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Immediate Versus Delayed Coronary Angiography in Patients With Non-ST-Segment Acute Coronary Syndrome with Acute Decompensated Heart Failure

Status Approved

  • First Submitted Date

    2021/03/14

  • Registered Date

    2021/03/29

  • Last Updated Date

    2024/02/29

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number    		 KCT0006035
    Unique Protocol ID CNUH-2020-396
    Public/Brief Title Immediate Versus Delayed Coronary Angiography in Patients With Non-ST-Segment Acute Coronary Syndrome with Acute Decompensated Heart Failure
    Scientific Title Immediate Versus Delayed Coronary Angiography in Patients With Non-ST-Segment Acute Coronary Syndrome with Acute Decompensated Heart Failure
    Acronym EARLY-HF
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable

  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number CNUH-2020-396
    Approval Date 2021-01-11
    Institutional Review Board Name Chonnam National University Hospital Institutional Review Board
    Institutional Review Board Address 42 Jebong-ro, Dong-gu, Gwangju, Korea 61469
    Institutional Review Board Telephone 062-220-5257
    Data Monitoring Committee No

  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Min Chul Kim
    Title Associate Professor
    Telephone +82-62-220-6578
    Affiliation Chonnam National University Hospital
    Address Jebong-ro 42, Dong-gu, Gwangju, Korea
    Contact Person for Public Queries
    Name Min Chul Kim
    Title Associate Professor
    Telephone +82-62-220-6578
    Affiliation Chonnam National University Hospital
    Address Jebong-ro 42, Dong-gu, Gwangju, Korea
    Contact Person for Updating Information
    Name Min Chul Kim
    Title Associate Professor
    Telephone +82-62-220-6578
    Affiliation Chonnam National University Hospital
    Address Jebong-ro 42, Dong-gu, Gwangju, Korea

  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Terminated
    Date of First Enrollment 2021-04-01 Actual
    Target Number of Participant 316
    Primary Completion Date 2024-08-31 , Anticipated
    Study Completion Date 2025-08-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Chonnam National University Hospital
    Recruitment Status Terminated Terminated Reason : 환자 등록 어려움
    Date of First Enrollment 2021-04-01 ,

  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Chonnam National University Hospital
    Organization Type Medical Institute
    Project ID CNUH-2020-396

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Chonnam National University Hospital
    Organization Type Medical Institute

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    Study objective
In this study, investigators aim to compare early coronary angiography (CAG < 2 hours after admission) 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.

  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose 
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type /Procedure/Surgery  
    Intervention Description 
    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. Delayed CAG group will receive CAG after stabilization of ADHF; improvement of symptoms and signs of HF. 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.
    Number of Arms 2
    Arm 1

    Arm Label

    Immediate coronary angiography group

    Target Number of Participant

    158

    Arm Type

    Experimental

    Arm Description

    Immediate coronary angiography group will routinely receive coronary angiography within 2 hours after randomization.
    Arm 2

    Arm Label

    Delayed coronary angiography group

    Target Number of Participant

    158

    Arm Type

    Active comparator

    Arm Description

    Delayed coronary angiography group will receive coronary angiography during hospitalization after stabilization of symptoms and signs of heart failure.

  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (I00-I99)Diseases of the circulatory system 
       (I50.9)Heart failure, unspecified 

    Heart failure Acute coronary syndrome
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~No Limit

    Description

    1) Age more than 18 years old
2) NSTE-ACS*
3) 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 an NSTE-ACS:
1) Rest angina, which is usually more than 20 minutes in duration
2) New onset angina that markedly limits physical activity
3) 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).
    Exclusion Criteria 
    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
1) Systolic blood pressure < 90 mmHg for 30 minutes, or needing inotropics or vasopressor to maintain systolic blood pressure > or = 90 mmHg
2) Pulmonary congestion on chest X-ray or increased left ventricular filling pressure by cardiac catheterization
3) At least one criteria of organ dysfunction
- mental obtundation, clammy ski, ogliuria, renal dysfunction, increased level of blood lactate
    Healthy Volunteers No

