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Completed

NCT Number: NCT06468982

Use of Intra-aortic Balloon Pump Before Surgery for 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).

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk University, Yakutiye, Erzurum, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intra-Aortic Balloon Pump

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.

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

Primary outcomes

  1. High-Sensitivity Cardiac Troponin Levels From Days 0-7

    Time frame: 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 outcomes

  1. In-hospital Mortality

    Time frame: 0-30 days

    Deaths occurring in the first 30 days after the operation have been defined as mortality.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 21, 2024
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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