Acute Myocardial Infarction (AMI)IABP-VISTASNCT07267884
IABP for MI-VSD Patients in SCAI SHOCK Stage B
A study testing Insertion of IABP in SCAI SHOCK stage B in people with Acute Myocardial Infarction (AMI) and Ventricular Septal Defects (VSD), run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Ventricular septal defect (MI-VSD) is a serious mechanical complication of acute myocardial infarction, with an extremely high mortality. Intra-aortic balloon pump (IABP) is still the most easily available mechanical assistive device for clinical management, and it has become a bridge to surgical repair. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction (AMI), Ventricular Septal Defects (VSD)
- What is being tested?
- Insertion of IABP in SCAI SHOCK stage B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2026to 31 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years;
- Diagnosed with AMI based on clinical manifestations, electrocardiogram, cardiac troponin markers, etc.;
- Diagnosis of MI-VSD by echocardiography;
- Patients in stage B according to the SCAI shock stage definition before enrollment, meeting the following conditions: (1) good mental status, (2) warm limbs without cold and clammy feeling, (3) Killip class 2, with the beginning of wet rales at the lung bases, (4) arterial blood lactate ≤ 2mmol/L, (5) normal renal function or mild renal impairment (creatinine increase less than 1.5 times baseline or eGFR decrease ≤ 50%), (6) no use of vasoactive drugs;
- Obtain informed consent.
Who cannot join
- Age > 75 years;
- Congenital heart disease with ventricular septal defect;
- Complications such as free wall rupture, papillary muscle dysfunction, etc.;
- Typical cardiogenic shock (SCAI shock stages C-E) before enrollment, any of the following: (1) altered mental status, (2) cold and clammy skin, (3) Killip class 3 or 4, (4) arterial blood lactate > 2mmol/L, (5) severe liver and kidney function impairment, (6) use of vasoactive drugs to maintain blood pressure; or in shock risk period (stage A);
- Chronic end-stage organ dysfunction that is not expected to be suitable for surgical treatment;
- Shock caused by other reasons (such as sepsis or hypovolemia);
Show all 11Show fewer
- Patients with an expected life span of less than 12 months;
- Aortic valve insufficiency more than grade II, aortic dissection or aneurysm cannot be ruled out;
- Difficulty in implanting IABP due to severe peripheral vascular disease or other reasons;
- Pregnancy and lactation;
- Refusal to sign the informed consent form, disagreement to insert IABP, or no willingness to proceed with further surgical treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Cardiology, Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Xiangjuan Liu, （+86）0531-82165053, xiangjuanliu@163.com
About this study
Official title: Evaluation of the Effectiveness and Safety of Intra-Aortic Balloon Pump Insertion in Patients With Ventricular Septal Defect Following Myocardial Infarction During SCAI SHOCK Stage B: A Multicenter, Randomized, Open-Label, Parallel Controlled Study
Ventricular septal defect (MI-VSD) is a serious mechanical complication of acute myocardial infarction, with an extremely high mortality. Intra-aortic balloon pump (IABP) is still the most easily available mechanical assistive device for clinical management, and it has become a bridge to surgical repair.
IABP-SHOCK II trial is currently the largest randomized controlled trial (RCT) related to the use of IABP among patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS), the trial found that IABP had a negative impact on 30-day, 1-year, and 6-year all-cause mortality. However, the trial included patients with typical cardiogenic shock (shock stages C-E, SCAI definition criteria), most of whom had severely inadequate microcirculatory perfusion, limiting the effectiveness of IABP treatment.
Read more
There is still no clinical study on the usage of IABP in MI-VSD patients with early-stage CS. The main objective of this study is to assess the correlation between the utilization of IABP and 30-day mortality rates among MI-VSD patients with early-stage CS. The investigators will also follow up on the long-term prognosis of these patients. The investigators will enroll multicenter patients with MI-VSD who are at the onset of cardiogenic shock (SCAI SHOCK stage B) to explore the impact of IABP support on the prognosis of these patients.
