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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006035

Enrollment

316

Registered

2021-03-29

Start date

2021-04-01

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/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

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 ther

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 1) Cardiogenic shock* 2) Heart failure of other causes rather than NSTE-ACS 3) Terminal malignancy 4) Life expentancy 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

Design outcomes

Primary

Measure	Time frame
Death, non-fatal myocardial infarction or recurrent ischemia	—

Secondary

Measure	Time frame
Death, non-fatal myocardial infarction or recurrent ischemia;All-cause death;Cardiac death;Peak level of troponin-I;Procedural complications during coronary angiography or percutaneous coronary intervention;Recurrent ischemia;Non-fatal myocardial infarction;Stroke;Use of non-invasive positive pressure ventilation;Use of mechanical ventilator;Continuous renal replacement therapy or conventional hemodialysis;Use of mechanical circulatory support;Acute kidney injury;Stent thrombosis;Major bleeding (BARC 3-5);Duration of hospitalization;Death, non-fatal myocardial infarction or recurrent ischemia;All-cause death;Cardiac death;Re-hospitalization due to heart failure;Cardiogenic shock;Stroke;Stent thrombosis;Major bleeding (BARC 3-5);Recurrent ischemia;Non-fatal myocardial infarction;All unplanned revascularization;All-cause death;Cardiac death;Re-hospitalization due to heart failure;Cardiogenic shock;Stroke;Stent thrombosis;Major bleeding (BARC 3-5);Recurrent ischemia;Non-fatal myocardial infarction;All unplanned revascularization	—

Measure

Time frame

Death, non-fatal myocardial infarction or recurrent ischemia;All-cause death;Cardiac death;Peak level of troponin-I;Procedural complications during coronary angiography or percutaneous coronary intervention;Recurrent ischemia;Non-fatal myocardial infarction;Stroke;Use of non-invasive positive pressure ventilation;Use of mechanical ventilator;Continuous renal replacement therapy or conventional hemodialysis;Use of mechanical circulatory support;Acute kidney injury;Stent thrombosis;Major bleeding (BARC 3-5);Duration of hospitalization;Death, non-fatal myocardial infarction or recurrent ischemia;All-cause death;Cardiac death;Re-hospitalization due to heart failure;Cardiogenic shock;Stroke;Stent thrombosis;Major bleeding (BARC 3-5);Recurrent ischemia;Non-fatal myocardial infarction;All unplanned revascularization;All-cause death;Cardiac death;Re-hospitalization due to heart failure;Cardiogenic shock;Stroke;Stent thrombosis;Major bleeding (BARC 3-5);Recurrent ischemia;Non-fatal myocardial infarction;All unplanned revascularization

—

Countries

Korea, Republic of

Contacts

Public ContactMin Chul Kim

Chonnam National University Hospital

kmc3242@hanmail.net+82-62-220-6578

Outcome results