Use of Intra-aortic Balloon Pump Before Surgery for Acute Myocardial Infarction

Not Applicable

Completed

• Conditions: Coronary Bypass Graft Stenosis of Autologous Vessel; Acute Myocardial Infarction; Coronary Artery Disease; IABP - Disorder of Intra-Aortic Balloon Pump; Troponin
• Interventions: Other: Intra-aortic Balloon Pump

• Registration Number: NCT06468982
• Lead Sponsor: Ataturk University

Brief Summary

The optimal timing of surgery in patients with acute myocardial infarction (AMI) and the utilization of preoperative intra-aortic balloon pumps (IABP) in these patients are subjects of ongoing discussion and disagreement. This study aimed to investigate the effects of preoperative IABP on troponin levels, surgical timing, and intraoperative and postoperative outcomes for patients with AMI who undergo coronary artery bypass grafting (CABG).

Detailed Description

Percutaneous coronary intervention (PCI) is the first treatment for myocardial ischemia; however, if left main coronary artery disease, multivessel disease, or complex architecture disable PCI, 10% of patients may need coronary artery bypass grafting (CABG). Abstinence from surgical reperfusion in patients with acute myocardial infarction (AMI) may be justified due to surgery's 50% mortality rate. An intra-aortic balloon pump (IABP) can help patients who have ongoing ischemia and high cardiac enzymes because it changes the way the heart uses oxygen by increasing coronary blood flow and lowering afterload. Some guidelines do not recommend the use of IABP in patients with AMI except for mechanical complications or shock. Nevertheless, it is commonly acknowledged that the specific criteria for employing IABP differ among clinics and are determined by clinical expertise. Patients with AMI who have impaired coronary perfusion and require surgical revascularization can benefit from preoperative intra-aortic balloon pump (IABP) support. This intervention leads to reorganization of coronary perfusion, resulting in a decrease in elevated troponin levels and quicker myocardial recovery.

Study Timeline

• Study Start: 2021-05-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-17
• Study First Posted: 2024-06-21
• Results First Submitted: 2024-06-23
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Results First Posted: 2025-02-27
• Last Update Posted: 2025-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• Patients who have had acute myocardial infarction and have been decided on coronary surgical revascularization

Exclusion Criteria

• mechanical complications of Acute Myocardial Infarction (such as a ruptured chordal or ventricular septum)
• peripheral arterial disease
• renal failure
• history of cerebrovascular accident
• acute cardiogenic shock and cardiac arrest
• reoperation and combined operations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (IABP support)	Intra-aortic Balloon Pump	Patients who are receiving intra-aortic balloon pump support during the preoperative period

Primary Outcome Measures

Name	Time	Method
High-Sensitivity Cardiac Troponin Levels From Days 0-7	0-7 days	Daily repeated measurements of high-sensitivity cardiac troponin (hs-cTnI) on the ng/mL scale were compared between the two groups. The study hypothesizes that hs-cTnI levels decrease more rapidly in participants receiving IABP support compared to those without IABP. This decrease is posited to reflect a myocardial healing process.

Secondary Outcome Measures

Name	Time	Method
In-hospital Mortality	0-30 days	Deaths occurring in the first 30 days after the operation have been defined as mortality.

Trial Locations

Locations (1)

Atatürk University; 🇹🇷 Erzurum, Turkey