IABP for MI-VSD Patients in SCAI SHOCK Stage B

Ventricular septal defect (MI-VSD) is a serious mechanical complication of acute myocardial infarction, with an extremely high mortality. Intra-aortic balloon pump (IABP) is still the most easily available mechanical assistive device for clinical management, and it has become a bridge to surgical repair. IABP-SHOCK II trial is currently the largest randomized controlled trial (RCT) related to the use of IABP among patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS), the trial found that IABP had a negative impact on 30-day, 1-year, and 6-year all-cause mortality. However, the trial included patients with typical cardiogenic shock (shock stages C-E, SCAI definition criteria), most of whom had severely inadequate microcirculatory perfusion, limiting the effectiveness of IABP treatment. There is still no clinical study on the usage of IABP in MI-VSD patients with early-stage CS. The main objective of this study is to assess the correlation between the utilization of IABP and 30-day mortality rates among MI-VSD patients with early-stage CS. The investigators will also follow up on the long-term prognosis of these patients. The investigators will enroll multicenter patients with MI-VSD who are at the onset of cardiogenic shock (SCAI SHOCK stage B) to explore the impact of IABP support on the prognosis of these patients. This prospective, multicenter, randomized, open-label, parallel-group controlled study will involve 100 participants who are diagnosed with MI-VSD complicated by SCAI SHOCK stage B in about 5 centers. After reviewing the inclusion criteria, participants will be randomized to two groups (Early-CS-IABP group and Control group) in a ratio of 1:1. The primary outcome is all-cause mortality within 30 days after MI-VSD. The investigators will also observe 6-month and 1-year all-cause mortality after MI-VSD. The investigators speculated that IABP could significantly improve the clinical outcomes of patients with MI-VSD if it could be used in the early stage of cardiogenic shock.

NCT Number	NCT07267884
Lead Sponsor	Qilu Hospital of Shandong University Collaborators: Shandong Provincial Hospital, Qianfoshan Hospital, The Second Hospital of Shandong University, Jinan Central Hospital
Conditions	Acute Myocardial Infarction (AMI), Ventricular Septal Defects (VSD)
Enrollment	100 participants
Start Date	2026-02-28
Primary Completion	2028-02-28 (estimated)
Study Completion	2029-10-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-19