary outcomes
ST2 and LV ejection fraction
Time frame: 3 months
ST2 and E over e' ratio
Time frame: 3 months
ST2 and LV wall motion score
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyung-Seop Kim, Postdoctoral principal investigator
Keimyung University Dongsan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ST2 and LV end-diastolic volume index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.