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

NCT06468982 | Completed Results

• 1 other identifier: AÜ-CVS-UA-01
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

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).

Conditions

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

Keywords

Acute myocardial infarction; coronary artery bypass surgery; intra-aortic balloon pump; high-sensitivity cardiac troponin I

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• In-hospital Mortality

  0-30 days

Study Arms (2)

Group A (IABP support)

ACTIVE COMPARATOR

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

Device: Intra-aortic Balloon Pump

Group B (control group; without IABP support)

NO INTERVENTION

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

Interventions

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.

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

Group A (IABP support)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (2)

Atatürk University

Yakutiye, Erzurum, 25100, Turkey (Türkiye)

Location

Atatürk University

Erzurum, 25100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Intra-Aortic Balloon Pumping

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Counterpulsation; Assisted Circulation; Surgical Procedures, Operative

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.

Results Point of Contact

• Title: Dr. Ümit Arslan
• Organization: Atatürk University

kvcumit@gmail.com

05418209007

Study Officials

• Ümit Arslan, assoc prof

  Ataturk University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: two groups for patients with acute myocardial infarction scheduled for coronary artery bypass Grafting: Group A with IABP support, and Group B (the control group) without IABP

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 21, 2024
• Study Start: May 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 27, 2025
• Results First Posted: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)