Heart FailureEARLY-HFNCT04810806
Timing of Coronary Angiography in NSTE-ACS With ADHF
A study testing Immediate coronary angiography within 2 hours after randomization and Delayed coronary angiography after stabilization of heart failure in people with Heart Failure and Acute Coronary Syndrome, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
The investigators hypothesized that immediate coronary angiography (CAG) within 2 hours after admission can reduce mortality compared to delayed CAG after stabilization of acute decompensated heart failure (ADHF) in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) complicated by ADHF. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Failure, Acute Coronary Syndrome
- What is being tested?
- Immediate coronary angiography within 2 hours after randomization and Delayed coronary angiography after stabilization of heart failure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2021to 1 Mar 2024
- Phase
- Interventional
- 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
Who may be able to join
- Age more than 18 years old
- NSTE-ACS*
- Pulmonary congestion or edema on chest X-ray
- The definition of NSTE-ACS
- Among patients with typical angina, dyspnea or chest discomfort without definite non-cardiac causes, at least 1 presentations of angina that suggest a NSTE-ACS:
- Rest angina, which is usually more than 20 minutes in duration
Show all 9Show fewer
- New onset angina that markedly limits physical activity
- Increasing angina that is more frequent, longer in duration, or occurs with less exertion than previous angina
- A 12-lead electrocardiogram should have no ST-segment elevation. Cardiac troponin may elevate (non-ST-segment elevation myocardial infarction) or not elevate (unstable angina pectoris).
Who cannot join
- 1) Cardiogenic shock 2) Heart failure of other causes rather than NSTE-ACS 3) Terminal malignancy 4) Life expentancy < 1 year 5) Pregnancy or lactation
- The definition of cardiogenic shock All these criteria should be met
- Systolic blood pressure < 90 mmHg for 30 minutes, or needing inotropics or vasopressor to maintain systolic blood pressure > or = 90 mmHg
- Pulmonary congestion on chest X-ray or increased left ventricular filling pressure by cardiac catheterization
- At least one criteria of organ dysfunction - mental obtundation, clammy ski, ogliuria, renal dysfunction, increased level of blood lactate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Versus Delayed Coronary Angiography in Patients With Non-ST-Segment Acute Coronary Syndrome With Acute Decompensated Heart Failure
The investigators hypothesized that immediate coronary angiography (CAG) within 2 hours after admission can reduce mortality compared to delayed CAG after stabilization of acute decompensated heart failure (ADHF) in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) complicated by ADHF. Patients with NSTE-ACS complicated by ADHF will be randomized to immediate CAG (coronary angiography < 2 hours after randomization) or delayed CAG after stablization group by 1:1 fashion. This study is a prospective, non-blinded, randomized trial.
Read the detailed description
Study objective In this study, investigators aim to compare early coronary angiography (CAG < 2 hours after randomization) and delayed CAG after stabilization of acute decompensated heart failure (ADHF) in patients with acute non-ST-elevation acute coronary syndrome (NSTE-ACS) complicated by ADHF. This study is a prospective, non-blinded, randomized trial.
Study background An ADHF is frequently encountered in patients with NSTE-ACS. Although its incidence has been decreased during the decades, it is still high up to 8-12% at initial presentation of NSTE-ACS. Patients with NSTE-ACS complicated by ADHF is also known to be associated with worse in-hospital and long-term clinical outcomes than those without heart failure (HF). Because revascularization could reduce mortality in these patients, it should be done in all patients with NSTE-ACS with ADHF. Current guidelines recommend immediate CAG within 2 hours after admission in patients with NSTE-ACS complicated by ADHF. However, it is difficult to decide the timing of coronary angiography in these high risk patients.
Notably, the most of randomized trials about the timing of coronary angiography in NSTE-ACS excluded these high risk patients, therefore there is lack of evidence for immediate coronary angiography within 2 hours after admission in patients with NSTE-ACS complicated by ADHF.
Investigators will compare immediate CAG within 2 hours after admission and delayed CAG after stabilization of ADHF in patients with NSTE-ACS complicated by ADHF by randomized controlled trial.