This prospective, multicenter, randomized, open-label, parallel-group controlled study will involve 100 participants who are diagnosed with MI-VSD complicated by SCAI SHOCK stage B in about 5 centers. After reviewing the inclusion criteria, participants will be randomized to two groups (Early-CS-IABP group and Control group) in a ratio of 1:1. The primary outcome is all-cause mortality within 30 days after MI-VSD. The investigators will also observe 6-month and 1-year all-cause mortality after MI-VSD.
The investigators speculated that IABP could significantly improve the clinical outcomes of patients with MI-VSD if it could be used in the early stage of cardiogenic shock.
Read the detailed description
- Background Ventricular septal defect (MI-VSD) is a severe mechanical complication of acute myocardial infarction with an extremely high mortality rate. Previous studies have shown that MI-VSD occurs in 1% to 3% of patients with ST-segment elevation myocardial infarction (STEMI), and in patients with acute myocardial infarction complicated by cardiogenic shock (AMICS), the incidence of MI-VSD increases to 3.9% . The early and long-term prognosis for MI-VSD remains poor. A study found that the 30-day, 1-year, and 5-year mortality rates for patients with MI-VSD were 62%, 72%, and 95%, respectively, with the 30-day mortality rate for patients treated medically being 100%. Traditional shock stage criteria cannot accurately identify the pre-shock stage, thus failing to implement timely intervention measures to prevent hemodynamic deterioration. In 2022, the Society for Cardiovascular Angiography and Interventions (SCAI) proposed a shock stage classification system that divides shock into stage A to E, defined as at risk, beginning, classic, deteriorating, and extremis, providing a risk stratification for mortality in CS patients. According to this staging system, patients begin to exhibit significant hemodynamic disturbances and inadequate microcirculatory perfusion at SCAI SHOCK stage C, which is the typical cardiogenic shock stage. IABP-SHOCK II trial is currently the largest randomized controlled trial (RCT) related to the use of IABP among patients with AMICS. The trial found that IABP had a negative impact on all-cause mortality within 30 days, 1 year, and 6 years for AMICS patients. Therefore, the 2025 ACC/AHA/ACEP/NAEMSP/SCAI guidelines for the treatment of acute coronary syndrome (ACS) recommend against routine use of IABP as a standard supportive therapy in patients with AMICS. However, the trial included patients with typical cardiogenic shock (SCAI SHOCK stages C-E), most of whom had severely inadequate microcirculatory perfusion, limiting the effectiveness of IABP treatment. Patients with MI-VSD experienced rapid hemodynamic changes, and untreated ventricular septal perforation areas might further expand. Despite the current guideline downgrading the recommendation for routine use of IABP in patients with AMICS, it remains the most prevalent method utilized in clinical practice. According to the investigators' retrospective study based on MI-VSD patients who were admitted to Qilu Hospital of Shandong University from 2013 to 2024, the use of IABP could remarkably reduce the 30-day mortality and improve long-term prognosis in patients with early-stage cardiogenic shock (SCAI SHOCK stages A/B) at baseline, but did not improve outcomes in those with typical cardiogenic shock (SCAI SHOCK stages C-E). Significant differences between clinical practice and guidelines suggest that a specific population of MI-VSD patients may respond well to IABP support. This study aims to enroll multicenter patients with MI-VSD who are at the onset of cardiogenic shock (SCAI SHOCK stage B) to explore the impact of IABP support on the prognosis of these patients. This study include patients in shock stage B because they are at the beginning of AMICS and also a critical period for treatment.
- Speculated conclusion The investigators speculated that IABP could significantly improve the clinical outcomes of patients with MI-VSD if it could be used in the early stage of cardiogenic shock.
