Timing of Coronary Angiography in NSTE-ACS With ADHF
- Conditions
- Acute Coronary SyndromeHeart Failure
- Interventions
- Procedure: Immediate coronary angiography within 2 hours after randomizationProcedure: Delayed coronary angiography after stabilization of heart failure
- Registration Number
- NCT04810806
- Lead Sponsor
- Chonnam National University Hospital
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 316
-
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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immediate coronary angiography group Immediate coronary angiography within 2 hours after randomization Immediate coronary angiography group will routinely receive coronary angiography within 2 hours after randomization. Delayed coronary angiography group Delayed coronary angiography after stabilization of heart failure Delayed coronary angiography group will receive coronary angiography during hospitalization after stabilization of symptoms and signs of heart failure.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Rate of stroke Up to 12 months Rate of stroke during initial hospitalization
In-hospital mortality Up to 12 months All-cause 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
Rate of recurrent ischemia Up to 12 months Rate of recurrent ischemia 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
Cumulative incidence rate of cardiogenic shock Up to 12 months Cumulative incidence rate of cardiogenic shock
Cumulative incidence rate of major bleeding (BARC classification 3-5) Up to 12 months Cumulative incidence rate of major bleeding (BARC classification 3-5)
Cumulative incidence rate of non-fatal myocardial infarction Up to 12 months Cumulative incidence rate of non-fatal myocardial infarction
Peak level of troponin-I Up to 12 months Peak level of troponin-I during initial hospitalization
Cumulative incidence rate of rehospitalization due to heart failure Up to 12 months Cumulative incidence rate of rehospitalization due to heart failure
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
In-hospital cardiac mortality Up to 12 months Cardiac mortality 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
Duration of initial hospitalization Up to 12 months Duration of initial hospitalization (days)
Cumulative incidence rate of stroke Up to 12 months Cumulative incidence rate of stroke
Cumulative incidence rate of stent thrombosis Up to 12 months Cumulative incidence rate of stent thrombosis
Cumulative incidence rate of recurrent ischemia Up to 12 months Cumulative incidence rate of recurrent ischemia
Rate of Non-fatal myocardial infarction Up to 12 months Non-fatal myocardial infarction during initial hospitalization
Rate of major bleeding Up to 12 months Rate of major bleeding during initial hospitalization (BARC classificiation 3-5)
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 unplanned revascularization Up to 12 months Cumulative incidence rate of all unplanned revascularization
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
Cumulative incidence rate of all-cause death Up to 12 months Cumulative incidence rate of all-cause death
Cumulative incidence rate of cardiac death Up to 12 months Cumulative incidence rate of cardiac death
Trial Locations
- Locations (1)
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of