Study hypothesis Immediate CAG within 2 hours after admission can reduce mortality compared to delayed CAG after stabilization of ADHF in patients with NSTE-ACS complicated by ADHF.
- Conditions
- Heart Failure, Acute Coronary Syndrome
- Being tested
- Immediate coronary angiography within 2 hours after randomization, Delayed coronary angiography after stabilization of heart failure
- Keywords
- Heart Failure, Acute Coronary Syndrome, Non-ST-Segment Elevation Acute Coronary Syndrome, Myocardial Infarction, Coronary Disease, Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Heart Failure, Acute Coronary Syndrome, Myocardial Infarction, Coronary Disease, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate coronary angiography within 2 hours after randomizationProcedure or surgery
After achievement of informed consent in patients with NSTE-ACS complicated by ADHF, patients will be screened and randomized. Patients will be randomized to immediate CAG group or delayed CAG group. Immediate CAG group will receive CAG within 2 hours after randomization. Patients will receive treatment methods according to CAG results: percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or medical therapy only by operators' discretion.
Delayed coronary angiography after stabilization of heart failureProcedure or surgery
After achievement of informed consent in patients with NSTE-ACS complicated by ADHF, patients will be screened and randomized. Patients will be randomized to immediate CAG group or delayed CAG group. Delayed CAG group will receive CAG after stabilization of ADHF; improvement of symptoms and signs of heart failure. Patients will receive treatment methods according to CAG results: percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or medical therapy only by operators' discretion.
| Study group | Role | What they receive |
|---|---|---|
| Immediate coronary angiography group | Experimental | Immediate coronary angiography group will routinely receive coronary angiography within 2 hours after randomization. Receives: Procedure: Immediate coronary angiography within 2 hours after randomization |
| Delayed coronary angiography group | Active comparator | Delayed coronary angiography group will receive coronary angiography during hospitalization after stabilization of symptoms and signs of heart failure. Receives: Procedure: Delayed coronary angiography after stabilization of heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia
Measured: Up to 12 months
Secondary outcomes (37)
Rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia
All-cause death, non-fatal myocardial infarction or recurrent ischemia during initial hospitalization
Measured: Up to 12 months
In-hospital mortality
All-cause mortality during initial hospitalization
Measured: Up to 12 months
In-hospital cardiac mortality
Cardiac mortality during initial hospitalization
Measured: Up to 12 months
Rate of procedural complications during coronary angiography or percutaneous coronary intervention
Rate of procedural complications during coronary angiography or percutaneous coronary intervention during initial hospitalization
Measured: Up to 12 months
Peak level of troponin-I
Peak level of troponin-I during initial hospitalization
Measured: Up to 12 months
Rate of recurrent ischemia
Rate of recurrent ischemia during initial hospitalization
Measured: Up to 12 months
Rate of Non-fatal myocardial infarction
Non-fatal myocardial infarction during initial hospitalization
Measured: Up to 12 months
Rate of stroke
Rate of stroke during initial hospitalization
Measured: Up to 12 months
Usage rate of non-invasive positive pressure ventilation
Usage rate of non-invasive positive pressure ventilation during initial hospitalization
Measured: Up to 12 months
Usage rate of mechanical ventilator
Usage rate of mechanical ventilator during initial hospitalization
Measured: Up to 12 months
Usage rate of renal replacement therapy
Usage rate of renal replacement therapy during initial hospitalization
Measured: Up to 12 months
Usage rate of mechanical circulatory support
Usage rate of mechanical circulatory support during initial hospitalization
Measured: Up to 12 months
Rate of acute kidney injury
Rate of acute kidney injury during initial hospitalization
Measured: Up to 12 months
Rate of stent thrombosis
Rate of stent thrombosis during initial hospitalization
Measured: Up to 12 months
Rate of major bleeding