- Study Design 3.1 Design Prospective, multicenter, randomized, open-label, parallel-group controlled trial 3.2 Study Participant Grouping The grouping will be conducted using a central randomized complete random design. After reviewing the inclusion criteria, participants will be randomized to two groups in a ratio of 1:1. (1) Early-CS-IABP group: Immediate placement (within 8 hours) of an IABP followed by medication upon admission; (2) Control group: Routine medication treatment upon admission. According to the current guidelines, patients will receive IABP insertion to maintain circulation when they progress to SCAI SHOCK stages C-E. For patients with SCAI SHOCK stages C-E who have had IABP inserted, crossover to the early IABP group is not allowed, as they do not receive early intervention in stage B 3.3 Sample Size Based on the data from previous studies, assuming a 30-day all-cause mortality rate of 50% in the control group and an Early-CS-IABP group can reduce the mortality rate to 20%, with α=0.05 (two-sided) and β=0.1 (90% power), we calculate that at least 47 patients are needed in each group, totaling 94 patients. Considering 5% possible attrition and data loss, we aim to recruit a total of 100 participants.
3.4 Sample collection Whole blood specimen 10mL 4 Statistical Methods Statistical analysis will be conducted using SPSS and R. The population will be randomly divided into the IABP group and the control group. Baseline data and clinical outcomes of the study population will be compared for differences. Continuous variables will be analyzed for differences using T-tests, ANOVA, and nonparametric tests. Categorical variables will be analyzed using the chi-square test for statistical analysis. Kaplan-Meier survival curves will be used to estimate the 30-day cumulative mortality rates in the IABP group and the control group, and the Log-rank test will be used to compare the differences between the two groups. Subgroup analyses will be conducted to compare the association between early IABP implantation and 30-day all-cause mortality in different subgroups, and to analyze interactions. Secondary endpoints and safety endpoints will be evaluated using Fisher's exact test or the chi-square test for binary endpoint assessment, or the Mann-Whitney U test for quantitative endpoint assessment. The investigators will conduct Cox regression analysis to evaluate the impact of IABP implantation on 6-month and 1-year mortality. A p-value less than 0.05 is considered statistically significant.
- Being tested
- Insertion of IABP in SCAI SHOCK stage B
- Keywords
- Intra-aortic balloon pump, acute myocardial infarction, ventricular septal defect, cardiogenic shock
- Medical subject headings
- Heart Septal Defects, Ventricular, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of IABP in SCAI SHOCK stage BDevice
For patients in Early-CS-IABP group, IABP will be inserted within 8 hours after admission, along with medical treatment to maintain circulatory stability. Once the Department of Cardiovascular Surgery determines that a patient has surgical indications, he will be transferred to the surgery department for surgical septal repair.
| Study group | Role | What they receive |
|---|---|---|
| Early-CS-IABP group | Experimental | Immediate placement (within 8 hours) of an IABP followed by medication upon admission Receives: Device: Insertion of IABP in SCAI SHOCK stage B |
| Control group | No intervention | Routine medication treatment upon admission. According to the current guidelines, patients will receive IABP insertion to maintain circulation when they progress to SCAI SHOCK stages C-E. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality within 30 days after MI-VSD
Measured: From enrollment to the 30th day of MI-VSD
Secondary outcomes (4)
Number of participants who progress to SCAI SHOCK stages C-E
Participants meeting the following criteria will be considered to progress to SCAI SHOCK stages C-E: (1) altered mental status, (2) cold and clammy skin, (3) Killip class 3 or 4, (4) arterial blood gas lactate > 2 mmol/L, (5) severe liver and kidney function impairment, (6) use of vasoactive drugs to maintain blood pressure. In the case report form, participants with shock progression were recorded as "1" while those without progression were recorded as "0".
Measured: 30 days after MI-VSD
Number of participants who undergo surgical repair for ventricular septal defect
Determine whether the participants have undergone surgical repair of ventricular septal defect based on the hospital's electronic medical record system. In the case report form, participants who have undergone surgical repair for ventricular septal defect were recorded as "1" while those without surgical repair were recorded as "0".
