Immediate coronary angiography
ProcedureImmediate coronary angiography ≤2 hours after randomization
NCT Number: NCT07002164
Study objectives:
To determine the optimal timing of coronary angiography (CAG) in patients with non-ST-segment elevation myocardial infarction (NSTEMI) complicated by acute decompensated heart failure (AHF). The primary objective of this trial is to test the hypothesis that immediate CAG ≤2 hours after establishment of NSTEMI diagnosis would result in a significant reduction in primary composite outcome of death from any cause, non-fatal myocardial infarction (MI), or hospitalization for heart failure (HF) at 12 months after randomization as compared with delayed CAG after stabilization.
Study hypothesis:
Immediate CAG ≤2 hours after establishment of NSTEMI diagnosis would result in a significant reduction in primary composite outcome of death from any cause, non-fatal myocardial infarction (MI), or hospitalization for heart failure (HF) at 12 months after randomization as compared with delayed CAG after stabilization.
Background:
Although current guidelines recommend early CAG within 2 hours for patients with NSTEMI complicated by AHF, many patients with NSTEMI complicated by AHF did not receive early CAG. However, no randomized clinical trials have evaluated the optimal timing of CAG in patients with NSTEMI complicated by AHF. Therefore, the investigators aimed to perform a prospective, investigator-initiated, open-label, muilticenter trial to compare the efficacy and safety between immediate CAG (CAG <2 hours after establishment of NSTEMI diagnosis) and delayed CAG after stabilization (i.e. improved dyspnea and disappearance of pulmonary congestion) in participants with NSTEMI complicated by AHF.
Study procedure:
Following the establishment of NSTEMI diagnosis, participants fulfilling the eligibility criteria will be randomized at a ratio of 1:1 to immediate CAG ≤2 hours after randomization or delayed CAG after stabilization on another day during hospitalization.
Interested in participating?
Request Info19 year and older
All sexes
Interventional
Not applicable
Gyeongsang National University Changwon Hospital, Changwon, South Korea
Acute decompensated heart failure (AHF) is frequently encountered in patients with non-ST-segment elevation myocardial infarction (NSTEMI), and it is known to be associated with worse clinical outcomes that those without heart failure (HF). Although current guidelines recommend immediate invasive strategy for patients with NSTEMI complicated by AHF, its evidence is lack. It is difficult to decide whether to perform early coronary angiography (CAG) according to the guidelines in these high-risk patients due to the risk of procedural complications. Furthermore, the most of randomized trials regarding the timing of CAG in non-ST-segment elevation acute coronary syndrome (NSTE-ACS) have excluded these patients, therefore, there is lack of evidence for performing immediate CAG in such cases. In clinical practice, many patients with NSTEMI complicated by AHF did not receive early CAG. There are only two observational studies which investigated this issue. In the Korean nationwide registry data, a total of 1,027 patients with NSTEMI complicated by AHF were analyzed, and 14.5% among study population underwent early CAG within 2 hours according to the guidelines. All-cause mortality at 12 months was not significantly different irrespective of CAG timing. In other single-center study, early CAG <24 hours was associated with a lower risk of adverse cardiac outcomes compared with delayed CAG ≥24 hours after admission.
Several studies have demonstrated improved clinical outcomes in high-risk patients with NSTE-ACS undergoing early CAG, whereas others have found no significant differences in clinical outcomes. Randomized clinical trials, such as SISCA, ISAR-COOL, RIDDLE-NSTEMI and EARLY, have demonstrated the advantages of early CAG compared to delayed invasive approach (i.e. CAG after stabilization) in high-risk patients with NSTE-ACS. The other trials regarding this issue have failed to show the superiority of early CAG over delayed invasive approach. However, no randomized clinical trials have evaluated the optimal timing of CAG in patients with NSTEMI complicated by AHF.
Therefore, the investigators aimed to perform a prospective, investigator-initiated, open-label, muilticenter trial to compare the efficacy and safety between immediate CAG (CAG <2 hours after establishment of NSTEMI diagnosis) and delayed CAG after stabilization (i.e. improved dyspnea and disappearance of pulmonary congestion) in participants with NSTEMI complicated by AHF.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Immediate coronary angiography ≤2 hours after randomization
Delayed coronary angiography after stabilization
Time frame: 1 year
Time frame: 1, 6, 24, 36 months
Time frame: 1, 6, 12, 24, 36 months
Time frame: 1, 6, 12, 24, 36 months
Time frame: 1, 6, 12, 24, 36 months
Time frame: 1, 6, 12, 24, 36 months
Time frame: 1, 6, 12, 24, 36 months
Recurrent ischemia is defined as repeated episodes of ischemic symptoms needing emergent coronary angiography with any of the following signs:
Time frame: 1, 6, 12, 24, 36 months
Time frame: 1, 6, 12, 24, 36 months
Time frame: 1, 6, 12, 24, 36 months
Time frame: 1, 6, 12, 24, 36 months
Time frame: Up to 7 days
Time frame: Up to 30 days
Time frame: Up to 30 days
Contact information is provided by the study sponsor or research team.
Min Chul Kim, Professor
CONTACT
82-62-220-6578 ext. 82-62-220-6578
Youngkeun Ahn, Professor
CONTACT
82-62-220-4764 ext. 82-62-220-4764
Chonnam National University Hospital
Other
Trial of IMmediate Invasive Versus Delayed Coronary ANGiography in Non-ST-Segment Elevation Myocardial Infarction Complicated by Acute Decompensated Heart Failure: The TIMING-AHF Trial
Acronym: TIMING-AHF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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