NCT00491036

Brief Summary

Patients in cardiogenic shock complicating acute myocardial infarction (AMI) are referred to a tertiary care center for percutaneous coronary intervention (PCI) of the infarct related artery in this multicenter, ran-domized clinical trial. After checking in- and exclusion criteria computerized randomization is performed to either PCI plus intraaortic balloon pump (IABP) insertion and medical treatment or PCI plus medical treatment only. Intensive care treatment is performed according to standard care including hemodynamic monitoring using a pulmonary artery catheter for optimal volume status adaptation and inotropic drug administration. The IABP will be weaned after hemodynamic stabilization. Primary outcome measure will be 30-day mortality. The secondary outcome measures such as hemody-namic, laboratory and clinical parameters will serve as surrogate for prognosis of the patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_4

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 25, 2007

Completed
1.9 years until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

May 2, 2017

Status Verified

May 1, 2017

Enrollment Period

3 years

First QC Date

June 22, 2007

Last Update Submit

May 1, 2017

Conditions

Myocardial InfarctionShock, Cardiogenic

Keywords

Acute myocardial infarctioncardiogenic shockpercutaneous coronary interventionintraaortic balloon counterpulsationAcute myocardial infarction - cardiogenic shock

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality

    30 day

Secondary Outcomes (13)

  • Inflammatory markers (CRP and white blood cell count)

    4 days

  • Hemodynamic Parameters (Blood pressure, Heart rate)

    3 days

  • Time till hemodynamic stabilization

    30 days

  • Catecholamine dose and duration of catecholamines

    30 days

  • Mean and area under the curve of serum lactate

    48 hours

  • +8 more secondary outcomes

Study Arms (2)

Intraaortic balloon pump

ACTIVE COMPARATOR

Patients in cardiogenic shock get an intraaortic balloon pump in the cath lab

Device: Intraaortic balloon pump

No intraaortic balloon pump

NO INTERVENTION

Patients in cardiogenic shock in this group get no intraaortic balloon pump

Interventions

Intraaortic balloon pumpDEVICE

intraaortic balloon pump from Datascope/Maquet or Arrow/Teleflex will be used

Intraaortic balloon pump

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cardiogenic shock complicating acute myocardial (STEMI or NSTEMI) with
  • intended revascularization (PCI or CABG)
  • Systolic blood pressure \< 90 mmHg \> 30 min or inotropes required to maintain pressure \> 90 mmHg during systole
  • Signs of pulmonary congestion
  • Signs of impaired organ perfusion with at least one of the following:
  • Altered mental status
  • Cold, clammy skin
  • Urine output \<30 ml/h
  • Serum lactate \>2mmol/l
  • Informed consent

You may not qualify if:

  • Resuscitation \> 30 minutes
  • Cerebral deficit with fixed dilated pupils
  • No intrinsic heart action
  • Mechanical infarction complication
  • Onset of shock \> 12 h
  • Severe peripheral artery disease
  • Aortic regurgitation \> II.°
  • Age \> 90 years
  • shock of other cause
  • Other severe concomitant disease
  • participation in another trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Zentralklinik Bad Berka GmbH

Bad Berka, 99437, Germany

Location

Herzzentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Segeberger Kliniken Gmbh

Bad Segeberg, 23795, Germany

Location

Charité Berlin, Campus Benjamin Franklin

Berlin, 12200, Germany

Location

Heart Center Bernau - Brandenburg

Bernau, 16321, Germany

Location

Herzzentrum Cottbus

Cottbus, 03048, Germany

Location

Klinikum Lippe-Detmold

Detmold, 32756, Germany

Location

Krankenhaus Fulda

Fulda, 36043, Germany

Location

University Greifswald

Greifswald, 17475, Germany

Location

Martin-Luther-Universität Halle-Wittenberg

Halle, 06097, Germany

Location

SLK-Kliniken Heilbronn

Heilbronn, 74078, Germany

Location

Oberhavel-Kliniken Hennigsdorf

Hennigsdorf, 16761, Germany

Location

Klinikum der Universität Jena

Jena, 07747, Germany

Location

Asklepios Klinik Langen

Langen, 63225, Germany

Location

University of Leipzig - Heart Center

Leipzig, 04289, Germany

Location

Klinikum der Stadt Ludwigshafen am Rhein

Ludwigshafen, 67063, Germany

Location

University of Lübeck

Lübeck, 23538, Germany

Location

Otto-von-Guericke University Magdeburg

Magdeburg, 39120, Germany

Location

German Heart Center Munich

Munich, 80636, Germany

Location

Krankenhaus der Barmherzigen Brüder

Regensburg, 93049, Germany

Location

Related Publications (16)

  • Lehrke M, Fuernau G, Jung C, Kahles F, Moellmann J, Eitel I, Thelemann N, Desch S, Werdan K, Zeymer U, Adams V, Marx N, Thiele H. GLP-1 in patients with myocardial infarction complicated by cardiogenic shock-an IABP-SHOCK II-substudy. Clin Res Cardiol. 2024 Aug;113(8):1211-1218. doi: 10.1007/s00392-023-02366-2. Epub 2024 Jan 3.

