IABP In AMI Patients With SCAI-B Study

NCT04989777 | Unknown DMC

• 1 other identifier: 68752
• Study Type: interventional
• Target: 512
• Locations: 1 country
• Sites: 1

Brief Summary

Acute myocardial infarction (AMI) is the most common cause of cardiogenic shock (CS), and CS is the most common cause of death in patients with AMI. Percutaneous mechanical circulation is one of the most important techniques in the treatment of AMICS. Intra-aortic balloon pump (IABP) is the most commonly used mechanical circulatory assist device in clinic. However, the existing clinical evidence shows that IABP can not improve the clinical outcome of patients with AMICS. As for impella and extracorporeal membrane oxygenation (ECMO) system, there was still no difference in overall mortality compared with IABP in AMICS. Until now, IABP-shock II study is the largest randomized controlled study so far. However, this study has limitations. In a recent retrospective study, the project team investigated the use of IABP and the outcomes of more than 300 AMI cases in three provincial capitals of Northeast China in 2016. It was found that the 28 day survival rate of patients in the early use of IABP group was significantly higher than that in the late use group. The investigators speculate that IABP may significantly improve the clinical outcomes of patients with AMICS if it can be used in the earlier stage of CS (stage B). This multicenter, prospective, randomized controlled study will involve 512 participants in about 15 centers. Patients diagnosed with AMI (including STEMI and NSTEMI) complicated with shock stage B (SCAI definition criteria) received early revascularization (PCI or CABG) and standardized drug treatment according to the current guidelines before meeting the study inclusion criteria. After reviewing the inclusion criteria, participants were randomized to two groups (IABP group and control group) in a ratio of 1:1. The investigators speculated that IABP could significantly improve the clinical outcomes of patients with AMICS if it could be used in the earlier stage of CS (stage B). At present, there is no clinical study on the use of IABP in AMICS (stage B). It is worth carrying out the corresponding clinical research, in order to study the real role of IABP in patients with AMICS and explore the treatment strategy of AMICS in line with China's national conditions.

Conditions

Myocardial Infarction, Acute; Cardiogenic Shock

Keywords

IABP; Acute myocardial infarction; cardiogenic shock; SCAI-B

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular Event

  All-cause death

  In-hospital 30-day

Study Arms (2)

Control group

NO INTERVENTION

Patients with AMI and shock stage B were received Standardized treatment

IABP group

EXPERIMENTAL

Patients with AMI and shock stage B were received Standardized treatment and IABP treatment

Device: IABP (Intra-aortic balloon pump ) implantation

Interventions

IABP (Intra-aortic balloon pump ) implantation DEVICE

Eligible AMI patients in SCAI-B stage will receive IABP implantation from the femoral artery

IABP group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-85 years with AMI (STEMI or NSTEMI) and shock stage B (SCAI definition criteria)
• Plan to implement revascularization (PCI or CABG)
• Hypotension: SBP \< 90mmHg or map \< 60mmhg or decrease \> 30mmhg from baseline, more than 30min under the condition of sufficient blood volume; (4) No signs of hypoperfusion (if one of the following conditions is met):1) Good mental state; 2) The extremities were warm without cold and wet; 3) Lactic acid ≤ 2 mm; 4) Normal renal function or mild renal impairment (creatinine increase less than one time or GFR decrease ≤ 50%.

You may not qualify if:

• Age \> 85
• CPR \> 30 min
• Stage C-E in SCAI shock definition criteria
• Acute pulmonary embolism
• Mechanical complications, such as ventricular septal perforation, acute mitral regurgitation
• Non-drug induced severe central nervous system dysfunction
• Other causes of shock, such as septic shock, hemorrhagic shock, ketoacidosis
• Aortic insufficiency above grade II
• Difficulty in IABP implantation due to severe peripheral vascular disease
• Combined with other serious diseases and life expectancy \< 12 months
• Refusal to sign the informed consent

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Sites (1)

Renmin hospital of Wuhan university

Wuhan, Hubei, 430000, China

Location

Related Publications (10)

• Goldberg RJ, Spencer FA, Gore JM, Lessard D, Yarzebski J. Thirty-year trends (1975 to 2005) in the magnitude of, management of, and hospital death rates associated with cardiogenic shock in patients with acute myocardial infarction: a population-based perspective. Circulation. 2009 Mar 10;119(9):1211-9. doi: 10.1161/CIRCULATIONAHA.108.814947. Epub 2009 Feb 23.

  PMID: 19237658 RESULT

• Barron HV, Every NR, Parsons LS, Angeja B, Goldberg RJ, Gore JM, Chou TM; Investigators in the National Registry of Myocardial Infarction 2. The use of intra-aortic balloon counterpulsation in patients with cardiogenic shock complicating acute myocardial infarction: data from the National Registry of Myocardial Infarction 2. Am Heart J. 2001 Jun;141(6):933-9. doi: 10.1067/mhj.2001.115295.

