Trial Outcomes & Findings for Use of Intra-aortic Balloon Pump Before Surgery for Acute Myocardial Infarction (NCT NCT06468982)
NCT ID: NCT06468982
Last Updated: 2025-02-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
156 participants
Primary outcome timeframe
0-7 days
Results posted on
2025-02-27
Participant Flow
Participants were selected based on their participation in a single center's cardiovascular surgery and cardiology council from May 2021 to December 2023. The first participant was enrolled on May 1, 2021 and the last participant was enrolled on December 31,2023.
Participant milestones
| Measure |
Group A (IABP Support)
Patients who are receiving intra-aortic balloon pump support during the preoperative period
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.
|
Group B (Control Group; Without IABP Support)
Patients who did not receive intra-aortic balloon pump support in the preoperative period; control group
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
92
|
|
Overall Study
COMPLETED
|
64
|
92
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Intra-aortic Balloon Pump Before Surgery for Acute Myocardial Infarction
Baseline characteristics by cohort
| Measure |
Group A (IABP Support)
n=64 Participants
Patients who are receiving intra-aortic balloon pump support during the preoperative period
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.
|
Group B (Control Group; Without IABP Support)
n=92 Participants
Patients who did not receive intra-aortic balloon pump support in the preoperative period; control group
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 8.9 • n=99 Participants
|
65.2 years
STANDARD_DEVIATION 8.1 • n=107 Participants
|
64.6 years
STANDARD_DEVIATION 8.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
156 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
High sensitive cardiac troponin-I levels
|
29.2 ng/mL
STANDARD_DEVIATION 20.5 • n=99 Participants
|
17.3 ng/mL
STANDARD_DEVIATION 16.6 • n=107 Participants
|
20.4 ng/mL
STANDARD_DEVIATION 18.3 • n=206 Participants
|
|
EuroScore II
|
2.2 Percentage of risk (%)
STANDARD_DEVIATION 1.4 • n=99 Participants
|
2 Percentage of risk (%)
STANDARD_DEVIATION 1.2 • n=107 Participants
|
2.1 Percentage of risk (%)
STANDARD_DEVIATION 1.2 • n=206 Participants
|
|
Chest pain score
|
7.6 scores on a scale
STANDARD_DEVIATION 1.8 • n=99 Participants
|
2.3 scores on a scale
STANDARD_DEVIATION 1.4 • n=107 Participants
|
5.1 scores on a scale
STANDARD_DEVIATION 3.2 • n=206 Participants
|
|
C-reactive protein levels
|
23.4 mg/L (0-5)
STANDARD_DEVIATION 19.8 • n=99 Participants
|
21.7 mg/L (0-5)
STANDARD_DEVIATION 16.4 • n=107 Participants
|
22.2 mg/L (0-5)
STANDARD_DEVIATION 17.3 • n=206 Participants
|
|
Percentage of glycated hemoglobin (HbA1c)
|
7.4 percentage of glycated hemoglobin
STANDARD_DEVIATION 2.3 • n=99 Participants
|
6.7 percentage of glycated hemoglobin
STANDARD_DEVIATION 1.9 • n=107 Participants
|
6.8 percentage of glycated hemoglobin
STANDARD_DEVIATION 2.1 • n=206 Participants
|
|
Left ventricular ejection fraction
|
44.9 percentage of ejected blood (50-65%)
STANDARD_DEVIATION 7.7 • n=99 Participants
|
47.9 percentage of ejected blood (50-65%)
STANDARD_DEVIATION 7.0 • n=107 Participants
|
47.1 percentage of ejected blood (50-65%)
STANDARD_DEVIATION 7.3 • n=206 Participants
|
PRIMARY outcome
Timeframe: 0-7 daysPopulation: Daily troponin results were recorded for both groups
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.
Outcome measures
| Measure |
Group A (IABP Support)
n=64 Participants
Patients who are receiving intra-aortic balloon pump support during the preoperative period
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.
