Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04810806
Status:
TERMINATED
Last Update Posted:
2024-03-01
First Post:
2021-03-14
Brief Title:
Timing of Coronary Angiography in NSTE-ACS With ADHF
Sponsor:
Chonnam National University Hospital
Organization:
Chonnam National University Hospital
Study Overview
Official Title:
Immediate Versus Delayed Coronary Angiography in Patients With Non-ST-Segment Acute Coronary Syndrome With Acute Decompensated Heart Failure
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EARLY-HF
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 11 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None