  PMID: 11376306 RESULT

• Antman EM, Anbe DT, Armstrong PW, Bates ER, Green LA, Hand M, Hochman JS, Krumholz HM, Kushner FG, Lamas GA, Mullany CJ, Ornato JP, Pearle DL, Sloan MA, Smith SC Jr, Alpert JS, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Gregoratos G, Halperin JL, Hiratzka LF, Hunt SA, Jacobs AK; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1999 Guidelines for the Management of Patients With Acute Myocardial Infarction). ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1999 Guidelines for the Management of Patients With Acute Myocardial Infarction). Circulation. 2004 Aug 3;110(5):588-636. doi: 10.1161/01.CIR.0000134791.68010.FA. No abstract available.

  PMID: 15289388 RESULT

• Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, Filippatos G, Fox K, Huber K, Kastrati A, Rosengren A, Steg PG, Tubaro M, Verheugt F, Weidinger F, Weis M; ESC Committee for Practice Guidelines (CPG). Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008 Dec;29(23):2909-45. doi: 10.1093/eurheartj/ehn416. Epub 2008 Nov 12. No abstract available.

  PMID: 19004841 RESULT

• Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, de Waha A, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Lauer B, Bohm M, Ebelt H, Schneider S, Werdan K, Schuler G; Intraaortic Balloon Pump in cardiogenic shock II (IABP-SHOCK II) trial investigators. Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial. Lancet. 2013 Nov 16;382(9905):1638-45. doi: 10.1016/S0140-6736(13)61783-3. Epub 2013 Sep 3.

  PMID: 24011548 RESULT

• Thiele H, Zeymer U, Thelemann N, Neumann FJ, Hausleiter J, Abdel-Wahab M, Meyer-Saraei R, Fuernau G, Eitel I, Hambrecht R, Bohm M, Werdan K, Felix SB, Hennersdorf M, Schneider S, Ouarrak T, Desch S, de Waha-Thiele S; IABP-SHOCK II Trial (Intraaortic Balloon Pump in Cardiogenic Shock II) Investigators; IABP-SHOCK II Investigators. Intraaortic Balloon Pump in Cardiogenic Shock Complicating Acute Myocardial Infarction: Long-Term 6-Year Outcome of the Randomized IABP-SHOCK II Trial. Circulation. 2019 Jan 15;139(3):395-403. doi: 10.1161/CIRCULATIONAHA.118.038201. Epub 2018 Nov 11.

  PMID: 30586721 RESULT

• Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Ting HH, O'Gara PT, Kushner FG, Ascheim DD, Brindis RG, Casey DE Jr, Chung MK, de Lemos JA, Diercks DB, Fang JC, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2015 ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention and the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction. J Am Coll Cardiol. 2016 Mar 15;67(10):1235-1250. doi: 10.1016/j.jacc.2015.10.005. Epub 2015 Oct 21. No abstract available.

  PMID: 26498666 RESULT

• Henry TD, Tomey MI, Tamis-Holland JE, Thiele H, Rao SV, Menon V, Klein DG, Naka Y, Pina IL, Kapur NK, Dangas GD; American Heart Association Interventional Cardiovascular Care Committee of the Council on Clinical Cardiology; Council on Arteriosclerosis, Thrombosis and Vascular Biology; and Council on Cardiovascular and Stroke Nursing. Invasive Management of Acute Myocardial Infarction Complicated by Cardiogenic Shock: A Scientific Statement From the American Heart Association. Circulation. 2021 Apr 13;143(15):e815-e829. doi: 10.1161/CIR.0000000000000959. Epub 2021 Mar 4.

  PMID: 33657830 RESULT

• Baran DA, Grines CL, Bailey S, Burkhoff D, Hall SA, Henry TD, Hollenberg SM, Kapur NK, O'Neill W, Ornato JP, Stelling K, Thiele H, van Diepen S, Naidu SS. SCAI clinical expert consensus statement on the classification of cardiogenic shock: This document was endorsed by the American College of Cardiology (ACC), the American Heart Association (AHA), the Society of Critical Care Medicine (SCCM), and the Society of Thoracic Surgeons (STS) in April 2019. Catheter Cardiovasc Interv. 2019 Jul 1;94(1):29-37. doi: 10.1002/ccd.28329. Epub 2019 May 19.

  PMID: 31104355 RESULT

• Subspecialty Group of Acute and Intensive Cardiac Care of Chinese Society of Cardiology; Editorial Board of Chinese Journal of Cardiology. [Chinese experts consensus on the diagnosis and treatment of cardiogenic shock(2018)]. Zhonghua Xin Xue Guan Bing Za Zhi. 2019 Apr 24;47(4):265-277. doi: 10.3760/cma.j.issn.0253-3758.2019.04.003. Chinese.

  PMID: 31060185 RESULT

MeSH Terms

Conditions

Myocardial Infarction; Shock, Cardiogenic

Interventions

Intra-Aortic Balloon Pumping

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Counterpulsation; Assisted Circulation; Surgical Procedures, Operative

Study Officials

• Liwei Cheng

  Renmin Hospital of Wuhan University

  STUDY DIRECTOR

Central Study Contacts

Jing Chen, PhD

CONTACT

13659840327; chenjing1984@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 4, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: August 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)