Rate of major bleeding during initial hospitalization (BARC classificiation 3-5)
Measured: Up to 12 months
Duration of initial hospitalization
Duration of initial hospitalization (days)
Measured: Up to 12 months
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia
Measured: Up to 1 month
Cumulative incidence rate of all-cause death
Cumulative incidence rate of all-cause death
Measured: Up to 1 month
Cumulative incidence rate of cardiac death
Cumulative incidence rate of cardiac death
Measured: Up to 1 month
Cumulative incidence rate of rehospitalization due to heart failure
Cumulative incidence rate of rehospitalization due to heart failure
Measured: Up to 1 month
Cumulative incidence rate of cardiogenic shock
Cumulative incidence rate of cardiogenic shock
Measured: Up to 1 month
Cumulative incidence rate of stroke
Cumulative incidence rate of stroke
Measured: Up to 1 month
Cumulative incidence rate of stent thrombosis
Cumulative incidence rate of stent thrombosis
Measured: Up to 1 month
Cumulative incidence rate of major bleeding (BARC classification 3-5)
Cumulative incidence rate of major bleeding (BARC classification 3-5)
Measured: Up to 1 month
Cumulative incidence rate of recurrent ischemia
Cumulative incidence rate of recurrent ischemia
Measured: Up to 1 month
Cumulative incidence rate of non-fatal myocardial infarction
Cumulative incidence rate of non-fatal myocardial infarction
Measured: Up to 1 month
Cumulative incidence rate of all unplanned revascularization
Cumulative incidence rate of all unplanned revascularization
Measured: Up to 1 month
Cumulative incidence rate of all-cause death
Cumulative incidence rate of all-cause death
Measured: Up to 12 months
Cumulative incidence rate of cardiac death
Cumulative incidence rate of cardiac death
Measured: Up to 12 months
Cumulative incidence rate of rehospitalization due to heart failure
Cumulative incidence rate of rehospitalization due to heart failure
Measured: Up to 12 months
Cumulative incidence rate of cardiogenic shock
Cumulative incidence rate of cardiogenic shock
Measured: Up to 12 months
Cumulative incidence rate of stroke
Cumulative incidence rate of stroke
Measured: Up to 12 months
Cumulative incidence rate of stent thrombosis
Cumulative incidence rate of stent thrombosis
Measured: Up to 12 months
Cumulative incidence rate of major bleeding (BARC classification 3-5)
Cumulative incidence rate of major bleeding (BARC classification 3-5)
Measured: Up to 12 months
Cumulative incidence rate of recurrent ischemia
Cumulative incidence rate of recurrent ischemia
Measured: Up to 12 months
Cumulative incidence rate of non-fatal myocardial infarction
Cumulative incidence rate of non-fatal myocardial infarction
Measured: Up to 12 months
Cumulative incidence rate of all unplanned revascularization
Cumulative incidence rate of all unplanned revascularization
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Apr 2021
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Why it stopped: Slow enrollment
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 Heart FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Chul Kim, Chonnam National University Hospital
- Investigators
- Min Chul Kim, Professor, Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810806
- Sponsor's protocol ID
- CNUH-2020-396
- Acronym
- EARLY-HF
- Status last verified
- Feb 2024
- First submitted
- 14 Mar 2021
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lim Y, Park S, Joo D, Lee YK, Oh S, Lee SH, Ahn JH, Hyun DY, Cho KH, Sim DS, Hong YJ, Kim JH, Ahn Y, Kim MC. Immediate versus delayed coronary angiography in patients with non-ST segment elevation acute coronary syndrome complicated with acute decompensated heart failure: The EARLY-HF randomized clinical trial. Cardiovasc Revasc Med. 2026 Feb;83:32-39. doi: 10.1016/j.carrev.2025.09.016. Epub 2025 Oct 6.
PubMed 41073186
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Versus Delayed Coronary Angiography in Patients With Non-ST-Segment Acute Coronary Syndrome With Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT04810806
- Acronym / sponsor ID
- EARLY-HF / CNUH-2020-396
- Conditions
- Heart Failure, Acute Coronary Syndrome
- Keywords
- Heart Failure, Acute Coronary Syndrome, Non-ST-Segment Elevation Acute Coronary Syndrome, Myocardial Infarction, Coronary Disease, Cardiovascular Diseases, Heart Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 23 Mar 2021 (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.
