IABP for MI-VSD Patients in SCAI SHOCK Stage B

NCT07267884 | Not Yet Recruiting DMC

• 1 other identifier: KYLL-202506-052-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Myocardial Infarction (AMI); Ventricular Septal Defects (VSD)

Keywords

Intra-aortic balloon pump; acute myocardial infarction; ventricular septal defect; cardiogenic shock

Outcome Measures

Primary Outcomes (1)

• All-cause mortality within 30 days after MI-VSD

  From enrollment to the 30th day of MI-VSD

Secondary Outcomes (4)

• Number of participants who progress to SCAI SHOCK stages C-E

  30 days after MI-VSD

• Number of participants who undergo surgical repair for ventricular septal defect

  30 days after MI-VSD

• 6-month all-cause mortality after MI-VSD

  From enrollment to 6 months after MI-VSD

• 1-year all-cause mortality after MI-VSD

  From enrollment to 1 year after MI-VSD

Study Arms (2)

Early-CS-IABP group

EXPERIMENTAL

Immediate placement (within 8 hours) of an IABP followed by medication upon admission

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.

Interventions

Insertion of IABP in SCAI SHOCK stage B DEVICE

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.

Early-CS-IABP group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• The Second Hospital of Shandong University: collaborator
• Jinan Central Hospital: collaborator
• Qilu Hospital of Shandong University: lead
• Shandong Provincial Hospital: collaborator
• Qianfoshan Hospital: collaborator

Study Sites (1)

Department of Cardiology, Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (9)

• 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.

  PMID: 40939873 RESULT

• Ibanez 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.

  PMID: 28886621 RESULT

• Rao 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.

  PMID: 40014670 RESULT

• Thiele 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.

  PMID: 22920912 RESULT

• Naidu 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.

  PMID: 35115207 RESULT

• Poulsen 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.

  PMID: 18442545 RESULT

• Khan 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.

  PMID: 29643872 RESULT

• Figueras 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.

  PMID: 19064683 RESULT

• Matteucci 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.

  PMID: 33157063 RESULT

MeSH Terms

Conditions

Heart Septal Defects, Ventricular; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Myocardial Infarction; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Jianmin Yang

  Qilu Hospital of Shandong University, Department of Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linsong Leng

CONTACT

+86 18663195283; lenglinsong1907@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, Randomized, Open-Label, Parallel Controlled Study

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: December 5, 2025
• Study Start: February 28, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): October 31, 2029
• Last Updated: March 19, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Beginning 4 months and ending 2 years after the publication of results
• Access Criteria: Access to the de-identified IPD will be granted to qualified researchers who provide a sound and methodologically valid research proposal.

Locations

CN (1)