Measured: 30 days after MI-VSD
6-month all-cause mortality after MI-VSD
Measured: From enrollment to 6 months after MI-VSD
1-year all-cause mortality after MI-VSD
Measured: From enrollment to 1 year after MI-VSD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start28 Feb 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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
- Multicenter, Randomized, Open-Label, Parallel Controlled Study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital, Qianfoshan Hospital, The Second Hospital of Shandong University, Jinan Central Hospital
- Responsible party
- Sponsor
- Investigators
- Jianmin Yang, Principal investigator, Qilu Hospital of Shandong University, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267884
- Sponsor's protocol ID
- KYLL-202506-052-1
- Acronym
- IABP-VISTAS
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic statistics Vital signs Current medical history Past medical history and accompanying diseases Examinations and laboratory tests results IABP usage information Other treatments Medication use Follow-up information
Publications
Leng L, Liu X, Song C, Ran X, Lin Z, Zhai C, Qin X, Cao G, Zhang C, Yang J. Intra-aortic balloon pump implantation in early-stage cardiogenic shock reduces 30-day mortality in patients with ventricular septal defect following myocardial infarction. Int J Cardiol. 2026 Jan 1;442:133895. doi: 10.1016/j.ijcard.2025.133895. Epub 2025 Sep 10.
PubMed 40939873Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
PubMed 28886621Rao SV, O'Donoghue ML, Ruel M, Rab T, Tamis-Holland JE, Alexander JH, Baber U, Baker H, Cohen MG, Cruz-Ruiz M, Davis LL, de Lemos JA, DeWald TA, Elgendy IY, Feldman DN, Goyal A, Isiadinso I, Menon V, Morrow DA, Mukherjee D, Platz E, Promes SB, Sandner S, Sandoval Y, Schunder R, Shah B, Stopyra JP, Talbot AW, Taub PR, Williams MS. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025 Apr;151(13):e771-e862. doi: 10.1161/CIR.0000000000001309. Epub 2025 Feb 27.
PubMed 40014670Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Fuhrmann J, Bohm M, Ebelt H, Schneider S, Schuler G, Werdan K; IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1287-96. doi: 10.1056/NEJMoa1208410. Epub 2012 Aug 26.
PubMed 22920912Naidu SS, Baran DA, Jentzer JC, Hollenberg SM, van Diepen S, Basir MB, Grines CL, Diercks DB, Hall S, Kapur NK, Kent W, Rao SV, Samsky MD, Thiele H, Truesdell AG, Henry TD. SCAI SHOCK Stage Classification Expert Consensus Update: A Review and Incorporation of Validation Studies: This statement was endorsed by the American College of Cardiology (ACC), American College of Emergency Physicians (ACEP), American Heart Association (AHA), European Society of Cardiology (ESC) Association for Acute Cardiovascular Care (ACVC), International Society for Heart and Lung Transplantation (ISHLT), Society of Critical Care Medicine (SCCM), and Society of Thoracic Surgeons (STS) in December 2021. J Am Coll Cardiol. 2022 Mar 8;79(9):933-946. doi: 10.1016/j.jacc.2022.01.018. Epub 2022 Jan 31. No abstract available.
PubMed 35115207Poulsen SH, Praestholm M, Munk K, Wierup P, Egeblad H, Nielsen-Kudsk JE. Ventricular septal rupture complicating acute myocardial infarction: clinical characteristics and contemporary outcome. Ann Thorac Surg. 2008 May;85(5):1591-6. doi: 10.1016/j.athoracsur.2008.01.010.
PubMed 18442545Khan MY, Waqar T, Qaisrani PG, Khan AZ, Khan MS, Zaman H, Jalal A. Surgical Repair of post-infarction ventricular septal rupture: Determinants of operative mortality and survival outcome analysis. Pak J Med Sci. 2018 Jan-Feb;34(1):20-26. doi: 10.12669/pjms.341.13906.
