IABP In AMI Patients With SCAI-B Study

Launched by RENMIN HOSPITAL OF WUHAN UNIVERSITY · Aug 3, 2021

Keywords

ClinConnect Summary

The IABP In AMI Patients With SCAI-B Study is a clinical trial aimed at understanding how an intra-aortic balloon pump (IABP) can help patients experiencing a severe heart condition called acute myocardial infarction (AMI) with cardiogenic shock stage B. This condition occurs when the heart is unable to pump enough blood, leading to low blood pressure and potentially serious complications. The trial will involve around 512 participants across 15 centers and will focus on patients aged 18 to 85 who meet specific health criteria, such as needing immediate heart procedures like angioplasty (PCI) or bypass surgery (CABG) and having low blood pressure but not showing signs of severe blood flow issues.

Eligible participants will be randomly assigned to either receive the IABP treatment or standard care to see if using the IABP earlier can improve their chances of survival and recovery. The study is important because it aims to provide new insights into the potential benefits of IABP in a specific stage of cardiogenic shock, which hasn't been thoroughly researched before. Participants can expect to follow the study guidelines closely and will be monitored throughout the trial. It's a chance to contribute to understanding better treatment options for this serious condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients aged 18-85 years with AMI (STEMI or NSTEMI) and shock stage B (SCAI definition criteria)
• • 2. Plan to implement revascularization (PCI or CABG)
• • 3. Hypotension: SBP \< 90mmHg or map \< 60mmhg or decrease \> 30mmhg from baseline, more than 30min under the condition of sufficient blood volume; (4) No signs of hypoperfusion (if one of the following conditions is met):1) Good mental state; 2) The extremities were warm without cold and wet; 3) Lactic acid ≤ 2 mm; 4) Normal renal function or mild renal impairment (creatinine increase less than one time or GFR decrease ≤ 50%.
• Exclusion Criteria:
• • 1. Age \> 85
• • 2. CPR \> 30 min
• • 3. Stage C-E in SCAI shock definition criteria
• • 4. Acute pulmonary embolism
• • 5. Mechanical complications, such as ventricular septal perforation, acute mitral regurgitation
• • 6. Non-drug induced severe central nervous system dysfunction
• • 7. Other causes of shock, such as septic shock, hemorrhagic shock, ketoacidosis
• • 8. Aortic insufficiency above grade II
• • 9. Difficulty in IABP implantation due to severe peripheral vascular disease
• • 10. Combined with other serious diseases and life expectancy \< 12 months
• • 11. Refusal to sign the informed consent