Myocardial InfarctionNCT02804958
Incheon-Bucheon Cohort of Patients Undergoing Primary PCI for Acute STEMI
An observational study of Myocardial Infarction, run by Gachon University Gil Medical Center at 4 sites in South Korea.
Trial summary
INcheon-Bucheon cohorT of patients undERgoing primary percutaneous coronary intervention for acute ST-ELevation myocardiaL infARction (INTERSTELLAR) registry is a retrospective, observational, 4-regional-hospital based registry reflecting current practices of management, risk factors, and clinical outcomes in patients… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- STEMI treated with primary PCI
- Type of treatment
- Surgery or procedure
- How many people
- 1,537 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Dec 2014to Dec 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with acute ST-segment elevation myocardial infarction (STEMI) and treated with primary percutaneous coronary intervention (PCI) were consecutively registered. Diagnosis of acute STEMI was based on clinical data findings including typical symptoms, 12-lead electrocardiography, and blood test. Decisions regarding primary PCI were made by at least 2 attending cardiologists at the time of presentation.
Who may be able to join
- Patients diagnosed with acute ST-segment elevation myocardial infarction
- Patients treated with primary percutaneous coronary intervention
Who cannot join
- Patients diagnosed with Non-ST-segment elevation acute coronary syndrome
- Patients treated with thrombolytic therapy
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Sejong General Hospital
Bucheon-si
Soon Chun Hyang University Bucheon Hospital
Bucheon-si
Gachon University Gil Medical Center
Incheon
Inha University Hospital
Incheon
About this study
Official title: Incheon-Bucheon Cohort of Patients Undergoing Primary Percutaneous Coronary Intervention for Acute ST-segment Elevation Myocardial Infarction
INcheon-Bucheon cohorT of patients undERgoing primary percutaneous coronary intervention for acute ST-ELevation myocardiaL infARction (INTERSTELLAR) registry is a retrospective, observational, 4-regional-hospital based registry reflecting current practices of management, risk factors, and clinical outcomes in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention at cities of Incheon and Bucheon located in the mid-western part of the Korean peninsula between 2007 and 2014.
Read the detailed description
INcheon-Bucheon cohorT of patients undERgoing primary percutaneous coronary intervention for acute ST-ELevation myocardiaL infARction (INTERSTELLAR) registry is a retrospective, observational, 4-regional-hospital based registry reflecting current practices of management, risk factors, and clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) at cities of Incheon and Bucheon located in the mid-western part of the Korean peninsula between 2007 and 2014. Diagnosis of acute STEMI was based on clinical data findings including typical symptoms, 12-lead electrocardiography, and blood test. Decisions regarding primary PCI were made by at least 2 attending cardiologists at the time of presentation.
Demographic data, cardiovascular risk factors, laboratory data and clinical follow-up data were collected. Baseline blood test was obtained and recorded as part of the routine care for patients who visited the emergency room for chest pain and in whom acute coronary syndrome was suspected. Standard medical management was provided by responsible physicians.
- Conditions
- Myocardial Infarction
- Being tested
- STEMI treated with primary PCI
- Keywords
- ST-segment elevation myocardial infarction, Primary percutaneous coronary intervention, Clinical outcomes
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEMI treated with primary PCIProcedure or surgery
Primary percutaneous coronary intervention was performed according to the current standard guidelines. Coronary angiography was performed using standard techniques. The use of thrombectomy devices, intravascular ultrasound, intra-aortic balloon pump, and percutaneous cardiopulmonary support was up to the operator.
| Study group | Role | What they receive |
|---|---|---|
| STEMI treated with primary PCI | Patients diagnosed with acute ST-segment elevation myocardial infarction and treated with primary percutaneous coronary intervention were consecutively registered. Receives: Procedure: STEMI treated with primary PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE
Major adverse cardiac and cerebrovascular event (MACCE), defined as the composite of all-cause death, non-fatal myocardial infarction and non-fatal stroke
Measured: Within the 1 year
Secondary outcomes (5)
All-cause death
Measured: Within the 1 year
Non-fatal myocardial infarction
Measured: Within the 1 year
Non-fatal stroke
Measured: Within the 1 year
Ischemic-driven revascularization
Measured: Within the 1 year
Admission for heart failure
Measured: Within the 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Retrospective
- Enrolment
- 1,537 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Soon Chun Hyang University, Sejong General Hospital, Inha University Hospital
- Responsible party
- Principal investigator, Woong Chol Kang, Gachon University Gil Medical Center
- Investigators
- Woong Chol Kang, MD, Principal investigator, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804958
- Sponsor's protocol ID
- INTERSTELLAR
- Status last verified
- Jun 2016
- First submitted
- 15 Jun 2016
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kong MG, Suh J, Lee B, Park HW, Park SY, Moon I, Choi HO, Seo HS, Cho YH, Lee NH, Jang HJ, Kim TH, Kwon SW, Park SD, Oh PC, Moon J, Lee K, Kang WC. Hemo-metabolic impairment in patients with ST-segment elevation myocardial infarction: Data from the INTERSTELLAR registry. Cardiol J. 2024;31(3):434-441. doi: 10.5603/cj.93926. Epub 2023 Nov 15.