PubMed 29643872Figueras J, Alcalde O, Barrabes JA, Serra V, Alguersuari J, Cortadellas J, Lidon RM. Changes in hospital mortality rates in 425 patients with acute ST-elevation myocardial infarction and cardiac rupture over a 30-year period. Circulation. 2008 Dec 16;118(25):2783-9. doi: 10.1161/CIRCULATIONAHA.108.776690. Epub 2008 Dec 8.
PubMed 19064683Matteucci M, Ronco D, Corazzari C, Fina D, Jiritano F, Meani P, Kowalewski M, Beghi C, Lorusso R. Surgical Repair of Postinfarction Ventricular Septal Rupture: Systematic Review and Meta-Analysis. Ann Thorac Surg. 2021 Jul;112(1):326-337. doi: 10.1016/j.athoracsur.2020.08.050. Epub 2020 Nov 4.
PubMed 33157063
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness and Safety of Intra-Aortic Balloon Pump Insertion in Patients With Ventricular Septal Defect Following Myocardial Infarction During SCAI SHOCK Stage B: A Multicenter, Randomized, Open-Label, Parallel Controlled Study
- ClinicalTrials.gov ID
- NCT07267884
- Acronym / sponsor ID
- IABP-VISTAS / KYLL-202506-052-1
- Keywords
- Intra-aortic balloon pump, acute myocardial infarction, ventricular septal defect, cardiogenic shock
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital, Qianfoshan Hospital, The Second Hospital of Shandong University, Jinan Central Hospital
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ventricular septal defect (MI-VSD) is a serious mechanical complication of acute myocardial infarction, with an extremely high mortality. Intra-aortic balloon pump (IABP) is still the most easily available mechanical assistive device for clinical management, and it has become a bridge to surgical repair.
IABP-SHOCK II trial is currently the largest randomized controlled trial (RCT) related to the use of IABP among patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS), the trial found that IABP had a negative impact on 30-day, 1-year, and 6-year all-cause mortality. However, the trial included patients with typical cardiogenic shock (shock stages C-E, SCAI definition criteria), most of whom had severely inadequate microcirculatory perfusion, limiting the effectiveness of IABP treatment.
There is still no clinical study on the usage of IABP in MI-VSD patients with early-stage CS. The main objective of this study is to assess the correlation between the utilization of IABP and 30-day mortality rates among MI-VSD patients with early-stage CS. The investigators will also follow up on the long-term prognosis of these patients. The investigators will enroll multicenter patients with MI-VSD who are at the onset of cardiogenic shock (SCAI SHOCK stage B) to explore the impact of IABP support on the prognosis of these patients.
This prospective, multicenter, randomized, open-label, parallel-group controlled study will involve 100 participants who are diagnosed with MI-VSD complicated by SCAI SHOCK stage B in about 5 centers. After reviewing the inclusion criteria, participants will be randomized to two groups (Early-CS-IABP group and Control group) in a ratio of 1:1. The primary outcome is all-cause mortality within 30 days after MI-VSD. The investigators will also observe 6-month and 1-year all-cause mortality after MI-VSD.
The investigators speculated that IABP could significantly improve the clinical outcomes of patients with MI-VSD if it could be used in the early stage of cardiogenic shock.
