Myocardial InfarctionNCT02830217
Evaluation of Soluble ST2 in Patients Receiving Primary PCI With ST-elevation Myocardial Infarction
An observational study of Myocardial Infarction and Shock, run by Wuhan Asia Heart Hospital at 1 site in China.
Trial summary
ST-elevation myocardial infarction (STEMI) is an urgent symptom associated with sudden myocardial ischemia and ST segment elevated in ECG. Primary percutaneous coronary intervention (PCI) re-open infarct artery efficiently for STEMI patients. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Myocardial Infarction, Shock
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to 20 Dec 2018
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese han population in middle China
Who may be able to join
- Patients with first onset STEMI receive primary PCI according to 2013 ACCF/AHA guideline for management of STEMI
Who cannot join
- Patients with previous stroke, pneumonia, cirrhosis, autoimmune diseases or severe infection are excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Soluble ST2 to Predict Clinical Outcomes in Patients Receiving Primary Percutaneous Coronary Intervention With ST-elevation Myocardial Infarction
ST-elevation myocardial infarction (STEMI) is an urgent symptom associated with sudden myocardial ischemia and ST segment elevated in ECG. Primary percutaneous coronary intervention (PCI) re-open infarct artery efficiently for STEMI patients. However, patients are readmitted shortly after the primary PCI for several unfavorable clinical outcomes including thrombosis in stent, recurrence of myocardial infarction, stroke, and heart failure. This study is intended to test the predictive ability of a new biomarker soluble ST2 (sST2) in peripheral blood. Previous studies have shown that elevated sST2 is highly associated with unfavorable clinical outcomes of patients with ischemia heart diseases and heart failure. This study will further investigate the ability of sST2 to predict unfavorable outcomes for STEMI patients after primary PCI.
- Conditions
- Myocardial Infarction, Shock
- Keywords
- STEMI, primary PCI, sST2, prognosis
- Medical subject headings
- Myocardial Infarction, Shock, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| STEMI patients having primary PCI | Patients with STEMI receiving primary PCI in Wuhan Aisa Heart Hospital are included in this study. All patients are the first time to have STEMI, and primary PCIs are performed according to 2013 ACCF/AHA guideline for the management of STEMI. Patients with previous stroke, pneumonia, cirrhosis, autoimmune diseases are excluded from this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
stent restenosis
Evidence of stent restenosis of the patients receiving primary PCI, confirmed by coronary angiography when patients are readmitted due to the related symptoms.
Measured: one year after primary PCI
recurrence of myocardial infarction
Evidence of myocardial infarction of the patients receiving primary PCI, confirmed by coronary angiography or ECG when patients are readmitted due to the related symptoms.
Measured: one year after primary PCI
heart failure
Evidence of heart failure of the patients receiving primary PCI, confirmed by clinical diagnosis when patients are readmitted due to the related symptoms.
Measured: one year after primary PCI
cardiac death
Evidence of death due to the cardiac dysfunction of the patients receiving primary PCI.
Measured: one year after primary PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startDec 2015
- Primary completion30 Nov 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan Asia Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuan Zheng, Wuhan Asia Heart Hospital
- Investigators
- Xuan Zheng, MD,PhD, Principal investigator, Wuhan Asia Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830217
- Sponsor's protocol ID
- 2016LMC-1
- Status last verified
- Oct 2019
- First submitted
- 8 Jul 2016
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Soluble ST2 to Predict Clinical Outcomes in Patients Receiving Primary Percutaneous Coronary Intervention With ST-elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02830217
- Acronym / sponsor ID
- 2016LMC-1
- Conditions
- Myocardial Infarction, Shock
- Keywords
- STEMI, primary PCI, sST2, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Wuhan Asia Heart HospitalUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 12 Jul 2016 (estimated)
- 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.
ST-elevation myocardial infarction (STEMI) is an urgent symptom associated with sudden myocardial ischemia and ST segment elevated in ECG. Primary percutaneous coronary intervention (PCI) re-open infarct artery efficiently for STEMI patients. However, patients are readmitted shortly after the primary PCI for several unfavorable clinical outcomes including thrombosis in stent, recurrence of myocardial infarction, stroke, and heart failure. This study is intended to test the predictive ability of a new biomarker soluble ST2 (sST2) in peripheral blood. Previous studies have shown that elevated sST2 is highly associated with unfavorable clinical outcomes of patients with ischemia heart diseases and heart failure. This study will further investigate the ability of sST2 to predict unfavorable outcomes for STEMI patients after primary PCI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI patients having primary PCI | – | –Patients with STEMI receiving primary PCI in Wuhan Aisa Heart Hospital are included in this study. All patients are the first time to have STEMI, and primary PCIs are performed according to 2013 ACCF/AHA guideline for the management of STEMI. Patients with previous stroke, pneumonia, cirrhosis, autoimmune diseases are excluded from this study. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese han population in middle China
Key inclusion criteria (1 listed)
- Patients with first onset STEMI receive primary PCI according to 2013 ACCF/AHA guideline for management of STEMI
Key exclusion criteria (1 listed)
- Patients with previous stroke, pneumonia, cirrhosis, autoimmune diseases or severe infection are excluded from this study.
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
stent restenosis
Time frame: one year after primary PCI
Evidence of stent restenosis of the patients receiving primary PCI, confirmed by coronary angiography when patients are readmitted due to the related symptoms.
recurrence of myocardial infarction
Time frame: one year after primary PCI
Evidence of myocardial infarction of the patients receiving primary PCI, confirmed by coronary angiography or ECG when patients are readmitted due to the related symptoms.
heart failure
Time frame: one year after primary PCI
Evidence of heart failure of the patients receiving primary PCI, confirmed by clinical diagnosis when patients are readmitted due to the related symptoms.
cardiac death
Time frame: one year after primary PCI
Evidence of death due to the cardiac dysfunction of the patients receiving primary PCI.
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 2 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Xuan Zheng, MD,PhD principal investigator
Wuhan Asia Heart Hospital
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 Myocardial Infarction and Shock, run by Wuhan Asia Heart Hospital at 1 site in China.
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 1 inclusion and 1 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 2 Oct 2019. 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 China. 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?
stent restenosis (time frame: one year after primary PCI). The study lists 4 primary outcomes in all. 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 2 Oct 2019.