PubMed 37964646
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incheon-Bucheon Cohort of Patients Undergoing Primary Percutaneous Coronary Intervention for Acute ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02804958
- Acronym / sponsor ID
- INTERSTELLAR
- Conditions
- Myocardial Infarction
- Keywords
- ST-segment elevation myocardial infarction, Primary percutaneous coronary intervention, Clinical outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,537 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Collaborators
- Soon Chun Hyang University, Sejong General Hospital, Inha University Hospital
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Jun 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.
INcheon-Bucheon cohorT of patients undERgoing primary percutaneous coronary intervention for acute ST-ELevation myocardiaL infARction (INTERSTELLAR) registry is a retrospective, observational, 4-regional-hospital based registry reflecting current practices of management, risk factors, and clinical outcomes in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention at cities of Incheon and Bucheon located in the mid-western part of the Korean peninsula between 2007 and 2014.
Detailed description
INcheon-Bucheon cohorT of patients undERgoing primary percutaneous coronary intervention for acute ST-ELevation myocardiaL infARction (INTERSTELLAR) registry is a retrospective, observational, 4-regional-hospital based registry reflecting current practices of management, risk factors, and clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) at cities of Incheon and Bucheon located in the mid-western part of the Korean peninsula between 2007 and 2014. Diagnosis of acute STEMI was based on clinical data findings including typical symptoms, 12-lead electrocardiography, and blood test. Decisions regarding primary PCI were made by at least 2 attending cardiologists at the time of presentation.
Demographic data, cardiovascular risk factors, laboratory data and clinical follow-up data were collected. Baseline blood test was obtained and recorded as part of the routine care for patients who visited the emergency room for chest pain and in whom acute coronary syndrome was suspected. Standard medical management was provided by responsible physicians.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI treated with primary PCI | – | Procedure: STEMI treated with primary PCIPatients diagnosed with acute ST-segment elevation myocardial infarction and treated with primary percutaneous coronary intervention were consecutively registered. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with acute ST-segment elevation myocardial infarction (STEMI) and treated with primary percutaneous coronary intervention (PCI) were consecutively registered. Diagnosis of acute STEMI was based on clinical data findings including typical symptoms, 12-lead electrocardiography, and blood test. Decisions regarding primary PCI were made by at least 2 attending cardiologists at the time of presentation.
Key inclusion criteria (2 listed)
- Patients diagnosed with acute ST-segment elevation myocardial infarction
- Patients treated with primary percutaneous coronary intervention
Key exclusion criteria (2 listed)
- Patients diagnosed with Non-ST-segment elevation acute coronary syndrome
- Patients treated with thrombolytic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STEMI treated with primary PCIPrimary percutaneous coronary intervention was performed according to the current standard guidelines. Coronary angiography was performed using standard techniques. The use of thrombectomy devices, intravascular ultrasound, intra-aortic balloon pump, and percutaneous cardiopulmonary support was up to the operator. | Procedure or surgery | STEMI treated with primary PCI |
Primary outcome
MACCE
Time frame: Within the 1 year
Major adverse cardiac and cerebrovascular event (MACCE), defined as the composite of all-cause death, non-fatal myocardial infarction and non-fatal stroke
5 secondary outcomes
All-cause death
Time frame: Within the 1 year
Non-fatal myocardial infarction
Time frame: Within the 1 year
Non-fatal stroke
Time frame: Within the 1 year
Ischemic-driven revascularization
Time frame: Within the 1 year
Admission for heart failure
Time frame: Within the 1 year
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 17 Jun 2016.
- Derived from this study: PubMed 37964646Kong MG, Suh J, Lee B, Park HW, Park SY, Moon I, Choi HO, Seo HS, Cho YH, Lee NH, Jang HJ, Kim TH, Kwon SW, Park SD, Oh PC, Moon J, Lee K, Kang WC. Hemo-metabolic impairment in patients with ST-segment elevation myocardial infarction: Data from the INTERSTELLAR registry. Cardiol J. 2024;31(3):434-441. doi: 10.5603/cj.93926. Epub 2023 Nov 15.
- 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.
Woong Chol Kang, MD principal investigator
Gachon University Gil Medical Center
4 sites 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, run by Gachon University Gil Medical Center at 4 sites 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 2 inclusion and 2 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 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
MACCE (time frame: Within the 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02804958, which also lists 1 linked publication.
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 17 Jun 2016.