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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (IABP support) | Active Comparator | Patients who are receiving intra-aortic balloon pump support during the preoperative period |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital Mortality | Deaths occurring in the first 30 days after the operation have been defined as mortality. | 0-30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ümit Arslan, assoc prof | Ataturk University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atatürk University | Yakutiye | Erzurum | 25100 | Turkey (Türkiye) | ||
| Atatürk University |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2021 |
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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
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| Erzurum |
| 25100 |
| Turkey (Türkiye) |
| FG001 | Group B (Control Group; Without IABP Support) | Patients who did not receive intra-aortic balloon pump support in the preoperative period; control group |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Group B (Control Group; Without IABP Support) | Patients who did not receive intra-aortic balloon pump support in the preoperative period; control group |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Group A had an age range of 39 to 82 years, while Group B had an age range of 35 to 84 years. | Mean | Standard Deviation | years |
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| Sex: Female, Male | The study included patients who underwent coronary artery bypass graft surgery, regardless of gender. | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| High sensitive cardiac troponin-I levels | High-sensitivity cardiac troponin(hs-cTI) is used to diagnose for heart attacks. hs-cTI levels were quantified using a standardized electrochemiluminescence immunoassay. The limit of detection and the 99th percentile upper reference limit were determined based on the guidelines. Reference values were accepted as 0-0.04 ng/mL for both genders. The hs-cTI levels reported correspond to the values measured on the day of patient admission to our clinic. In Group A, the levels ranged from 5.4 to 83.6 ng/mL and in Group B,ranged from 1.1 to 92.5 ng/mL. | Mean | Standard Deviation | ng/mL |
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| EuroScore II | EuroSCORE II is a validated risk model with 18 parameters estimating mortality in cardiac surgery (www.euroscore.org). It represents the percentage likelihood of mortality, predicting how many similar patients may die. The scale ranges from 0% to %100. Higher values indicate worse prognosis and higher mortality risk. In this study, EuroSCORE II ranged from 0.5% to 7.4% in Group A and 0.6% to 6.8% in Group B | Mean | Standard Deviation | Percentage of risk (%) |
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| Chest pain score | he Wong-Baker FACES Pain Rating Scale assesses pain intensity using facial features on a 0-10 scale (0 = No hurt, 10 = Hurts worst). Individuals select the image that best represents their pain level (www.wongbakerfaces.org). In this study, pain scores ranged from 4 to 10 in Group A and from 0 to 8 in Group B. | Mean | Standard Deviation | scores on a scale |
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| C-reactive protein levels | C-reactive protein (CRP) is an acute-phase reactant produced by the liver in response to inflammation. CRP levels elevate during myocardial infarction (MI) primarily due to the inflammatory response triggered by myocardial injury. The normal range for CRP levels is generally considered to be less than 5 mg/L. The CRP levels in participants ranged from 3.2 to 115 mg/L for Group A and from 1.8 to 96 mg/L for Group B. | Mean | Standard Deviation | mg/L (0-5) |
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| Percentage of glycated hemoglobin (HbA1c) | HbA1c, also known as glycated hemoglobin, is an important biomarker for assessing glucose control, with elevated levels associated with an increased risk of diabetes-related complications; these levels are expressed as a percentage.(normal range 4.0% to 5.6%) It was measured at 4.0-13.4% in Group A patients and 4.3-12.5% in Group B patients. | Mean | Standard Deviation | percentage of glycated hemoglobin |
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| Left ventricular ejection fraction | Ejection fraction (EF) is a measurement that indicates the percentage of blood that is pumped out of the heart's left ventricle during each contraction, relative to the total volume of blood in the ventricle. It serves as a critical indicator of cardiac function, and is commonly used in the assessment of heart conditions, such as heart failure, with normal values typically ranging from 55% to 65%. The ejection fraction (EF) range in both groups of participants was 30% to 60%. | Mean | Standard Deviation | percentage of ejected blood (50-65%) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Daily troponin results were recorded for both groups | Posted | Mean | Standard Deviation | ng/mL (0-0.04) | 0-7 days |
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| Secondary | In-hospital Mortality | Deaths occurring in the first 30 days after the operation have been defined as mortality. | 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. | Posted | Count of Participants | Participants | 0-30 days |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 4 | 64 | 12 | 64 | 12 | 64 |
| EG001 | Group B (Control Group; Without IABP Support) | Patients who did not receive intra-aortic balloon pump support in the preoperative period; control group | 7 | 92 | 13 | 92 | 16 | 92 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| low cardiac output syndrome | Cardiac disorders | Systematic Assessment |
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| Neurological complications | Nervous system disorders | Systematic Assessment | cerebrovascular accident; stroke |
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| Surgical revision for bleeding | Blood and lymphatic system disorders | Systematic Assessment | Re-operation due to drainage due to postoperative mediastinal bleeding |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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Not using more than one troponin test kit. The Swan-Ganz catheter or cardiac index device cannot be used in every patient.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ümit Arslan | Atatürk University | 05418209007 | kvcumit@gmail.com |
| Dec 5, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 1, 2021 | Oct 16, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D007423 | Intra-Aortic Balloon Pumping |
| ID | Term |
|---|---|
| D015908 | Counterpulsation |
| D001243 | Assisted Circulation |
| D013514 | Surgical Procedures, Operative |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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To evaluate whether intra-aortic balloon pump catheter support contributes to a more rapid decrease in troponin levels and faster myocardial recovery, daily troponin levels were analyzed using mixed ANOVA. |
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