The investigators hypothesized that immediate coronary angiography (CAG) within 2 hours after admission can reduce mortality compared to delayed CAG after stabilization of acute decompensated heart failure (ADHF) in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) complicated by ADHF. Patients with NSTE-ACS complicated by ADHF will be randomized to immediate CAG (coronary angiography < 2 hours after randomization) or delayed CAG after stablization group by 1:1 fashion. This study is a prospective, non-blinded, randomized trial.
Detailed description
Study objective In this study, investigators aim to compare early coronary angiography (CAG < 2 hours after randomization) and delayed CAG after stabilization of acute decompensated heart failure (ADHF) in patients with acute non-ST-elevation acute coronary syndrome (NSTE-ACS) complicated by ADHF. This study is a prospective, non-blinded, randomized trial.
Study background An ADHF is frequently encountered in patients with NSTE-ACS. Although its incidence has been decreased during the decades, it is still high up to 8-12% at initial presentation of NSTE-ACS. Patients with NSTE-ACS complicated by ADHF is also known to be associated with worse in-hospital and long-term clinical outcomes than those without heart failure (HF). Because revascularization could reduce mortality in these patients, it should be done in all patients with NSTE-ACS with ADHF. Current guidelines recommend immediate CAG within 2 hours after admission in patients with NSTE-ACS complicated by ADHF. However, it is difficult to decide the timing of coronary angiography in these high risk patients.
Notably, the most of randomized trials about the timing of coronary angiography in NSTE-ACS excluded these high risk patients, therefore there is lack of evidence for immediate coronary angiography within 2 hours after admission in patients with NSTE-ACS complicated by ADHF.
Investigators will compare immediate CAG within 2 hours after admission and delayed CAG after stabilization of ADHF in patients with NSTE-ACS complicated by ADHF by randomized controlled trial.
Study hypothesis Immediate CAG within 2 hours after admission can reduce mortality compared to delayed CAG after stabilization of ADHF in patients with NSTE-ACS complicated by ADHF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate coronary angiography group | Experimental | Procedure: Immediate coronary angiography within 2 hours after randomizationImmediate coronary angiography group will routinely receive coronary angiography within 2 hours after randomization. |
| Delayed coronary angiography group | Active comparator | Procedure: Delayed coronary angiography after stabilization of heart failureDelayed coronary angiography group will receive coronary angiography during hospitalization after stabilization of symptoms and signs of heart failure. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age more than 18 years old
- NSTE-ACS*
- Pulmonary congestion or edema on chest X-ray
- Among patients with typical angina, dyspnea or chest discomfort without definite non-cardiac causes, at least 1 presentations of angina that suggest a NSTE-ACS:
- Rest angina, which is usually more than 20 minutes in duration
Key exclusion criteria (5 listed)
- 1) Cardiogenic shock 2) Heart failure of other causes rather than NSTE-ACS 3) Terminal malignancy 4) Life expentancy < 1 year 5) Pregnancy or lactation
- The definition of cardiogenic shock All these criteria should be met
- Systolic blood pressure < 90 mmHg for 30 minutes, or needing inotropics or vasopressor to maintain systolic blood pressure > or = 90 mmHg
- Pulmonary congestion on chest X-ray or increased left ventricular filling pressure by cardiac catheterization
- At least one criteria of organ dysfunction - mental obtundation, clammy ski, ogliuria, renal dysfunction, increased level of blood lactate
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 |
|---|---|---|
| Immediate coronary angiography within 2 hours after randomizationAfter achievement of informed consent in patients with NSTE-ACS complicated by ADHF, patients will be screened and randomized. Patients will be randomized to immediate CAG group or delayed CAG group. Immediate CAG group will receive CAG within 2 hours after randomization. Patients will receive treatment methods according to CAG results: percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or medical therapy only by operators' discretion. | Procedure or surgery | Immediate coronary angiography group |
