IABP In AMI Patients With SCAI-B Study

NCT04989777 NA UNKNOWN

Acute myocardial infarction (AMI) is the most common cause of cardiogenic shock (CS), and CS is the most common cause of death in patients with AMI. Percutaneous mechanical circulation is one of the most important techniques in the treatment of AMICS. Intra-aortic balloon pump (IABP) is the most commonly used mechanical circulatory assist device in clinic. However, the existing clinical evidence shows that IABP can not improve the clinical outcome of patients with AMICS. As for impella and extracorporeal membrane oxygenation (ECMO) system, there was still no difference in overall mortality compared with IABP in AMICS. Until now, IABP-shock II study is the largest randomized controlled study so far. However, this study has limitations. In a recent retrospective study, the project team investigated the use of IABP and the outcomes of more than 300 AMI cases in three provincial capitals of Northeast China in 2016. It was found that the 28 day survival rate of patients in the early use of IABP group was significantly higher than that in the late use group. The investigators speculate that IABP may significantly improve the clinical outcomes of patients with AMICS if it can be used in the earlier stage of CS (stage B). This multicenter, prospective, randomized controlled study will involve 512 participants in about 15 centers. Patients diagnosed with AMI (including STEMI and NSTEMI) complicated with shock stage B (SCAI definition criteria) received early revascularization (PCI or CABG) and standardized drug treatment according to the current guidelines before meeting the study inclusion criteria. After reviewing the inclusion criteria, participants were randomized to two groups (IABP group and control group) in a ratio of 1:1. The investigators speculated that IABP could significantly improve the clinical outcomes of patients with AMICS if it could be used in the earlier stage of CS (stage B). At present, there is no clinical study on the use of IABP in AMICS (stage B). It is worth carrying out the corresponding clinical research, in order to study the real role of IABP in patients with AMICS and explore the treatment strategy of AMICS in line with China's national conditions.

Details

Lead sponsor	Renmin Hospital of Wuhan University
Phase	NA
Status	UNKNOWN
Enrolment	512
Start date	Sat Jan 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu Jan 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Myocardial Infarction, Acute
• Cardiogenic Shock

Interventions

• IABP (Intra-aortic balloon pump ) implantation

Countries

China