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

NCT06468982 — Not applicable, Completed, 156 participants, Ataturk University

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

RegistryNCT06468982
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment156 (Actual)
SponsorAtaturk University (Other)
ConditionsAcute Myocardial Infarction, Coronary Artery Disease, Coronary Bypass Graft Stenosis of Autologous Vessel, Troponin, IABP - Disorder of Intra-Aortic Balloon Pump
InterventionsIntra-aortic Balloon Pump (Device)
Datesstart 2021-05-01, primary completion 2023-12-31, completion 2023-12-31, first posted 2024-06-21, last updated 2025-02-27
Locations2 sites in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Acute Myocardial Infarction All trials for Coronary Artery Disease All trials of Intra-aortic Balloon Pump

-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).

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Group A (IABP support)Active comparatorDevice: Intra-aortic Balloon PumpPatients who are receiving intra-aortic balloon pump support during the preoperative period
Group B (control group; without IABP support)No interventionPatients who did not receive intra-aortic balloon pump support in the preoperative period; control group
  • Intra-aortic Balloon Pump (Device), also known as Datascope Corp. model:The CS300 with IntelliSense combines fiber-optic: 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.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • In-hospital Mortality [0-30 days]: Deaths occurring in the first 30 days after the operation have been defined as mortality.

+Eligibility

Sex: All, ages: 18 Years to 85 Years

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

+Posted results

Participant flow

MilestoneGroup A (IABP Support)Group B (Control Group; Without IABP Support)
Started6492
Completed6492
Not completed00

Outcome results

  • High-Sensitivity Cardiac Troponin Levels From Days 0-7 (Primary), Mean, ng/mL (0-0.04): Group A (IABP Support) 29.2 +/- 20.5; Group B (Control Group; Without IABP Support) 17.3 +/- 16.6 (p 0.05)
  • In-hospital Mortality (Secondary), Count of participants, Participants: Group A (IABP Support) 4; Group B (Control Group; Without IABP Support) 7 (p <0.05)

Adverse events

Time frame: Adverse events were recorded during the period from the 1st to the 30th postoperative day for each patient who underwent coronary artery bypass grafting surgery

ArmDeathsSerious adverse eventsOther adverse events
Group A (IABP Support)4/64 (6.3%)12/64 (18.8%)12/64 (18.8%)
Group B (Control Group; Without IABP Support)7/92 (7.6%)13/92 (14.1%)16/92 (17.4%)

Serious adverse events by term

TermOrgan systemGroup A (IABP Support)Group B (Control Group; Without IABP Support)
low cardiac output syndromeCardiac disorders2/645/92
Neurological complicationsNervous system disorders1/644/92
Surgical revision for bleedingBlood and lymphatic system disorders9/644/92

Other adverse events by term

TermOrgan systemGroup A (IABP Support)Group B (Control Group; Without IABP Support)
Atrial fibrillationCardiac disorders12/6416/92

Limitations and caveats: Not using more than one troponin test kit. The Swan-Ganz catheter or cardiac index device cannot be used in every patient.

+Locations (2)

FacilityCityCountryStatus
Atatürk UniversityYakutiye, ErzurumTurkey (Türkiye)
Atatürk UniversityErzurumTurkey (Türkiye)

+Study documents

+Investigators

  • Ümit Arslan, assoc prof, Principal investigator, Ataturk University