Detailed description
- Background Ventricular septal defect (MI-VSD) is a severe mechanical complication of acute myocardial infarction with an extremely high mortality rate. Previous studies have shown that MI-VSD occurs in 1% to 3% of patients with ST-segment elevation myocardial infarction (STEMI), and in patients with acute myocardial infarction complicated by cardiogenic shock (AMICS), the incidence of MI-VSD increases to 3.9% . The early and long-term prognosis for MI-VSD remains poor. A study found that the 30-day, 1-year, and 5-year mortality rates for patients with MI-VSD were 62%, 72%, and 95%, respectively, with the 30-day mortality rate for patients treated medically being 100%. Traditional shock stage criteria cannot accurately identify the pre-shock stage, thus failing to implement timely intervention measures to prevent hemodynamic deterioration. In 2022, the Society for Cardiovascular Angiography and Interventions (SCAI) proposed a shock stage classification system that divides shock into stage A to E, defined as at risk, beginning, classic, deteriorating, and extremis, providing a risk stratification for mortality in CS patients. According to this staging system, patients begin to exhibit significant hemodynamic disturbances and inadequate microcirculatory perfusion at SCAI SHOCK stage C, which is the typical cardiogenic shock stage. IABP-SHOCK II trial is currently the largest randomized controlled trial (RCT) related to the use of IABP among patients with AMICS. The trial found that IABP had a negative impact on all-cause mortality within 30 days, 1 year, and 6 years for AMICS patients. Therefore, the 2025 ACC/AHA/ACEP/NAEMSP/SCAI guidelines for the treatment of acute coronary syndrome (ACS) recommend against routine use of IABP as a standard supportive therapy in patients with AMICS. However, the trial included patients with typical cardiogenic shock (SCAI SHOCK stages C-E), most of whom had severely inadequate microcirculatory perfusion, limiting the effectiveness of IABP treatment. Patients with MI-VSD experienced rapid hemodynamic changes, and untreated ventricular septal perforation areas might further expand. Despite the current guideline downgrading the recommendation for routine use of IABP in patients with AMICS, it remains the most prevalent method utilized in clinical practice. According to the investigators' retrospective study based on MI-VSD patients who were admitted to Qilu Hospital of Shandong University from 2013 to 2024, the use of IABP could remarkably reduce the 30-day mortality and improve long-term prognosis in patients with early-stage cardiogenic shock (SCAI SHOCK stages A/B) at baseline, but did not improve outcomes in those with typical cardiogenic shock (SCAI SHOCK stages C-E). Significant differences between clinical practice and guidelines suggest that a specific population of MI-VSD patients may respond well to IABP support. This study aims to enroll multicenter patients with MI-VSD who are at the onset of cardiogenic shock (SCAI SHOCK stage B) to explore the impact of IABP support on the prognosis of these patients. This study include patients in shock stage B because they are at the beginning of AMICS and also a critical period for treatment.
- Speculated conclusion The investigators speculated that IABP could significantly improve the clinical outcomes of patients with MI-VSD if it could be used in the early stage of cardiogenic shock.
- Study Design 3.1 Design Prospective, multicenter, randomized, open-label, parallel-group controlled trial 3.2 Study Participant Grouping The grouping will be conducted using a central randomized complete random design. After reviewing the inclusion criteria, participants will be randomized to two groups in a ratio of 1:1. (1) Early-CS-IABP group: Immediate placement (within 8 hours) of an IABP followed by medication upon admission; (2) Control group: Routine medication treatment upon admission. According to the current guidelines, patients will receive IABP insertion to maintain circulation when they progress to SCAI SHOCK stages C-E. For patients with SCAI SHOCK stages C-E who have had IABP inserted, crossover to the early IABP group is not allowed, as they do not receive early intervention in stage B 3.3 Sample Size Based on the data from previous studies, assuming a 30-day all-cause mortality rate of 50% in the control group and an Early-CS-IABP group can reduce the mortality rate to 20%, with α=0.05 (two-sided) and β=0.1 (90% power), we calculate that at least 47 patients are needed in each group, totaling 94 patients. Considering 5% possible attrition and data loss, we aim to recruit a total of 100 participants.