|
Group B (Control Group; Without IABP Support)
n=92 Participants
Patients who did not receive intra-aortic balloon pump support in the preoperative period; control group
|
|---|---|---|
|
High-Sensitivity Cardiac Troponin Levels From Days 0-7
0.days
|
29.2 ng/mL (0-0.04)
Standard Deviation 20.5
|
17.3 ng/mL (0-0.04)
Standard Deviation 16.6
|
|
High-Sensitivity Cardiac Troponin Levels From Days 0-7
1.days
|
23.2 ng/mL (0-0.04)
Standard Deviation 17.7
|
16.7 ng/mL (0-0.04)
Standard Deviation 16.3
|
|
High-Sensitivity Cardiac Troponin Levels From Days 0-7
2.days
|
15.8 ng/mL (0-0.04)
Standard Deviation 13.2
|
14.9 ng/mL (0-0.04)
Standard Deviation 14.8
|
|
High-Sensitivity Cardiac Troponin Levels From Days 0-7
3.days
|
9.9 ng/mL (0-0.04)
Standard Deviation 9.3
|
12.3 ng/mL (0-0.04)
Standard Deviation 12.6
|
|
High-Sensitivity Cardiac Troponin Levels From Days 0-7
4.days
|
5.9 ng/mL (0-0.04)
Standard Deviation 6.2
|
9.5 ng/mL (0-0.04)
Standard Deviation 12.8
|
|
High-Sensitivity Cardiac Troponin Levels From Days 0-7
5.days
|
4.4 ng/mL (0-0.04)
Standard Deviation 4.5
|
6.9 ng/mL (0-0.04)
Standard Deviation 10
|
|
High-Sensitivity Cardiac Troponin Levels From Days 0-7
6.days
|
2.3 ng/mL (0-0.04)
Standard Deviation 2.2
|
5.3 ng/mL (0-0.04)
Standard Deviation 7.5
|
|
High-Sensitivity Cardiac Troponin Levels From Days 0-7
7.days
|
1.5 ng/mL (0-0.04)
Standard Deviation 1.7
|
4.2 ng/mL (0-0.04)
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: 0-30 daysPopulation: The analysis includes patients with acute myocardial infarction undergoing coronary artery bypass grafting (CABG) and follows mortality 0-30 days postoperatively, defined as in-hospital death.
Deaths occurring in the first 30 days after the operation have been defined as mortality.
Outcome measures
| Measure |
Group A (IABP Support)
n=64 Participants
Patients who are receiving intra-aortic balloon pump support during the preoperative period
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.
|
Group B (Control Group; Without IABP Support)
n=92 Participants
Patients who did not receive intra-aortic balloon pump support in the preoperative period; control group
|
|---|---|---|
|
In-hospital Mortality
|
4 Participants
|
7 Participants
|
Adverse Events
Group A (IABP Support)
Serious events: 12 serious events
Other events: 12 other events
Deaths: 4 deaths
Group B (Control Group; Without IABP Support)
Serious events: 13 serious events
Other events: 16 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Group A (IABP Support)
n=64 participants at risk
Patients who are receiving intra-aortic balloon pump support during the preoperative period
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.
|
Group B (Control Group; Without IABP Support)
n=92 participants at risk
Patients who did not receive intra-aortic balloon pump support in the preoperative period; control group
|
|---|---|---|
|
Cardiac disorders
low cardiac output syndrome
|
3.1%
2/64 • 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
Adverse effects, including neurological complications, atrial fibrillation, low output syndrome, and revision due to bleeding, were recorded among participants in both groups.
|
5.4%
5/92 • 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
Adverse effects, including neurological complications, atrial fibrillation, low output syndrome, and revision due to bleeding, were recorded among participants in both groups.
|
|
Nervous system disorders
Neurological complications
|
1.6%
1/64 • 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
Adverse effects, including neurological complications, atrial fibrillation, low output syndrome, and revision due to bleeding, were recorded among participants in both groups.
|
4.3%
4/92 • 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
Adverse effects, including neurological complications, atrial fibrillation, low output syndrome, and revision due to bleeding, were recorded among participants in both groups.
|
|
Blood and lymphatic system disorders
Surgical revision for bleeding
|
14.1%
9/64 • 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
Adverse effects, including neurological complications, atrial fibrillation, low output syndrome, and revision due to bleeding, were recorded among participants in both groups.
|
4.3%
4/92 • 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
Adverse effects, including neurological complications, atrial fibrillation, low output syndrome, and revision due to bleeding, were recorded among participants in both groups.
|
Other adverse events
| Measure |
Group A (IABP Support)
n=64 participants at risk
Patients who are receiving intra-aortic balloon pump support during the preoperative period
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.
|
Group B (Control Group; Without IABP Support)
n=92 participants at risk
Patients who did not receive intra-aortic balloon pump support in the preoperative period; control group
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
18.8%
12/64 • 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
Adverse effects, including neurological complications, atrial fibrillation, low output syndrome, and revision due to bleeding, were recorded among participants in both groups.
|
17.4%
16/92 • 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
Adverse effects, including neurological complications, atrial fibrillation, low output syndrome, and revision due to bleeding, were recorded among participants in both groups.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place