| Delayed coronary angiography after stabilization of heart failureAfter achievement of informed consent in patients with NSTE-ACS complicated by ADHF, patients will be screened and randomized. Patients will be randomized to immediate CAG group or delayed CAG group. Delayed CAG group will receive CAG after stabilization of ADHF; improvement of symptoms and signs of heart failure. Patients will receive treatment methods according to CAG results: percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or medical therapy only by operators' discretion. | Procedure or surgery | Delayed coronary angiography group |
Primary outcome
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia
Time frame: Up to 12 months
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia
37 secondary outcomes
Rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia
Time frame: Up to 12 months
In-hospital mortality
Time frame: Up to 12 months
In-hospital cardiac mortality
Time frame: Up to 12 months
Rate of procedural complications during coronary angiography or percutaneous coronary intervention
Time frame: Up to 12 months
Peak level of troponin-I
Time frame: Up to 12 months
Rate of recurrent ischemia
Time frame: Up to 12 months
Rate of Non-fatal myocardial infarction
Time frame: Up to 12 months
Rate of stroke
Time frame: Up to 12 months
Usage rate of non-invasive positive pressure ventilation
Time frame: Up to 12 months
Usage rate of mechanical ventilator
Time frame: Up to 12 months
Usage rate of renal replacement therapy
Time frame: Up to 12 months
Usage rate of mechanical circulatory support
Time frame: Up to 12 months
Rate of acute kidney injury
Time frame: Up to 12 months
Rate of stent thrombosis
Time frame: Up to 12 months
Rate of major bleeding
Time frame: Up to 12 months
Duration of initial hospitalization
Time frame: Up to 12 months
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia
Time frame: Up to 1 month
Cumulative incidence rate of all-cause death
Time frame: Up to 1 month
Cumulative incidence rate of cardiac death
Time frame: Up to 1 month
Cumulative incidence rate of rehospitalization due to heart failure
Time frame: Up to 1 month
Cumulative incidence rate of cardiogenic shock
Time frame: Up to 1 month
Cumulative incidence rate of stroke
Time frame: Up to 1 month
Cumulative incidence rate of stent thrombosis
Time frame: Up to 1 month
Cumulative incidence rate of major bleeding (BARC classification 3-5)
Time frame: Up to 1 month
Cumulative incidence rate of recurrent ischemia
Time frame: Up to 1 month
Cumulative incidence rate of non-fatal myocardial infarction
Time frame: Up to 1 month
Cumulative incidence rate of all unplanned revascularization
Time frame: Up to 1 month
Cumulative incidence rate of all-cause death
Time frame: Up to 12 months
Cumulative incidence rate of cardiac death
Time frame: Up to 12 months
Cumulative incidence rate of rehospitalization due to heart failure
Time frame: Up to 12 months
Cumulative incidence rate of cardiogenic shock
Time frame: Up to 12 months
Cumulative incidence rate of stroke
Time frame: Up to 12 months
Cumulative incidence rate of stent thrombosis
Time frame: Up to 12 months
Cumulative incidence rate of major bleeding (BARC classification 3-5)
Time frame: Up to 12 months
Cumulative incidence rate of recurrent ischemia
Time frame: Up to 12 months
Cumulative incidence rate of non-fatal myocardial infarction
Time frame: Up to 12 months
Cumulative incidence rate of all unplanned revascularization
Time frame: Up to 12 months
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Derived from this study: PubMed 41073186Lim Y, Park S, Joo D, Lee YK, Oh S, Lee SH, Ahn JH, Hyun DY, Cho KH, Sim DS, Hong YJ, Kim JH, Ahn Y, Kim MC. Immediate versus delayed coronary angiography in patients with non-ST segment elevation acute coronary syndrome complicated with acute decompensated heart failure: The EARLY-HF randomized clinical trial. Cardiovasc Revasc Med. 2026 Feb;83:32-39. doi: 10.1016/j.carrev.2025.09.016. Epub 2025 Oct 6.
- 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.
Min Chul Kim, Professor principal investigator
Chonnam National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate coronary angiography within 2 hours after randomization and Delayed coronary angiography after stabilization of heart failure in people with Heart Failure and Acute Coronary Syndrome, run by Chonnam National University Hospital 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 9 inclusion and 5 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: stopped early, as of the sponsor's last update on 1 Mar 2024. 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 was stopped early (reason given: Slow enrollment). Results are not available in the source record.
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?
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia (time frame: Up to 12 months). 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 NCT04810806, 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 1 Mar 2024.