3.4 Sample collection Whole blood specimen 10mL 4 Statistical Methods Statistical analysis will be conducted using SPSS and R. The population will be randomly divided into the IABP group and the control group. Baseline data and clinical outcomes of the study population will be compared for differences. Continuous variables will be analyzed for differences using T-tests, ANOVA, and nonparametric tests. Categorical variables will be analyzed using the chi-square test for statistical analysis. Kaplan-Meier survival curves will be used to estimate the 30-day cumulative mortality rates in the IABP group and the control group, and the Log-rank test will be used to compare the differences between the two groups. Subgroup analyses will be conducted to compare the association between early IABP implantation and 30-day all-cause mortality in different subgroups, and to analyze interactions. Secondary endpoints and safety endpoints will be evaluated using Fisher's exact test or the chi-square test for binary endpoint assessment, or the Mann-Whitney U test for quantitative endpoint assessment. The investigators will conduct Cox regression analysis to evaluate the impact of IABP implantation on 6-month and 1-year mortality. A p-value less than 0.05 is considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, Randomized, Open-Label, Parallel Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Early-CS-IABP group | Experimental | Device: Insertion of IABP in SCAI SHOCK stage BImmediate placement (within 8 hours) of an IABP followed by medication upon admission |
| Control group | No intervention | –Routine medication treatment upon admission. According to the current guidelines, patients will receive IABP insertion to maintain circulation when they progress to SCAI SHOCK stages C-E. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 75 years;
- Diagnosed with AMI based on clinical manifestations, electrocardiogram, cardiac troponin markers, etc.;
- Diagnosis of MI-VSD by echocardiography;
- Patients in stage B according to the SCAI shock stage definition before enrollment, meeting the following conditions: (1) good mental status, (2) warm limbs without cold and clammy feeling, (3) Killip class 2, with the beginning of wet rales at the lung bases, (4) arterial blood lactate ≤ 2mmol/L, (5) normal renal function or mild renal impairment (creatinine increase less than 1.5 times baseline or eGFR decrease ≤ 50%), (6) no use of vasoactive drugs;
- Obtain informed consent.
Key exclusion criteria (11 listed)
- Age > 75 years;
- Congenital heart disease with ventricular septal defect;
- Complications such as free wall rupture, papillary muscle dysfunction, etc.;
- Typical cardiogenic shock (SCAI shock stages C-E) before enrollment, any of the following: (1) altered mental status, (2) cold and clammy skin, (3) Killip class 3 or 4, (4) arterial blood lactate > 2mmol/L, (5) severe liver and kidney function impairment, (6) use of vasoactive drugs to maintain blood pressure; or in shock risk period (stage A);
- Chronic end-stage organ dysfunction that is not expected to be suitable for surgical treatment;
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 |
|---|---|---|
| Insertion of IABP in SCAI SHOCK stage BFor patients in Early-CS-IABP group, IABP will be inserted within 8 hours after admission, along with medical treatment to maintain circulatory stability. Once the Department of Cardiovascular Surgery determines that a patient has surgical indications, he will be transferred to the surgery department for surgical septal repair. | Device | Early-CS-IABP group |
Primary outcome
All-cause mortality within 30 days after MI-VSD
Time frame: From enrollment to the 30th day of MI-VSD
4 secondary outcomes
Number of participants who progress to SCAI SHOCK stages C-E
Time frame: 30 days after MI-VSD
Number of participants who undergo surgical repair for ventricular septal defect
Time frame: 30 days after MI-VSD
6-month all-cause mortality after MI-VSD
Time frame: From enrollment to 6 months after MI-VSD
1-year all-cause mortality after MI-VSD
Time frame: From enrollment to 1 year after MI-VSD
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Results publication: PubMed 40939873Leng L, Liu X, Song C, Ran X, Lin Z, Zhai C, Qin X, Cao G, Zhang C, Yang J. Intra-aortic balloon pump implantation in early-stage cardiogenic shock reduces 30-day mortality in patients with ventricular septal defect following myocardial infarction. Int J Cardiol. 2026 Jan 1;442:133895. doi: 10.1016/j.ijcard.2025.133895. Epub 2025 Sep 10.
- Results publication: PubMed 28886621Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
- Results publication: PubMed 40014670Rao SV, O'Donoghue ML, Ruel M, Rab T, Tamis-Holland JE, Alexander JH, Baber U, Baker H, Cohen MG, Cruz-Ruiz M, Davis LL, de Lemos JA, DeWald TA, Elgendy IY, Feldman DN, Goyal A, Isiadinso I, Menon V, Morrow DA, Mukherjee D, Platz E, Promes SB, Sandner S, Sandoval Y, Schunder R, Shah B, Stopyra JP, Talbot AW, Taub PR, Williams MS. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025 Apr;151(13):e771-e862. doi: 10.1161/CIR.0000000000001309. Epub 2025 Feb 27.
