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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06468982
• Other study ID #: AÜ-CVS-UA-01
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2024
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• mechanical complications of AMI (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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Coronary Artery Disease
• Infarction
• Myocardial Infarction
• Troponin

Intervention

Other:
• Intra-aortic Balloon Pump
in patients with acute myocardial infarction involving elevated troponin levels and recurrent or persistent chest pain at rest, hemodynamic instability, multivessel disease, left main coronary artery disease, and narrow and/or tortuous coronary artery anatomy in which PCI has failed or is not feasible.

Locations

Country	Name	City	State
Turkey	Atatürk University	Erzurum
Turkey	Atatürk University	Yakutiye	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of decrease of high sensitive cardiac troponin	Daily comparison of repeated hsCTI measurements in both groups	10 days
Secondary	in-hospital mortality	Deaths occurring in the first 30 days after the operation will be defined as mortality.	30 days