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

NCT ID: NCT06468982

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2023-12-31

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.

Conditions

Acute Myocardial Infarction; Coronary Artery Disease; Coronary Bypass Graft Stenosis of Autologous Vessel; Troponin; IABP - Disorder of Intra-Aortic Balloon Pump

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A (IABP support)

Patients who are receiving intra-aortic balloon pump support during the preoperative period

Group Type: ACTIVE_COMPARATOR

Intra-aortic Balloon Pump

Intervention Type: DEVICE

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.

Group B (control group; without IABP support)

Patients who did not receive intra-aortic balloon pump support in the preoperative period; control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Datascope Corp. model:The CS300 with IntelliSense combines fiber-optic

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

ümit arslan

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ümit Arslan, assoc prof

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

Locations

Atatürk University

Yakutiye, Erzurum, Turkey (Türkiye)

Atatürk University

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

AÜ-CVS-UA-01

Identifier Type: -

Identifier Source: org_study_id