- Results publication: PubMed 22920912Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Fuhrmann J, Bohm M, Ebelt H, Schneider S, Schuler G, Werdan K; IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1287-96. doi: 10.1056/NEJMoa1208410. Epub 2012 Aug 26.
- Results publication: PubMed 35115207Naidu SS, Baran DA, Jentzer JC, Hollenberg SM, van Diepen S, Basir MB, Grines CL, Diercks DB, Hall S, Kapur NK, Kent W, Rao SV, Samsky MD, Thiele H, Truesdell AG, Henry TD. SCAI SHOCK Stage Classification Expert Consensus Update: A Review and Incorporation of Validation Studies: This statement was endorsed by the American College of Cardiology (ACC), American College of Emergency Physicians (ACEP), American Heart Association (AHA), European Society of Cardiology (ESC) Association for Acute Cardiovascular Care (ACVC), International Society for Heart and Lung Transplantation (ISHLT), Society of Critical Care Medicine (SCCM), and Society of Thoracic Surgeons (STS) in December 2021. J Am Coll Cardiol. 2022 Mar 8;79(9):933-946. doi: 10.1016/j.jacc.2022.01.018. Epub 2022 Jan 31. No abstract available.
- Results publication: PubMed 18442545Poulsen SH, Praestholm M, Munk K, Wierup P, Egeblad H, Nielsen-Kudsk JE. Ventricular septal rupture complicating acute myocardial infarction: clinical characteristics and contemporary outcome. Ann Thorac Surg. 2008 May;85(5):1591-6. doi: 10.1016/j.athoracsur.2008.01.010.
- Results publication: PubMed 29643872Khan MY, Waqar T, Qaisrani PG, Khan AZ, Khan MS, Zaman H, Jalal A. Surgical Repair of post-infarction ventricular septal rupture: Determinants of operative mortality and survival outcome analysis. Pak J Med Sci. 2018 Jan-Feb;34(1):20-26. doi: 10.12669/pjms.341.13906.
- Results publication: PubMed 19064683Figueras J, Alcalde O, Barrabes JA, Serra V, Alguersuari J, Cortadellas J, Lidon RM. Changes in hospital mortality rates in 425 patients with acute ST-elevation myocardial infarction and cardiac rupture over a 30-year period. Circulation. 2008 Dec 16;118(25):2783-9. doi: 10.1161/CIRCULATIONAHA.108.776690. Epub 2008 Dec 8.
- Results publication: PubMed 33157063Matteucci M, Ronco D, Corazzari C, Fina D, Jiritano F, Meani P, Kowalewski M, Beghi C, Lorusso R. Surgical Repair of Postinfarction Ventricular Septal Rupture: Systematic Review and Meta-Analysis. Ann Thorac Surg. 2021 Jul;112(1):326-337. doi: 10.1016/j.athoracsur.2020.08.050. Epub 2020 Nov 4.
- Individual participant dataSharing planned: Yes. Demographic statistics Vital signs Current medical history Past medical history and accompanying diseases Examinations and laboratory tests results IABP usage information Other treatments Medication use Follow-up information
Related trials for Acute Myocardial Infarction (AMI)
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
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.
Jianmin Yang principal investigator
Qilu Hospital of Shandong University, Department of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insertion of IABP in SCAI SHOCK stage B in people with Acute Myocardial Infarction (AMI) and Ventricular Septal Defects (VSD), run by Qilu Hospital of Shandong University at 1 site in China.
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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linsong Leng (+86 18663195283, lenglinsong1907@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality within 30 days after MI-VSD (time frame: From enrollment to the 30th day of MI-VSD). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07267884, which also lists 9 linked publications.
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 19 Mar 2026.