NCT04810806

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

2.9 years

First QC Date

March 14, 2021

Last Update Submit

February 29, 2024

Conditions

Heart FailureAcute Coronary Syndrome

Keywords

Heart FailureAcute Coronary SyndromeNon-ST-Segment Elevation Acute Coronary SyndromeMyocardial InfarctionCoronary DiseaseCardiovascular DiseasesHeart Diseases

Outcome Measures

Primary Outcomes (1)

  • 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

    Up to 12 months

Secondary Outcomes (37)

  • Rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia

    Up to 12 months

  • In-hospital mortality

    Up to 12 months

  • In-hospital cardiac mortality

    Up to 12 months

  • Rate of procedural complications during coronary angiography or percutaneous coronary intervention

    Up to 12 months

  • Peak level of troponin-I

    Up to 12 months

  • +32 more secondary outcomes

Study Arms (2)

Immediate coronary angiography group

EXPERIMENTAL

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

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.

Procedure: Delayed coronary angiography after stabilization of heart failure

Interventions

Immediate coronary angiography within 2 hours after randomizationPROCEDURE

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.

Immediate coronary angiography group
Delayed coronary angiography after stabilization of heart failurePROCEDURE

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.

Delayed coronary angiography group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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).

You may not qualify if:

  • \) 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonnam National University Hospital

Gwangju, South Korea

Location

Related Publications (1)

  • 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. 2025 Oct 6:S1553-8389(25)00509-3. doi: 10.1016/j.carrev.2025.09.016. Online ahead of print.

    PMID: 41073186DERIVED

MeSH Terms

Conditions

Heart FailureAcute Coronary SyndromeMyocardial InfarctionCoronary DiseaseCardiovascular DiseasesHeart Diseases

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Min Chul Kim, Professor

    Chonnam National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 14, 2021

First Posted

March 23, 2021

Study Start

April 1, 2021

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

March 1, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)