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

Evidence of the Advantages of Preoperative Intra-aortic Balloon Pump in Surgical Revascularization of Acute Myocardial Infarction

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).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Acute Myocardial Infarction; Troponin; Coronary Bypass Graft Stenosis of Autologous Vessel; IABP - Disorder of Intra-Aortic Balloon Pump
• Intervention / Treatment: Device: Intra-aortic Balloon Pump

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 Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Erzurum, Turkey, 25100
    • Ataturk University
  • Erzurum
    • Yakutiye, Erzurum, Turkey, 25100
      • Ataturk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (IABP support); Patients who are receiving intra-aortic balloon pump support during the preoperative period	Device: Intra-aortic Balloon Pump; It will be applied to patients with acute myocardial infarction who have elevated troponin levels and recurrent or persistent chest pain at rest, hemodynamic instability, multivascular disease, left main coronary artery disease, and patients with narrow and/or tortuous coronary artery anatomy in whom PCI has failed or is not applicable.; Other Names: Datascope Corp. model:The CS300 with IntelliSense combines fiber-optic
No Intervention: Group B (control group; without IABP support); Patients who did not receive intra-aortic balloon pump support in the preoperative period; control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High-Sensitivity Cardiac Troponin Levels From Days 0-7	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.	0-7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital Mortality	Deaths occurring in the first 30 days after the operation have been defined as mortality.	0-30 days

Collaborators and Investigators

• Sponsor: Ataturk University
• Investigators: Principal Investigator: Ümit Arslan, assoc prof, Ataturk University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: coronary artery bypass surgery; Acute myocardial infarction; intra-aortic balloon pump; high-sensitivity cardiac troponin I
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Ischemia; Coronary Artery Disease; Myocardial Infarction; Infarction
• Other Study ID Numbers: AÜ-CVS-UA-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No