  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome 
    Death, non-fatal myocardial infarction or recurrent ischemia
    Timepoint 
    At 12 months post-randomization
    Secondary Outcome(s) 1
    Outcome 
    Death, non-fatal myocardial infarction or recurrent ischemia
    Timepoint 
    During initial hospitalization
    Secondary Outcome(s) 2
    Outcome 
    All-cause death
    Timepoint 
    During initial hospitalization
    Secondary Outcome(s) 3
    Outcome 
    Cardiac death
    Timepoint 
    During initial hospitalization
    Secondary Outcome(s) 4
    Outcome 
    Peak level of troponin-I
    Timepoint 
    During initial hospitalization
    Secondary Outcome(s) 5
    Outcome 
    Procedural complications during coronary angiography or percutaneous coronary intervention
    Timepoint 
    During initial hospitalization
    Secondary Outcome(s) 6
    Outcome 
    Recurrent ischemia
    Timepoint 
    During initial hospitalization
    Secondary Outcome(s) 7
    Outcome 
    Non-fatal myocardial infarction
    Timepoint 
    During initial hospitalization
    Secondary Outcome(s) 8
    Outcome 
    Stroke
    Timepoint 
    During initial hospitalization
    Secondary Outcome(s) 9
    Outcome 
    Use of non-invasive positive pressure ventilation
    Timepoint 
    During initial hospitalization
    Secondary Outcome(s) 10
    Outcome 
    Use of mechanical ventilator
    Timepoint 
    During initial hospitalization
    Secondary Outcome(s) 11
    Outcome 
    Continuous renal replacement therapy or conventional hemodialysis
    Timepoint 
    During initial hospitalization
    Secondary Outcome(s) 12
    Outcome 
    Use of mechanical circulatory support
    Timepoint 
    During initial hospitalization
    Secondary Outcome(s) 13
    Outcome 
    Acute kidney injury
    Timepoint 
    During initial hospitalization
    Secondary Outcome(s) 14
    Outcome 
    Stent thrombosis
    Timepoint 
    During initial hospitalization
    Secondary Outcome(s) 15
    Outcome 
    Major bleeding (BARC 3-5)
    Timepoint 
    During initial hospitalization
    Secondary Outcome(s) 16
    Outcome 
    Duration of hospitalization
    Timepoint 
    During initial hospitalization
    Secondary Outcome(s) 17
    Outcome 
    Death, non-fatal myocardial infarction or recurrent ischemia
    Timepoint 
    At 1 month post-randomization
    Secondary Outcome(s) 18
    Outcome 
    All-cause death
    Timepoint 
    At 1 month post-randomization
    Secondary Outcome(s) 19
    Outcome 
    Cardiac death
    Timepoint 
    At 1 month post-randomization
    Secondary Outcome(s) 20
    Outcome 
    Re-hospitalization due to heart failure
    Timepoint 
    At 1 month post-randomization
    Secondary Outcome(s) 21
    Outcome 
    Cardiogenic shock
    Timepoint 
    At 1 month post-randomization
    Secondary Outcome(s) 22
    Outcome 
    Stroke
    Timepoint 
    At 1 month post-randomization
    Secondary Outcome(s) 23
    Outcome 
    Stent thrombosis
    Timepoint 
    At 1 month post-randomization
    Secondary Outcome(s) 24
    Outcome 
    Major bleeding (BARC 3-5)
    Timepoint 
    At 1 month post-randomization
    Secondary Outcome(s) 25
    Outcome 
    Recurrent ischemia
    Timepoint 
    At 1 month post-randomization
    Secondary Outcome(s) 26
    Outcome 
    Non-fatal myocardial infarction
    Timepoint 
    At 1 month post-randomization
    Secondary Outcome(s) 27
    Outcome 
    All unplanned revascularization
    Timepoint 
    At 1 month post-randomization
    Secondary Outcome(s) 28
    Outcome 
    All-cause death
    Timepoint 
    At 12 months post-randomization
    Secondary Outcome(s) 29
    Outcome 
    Cardiac death
    Timepoint 
    At 12 months post-randomization
    Secondary Outcome(s) 30
    Outcome 
    Re-hospitalization due to heart failure
    Timepoint 
    At 12 months post-randomization
    Secondary Outcome(s) 31
    Outcome 
    Cardiogenic shock
    Timepoint 
    At 12 months post-randomization
    Secondary Outcome(s) 32
    Outcome 
    Stroke
    Timepoint 
    At 12 months post-randomization
    Secondary Outcome(s) 33
    Outcome 
    Stent thrombosis
    Timepoint 
    At 12 months post-randomization
    Secondary Outcome(s) 34
    Outcome 
    Major bleeding (BARC 3-5)
    Timepoint 
    At 12 months post-randomization
    Secondary Outcome(s) 35
    Outcome 
    Recurrent ischemia
    Timepoint 
    At 12 months post-randomization
    Secondary Outcome(s) 36
    Outcome 
    Non-fatal myocardial infarction
    Timepoint 
    At 12 months post-randomization
    Secondary Outcome(s) 37
    Outcome 
    All unplanned revascularization
    Timepoint 
    At 12 months post-randomization

  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No

  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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