Acute Coronary Syndrome, Heart Failure
Conditions
Keywords
Heart Failure, Acute Coronary Syndrome, Non-ST-Segment Elevation Acute Coronary Syndrome, Myocardial Infarction, Coronary Disease, Cardiovascular Diseases, Heart Diseases
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.
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.
Interventions
PROCEDUREImmediate coronary angiography within 2 hours after randomization
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.
PROCEDUREDelayed coronary angiography after stabilization of heart failure
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.
Sponsors
Chonnam National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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 a 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia | Up to 12 months | Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital mortality | Up to 12 months | All-cause mortality during initial hospitalization |
| In-hospital cardiac mortality | Up to 12 months | Cardiac mortality during initial hospitalization |
| Rate of procedural complications during coronary angiography or percutaneous coronary intervention | Up to 12 months | Rate of procedural complications during coronary angiography or percutaneous coronary intervention during initial hospitalization |
| Peak level of troponin-I | Up to 12 months | Peak level of troponin-I during initial hospitalization |
| Rate of recurrent ischemia | Up to 12 months | Rate of recurrent ischemia during initial hospitalization |
| Rate of Non-fatal myocardial infarction | Up to 12 months | Non-fatal myocardial infarction during initial hospitalization |
| Rate of stroke | Up to 12 months | Rate of stroke during initial hospitalization |
| Usage rate of non-invasive positive pressure ventilation | Up to 12 months | Usage rate of non-invasive positive pressure ventilation during initial hospitalization |
| Usage rate of mechanical ventilator | Up to 12 months | Usage rate of mechanical ventilator during initial hospitalization |
| Usage rate of renal replacement therapy | Up to 12 months | Usage rate of renal replacement therapy during initial hospitalization |
| Usage rate of mechanical circulatory support | Up to 12 months | Usage rate of mechanical circulatory support during initial hospitalization |
| Rate of acute kidney injury | Up to 12 months | Rate of acute kidney injury during initial hospitalization |
| Rate of stent thrombosis | Up to 12 months | Rate of stent thrombosis during initial hospitalization |
| Rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia | Up to 12 months | All-cause death, non-fatal myocardial infarction or recurrent ischemia during initial hospitalization |
| Duration of initial hospitalization | Up to 12 months | Duration of initial hospitalization (days) |
| Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia | Up to 1 month | Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia |
| Cumulative incidence rate of all-cause death | Up to 1 month | Cumulative incidence rate of all-cause death |
| Cumulative incidence rate of cardiac death | Up to 1 month | Cumulative incidence rate of cardiac death |
| Cumulative incidence rate of rehospitalization due to heart failure | Up to 1 month | Cumulative incidence rate of rehospitalization due to heart failure |
| Cumulative incidence rate of cardiogenic shock | Up to 1 month | Cumulative incidence rate of cardiogenic shock |
| Cumulative incidence rate of stroke | Up to 1 month | Cumulative incidence rate of stroke |
| Cumulative incidence rate of stent thrombosis | Up to 1 month | Cumulative incidence rate of stent thrombosis |
| Cumulative incidence rate of major bleeding (BARC classification 3-5) | Up to 1 month | Cumulative incidence rate of major bleeding (BARC classification 3-5) |
| Cumulative incidence rate of recurrent ischemia | Up to 1 month | Cumulative incidence rate of recurrent ischemia |
| Cumulative incidence rate of non-fatal myocardial infarction | Up to 1 month | Cumulative incidence rate of non-fatal myocardial infarction |
| Cumulative incidence rate of all unplanned revascularization | Up to 1 month | Cumulative incidence rate of all unplanned revascularization |
| Rate of major bleeding | Up to 12 months | Rate of major bleeding during initial hospitalization (BARC classificiation 3-5) |
Countries
South Korea
Outcome results
None listed