Acute Myocardial InfarctionNCT06468982
Use of Intra-aortic Balloon Pump Before Surgery for Acute Myocardial Infarction
A study testing Intra-aortic Balloon Pump in people with Acute Myocardial Infarction and Coronary Artery Disease, run by Ataturk University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Myocardial Infarction, Coronary Artery Disease, Coronary Bypass Graft Stenosis of Autologous Vessel
- What is being tested?
- Intra-aortic Balloon Pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 May 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have had acute myocardial infarction and have been decided on coronary surgical revascularization
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Atatürk University
Erzurum, 25100
Atatürk University
Yakutiye, Erzurum, 25100
About this study
Official title: Evidence of the Advantages of Preoperative Intra-aortic Balloon Pump in Surgical Revascularization of 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).
Read the 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.
- Conditions
- Acute Myocardial Infarction, Coronary Artery Disease, Coronary Bypass Graft Stenosis of Autologous Vessel, Troponin, IABP - Disorder of Intra-Aortic Balloon Pump
- Being tested
- Intra-aortic Balloon Pump
- Keywords
- Acute myocardial infarction, coronary artery bypass surgery, intra-aortic balloon pump, high-sensitivity cardiac troponin I
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-aortic Balloon PumpDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (IABP support) | Active comparator | Patients who are receiving intra-aortic balloon pump support during the preoperative period Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-7 days
Secondary outcomes (1)
In-hospital Mortality
Deaths occurring in the first 30 days after the operation have been defined as mortality.
Measured: 0-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 May 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ümit arslan, Ataturk University
- Investigators
- Ümit Arslan, assoc prof, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468982
- Sponsor's protocol ID
- AÜ-CVS-UA-01
- Status last verified
- Feb 2025
- First submitted
- 17 Jun 2024
- Last updated
- 27 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence of the Advantages of Preoperative Intra-aortic Balloon Pump in Surgical Revascularization of Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06468982
- Acronym / sponsor ID
- AÜ-CVS-UA-01
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Jun 2024 (actual)
- Results
- Posted 27 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Group A (IABP support) | Active comparator | Device: Intra-aortic Balloon PumpPatients who are receiving intra-aortic balloon pump support during the preoperative period |
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have had acute myocardial infarction and have been decided on coronary surgical revascularization
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-aortic Balloon PumpAlso: Datascope Corp. model:The CS300 with IntelliSense combines fiber-opticIt 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. | Device | Group A (IABP support) |
Primary outcome
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.
1 secondary outcome
In-hospital Mortality
Time frame: 0-30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ümit Arslan, assoc prof principal investigator
Ataturk University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-aortic Balloon Pump in people with Acute Myocardial Infarction and Coronary Artery Disease, run by Ataturk University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-Sensitivity Cardiac Troponin Levels From Days 0-7 (time frame: 0-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.