    PMID: 38170249DERIVED

  • Ceglarek U, Schellong P, Rosolowski M, Scholz M, Willenberg A, Kratzsch J, Zeymer U, Fuernau G, de Waha-Thiele S, Buttner P, Jobs A, Freund A, Desch S, Feistritzer HJ, Isermann B, Thiery J, Poss J, Thiele H. The novel cystatin C, lactate, interleukin-6, and N-terminal pro-B-type natriuretic peptide (CLIP)-based mortality risk score in cardiogenic shock after acute myocardial infarction. Eur Heart J. 2021 Jun 21;42(24):2344-2352. doi: 10.1093/eurheartj/ehab110.

    PMID: 33647946DERIVED

  • Fuernau G, Desch S, de Waha-Thiele S, Eitel I, Neumann FJ, Hennersdorf M, Felix SB, Fach A, Bohm M, Poss J, Jung C, Ouarrak T, Schneider S, Werdan K, Zeymer U, Thiele H. Arterial Lactate in Cardiogenic Shock: Prognostic Value of Clearance Versus Single Values. JACC Cardiovasc Interv. 2020 Oct 12;13(19):2208-2216. doi: 10.1016/j.jcin.2020.06.037.

    PMID: 33032708DERIVED

  • 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: 30586721DERIVED

  • Poss J, Koster J, Fuernau G, Eitel I, de Waha S, Ouarrak T, Lassus J, Harjola VP, Zeymer U, Thiele H, Desch S. Risk Stratification for Patients in Cardiogenic Shock After Acute Myocardial Infarction. J Am Coll Cardiol. 2017 Apr 18;69(15):1913-1920. doi: 10.1016/j.jacc.2017.02.027.

    PMID: 28408020DERIVED

  • Ledwoch J, Fuernau G, Desch S, Eitel I, Jung C, de Waha S, Poess J, Schneider S, Schuler G, Werdan K, Zeymer U, Thiele H. Drug-eluting stents versus bare-metal stents in acute myocardial infarction with cardiogenic shock. Heart. 2017 Aug;103(15):1177-1184. doi: 10.1136/heartjnl-2016-310403. Epub 2017 Feb 7.

    PMID: 28174212DERIVED

  • Jung C, Fuernau G, Eitel I, Desch S, Schuler G, Kelm M, Adams V, Thiele H. Incidence, laboratory detection and prognostic relevance of hypoxic hepatitis in cardiogenic shock. Clin Res Cardiol. 2017 May;106(5):341-349. doi: 10.1007/s00392-016-1060-3. Epub 2016 Dec 8.

    PMID: 27928583DERIVED

  • Zeymer U, Werdan K, Schuler G, Zahn R, Neumann FJ, Furnau G, de Waha S, Schneider S, Thiele H. Editor's Choice- Impact of immediate multivessel percutaneous coronary intervention versus culprit lesion intervention on 1-year outcome in patients with acute myocardial infarction complicated by cardiogenic shock: Results of the randomised IABP-SHOCK II trial. Eur Heart J Acute Cardiovasc Care. 2017 Oct;6(7):601-609. doi: 10.1177/2048872616668977. Epub 2016 Sep 21.

    PMID: 27655918DERIVED

  • Poss J, Fuernau G, Denks D, Desch S, Eitel I, de Waha S, Link A, Schuler G, Adams V, Bohm M, Thiele H. Angiopoietin-2 in acute myocardial infarction complicated by cardiogenic shock--a biomarker substudy of the IABP-SHOCK II-Trial. Eur J Heart Fail. 2015 Nov;17(11):1152-60. doi: 10.1002/ejhf.342. Epub 2015 Sep 3.

    PMID: 26333723DERIVED

  • Jung C, Fuernau G, de Waha S, Eitel I, Desch S, Schuler G, Figulla HR, Thiele H. Intraaortic balloon counterpulsation and microcirculation in cardiogenic shock complicating myocardial infarction: an IABP-SHOCK II substudy. Clin Res Cardiol. 2015 Aug;104(8):679-87. doi: 10.1007/s00392-015-0833-4. Epub 2015 Feb 27.

    PMID: 25720332DERIVED

  • Jung C, Fuernau G, Muench P, Desch S, Eitel I, Schuler G, Adams V, Figulla HR, Thiele H. Impairment of the endothelial glycocalyx in cardiogenic shock and its prognostic relevance. Shock. 2015 May;43(5):450-5. doi: 10.1097/SHK.0000000000000329.

    PMID: 25692257DERIVED

  • Schuster A, Faulkner M, Zeymer U, Ouarrak T, Eitel I, Desch S, Hasenfuss G, Thiele H. Economic implications of intra-aortic balloon support for myocardial infarction with cardiogenic shock: an analysis from the IABP-SHOCK II-trial. Clin Res Cardiol. 2015 Jul;104(7):566-73. doi: 10.1007/s00392-015-0819-2. Epub 2015 Jan 31.

    PMID: 25637294DERIVED

  • Fuernau G, Poss J, Denks D, Desch S, Heine GH, Eitel I, Seiler S, de Waha S, Ewen S, Link A, Schuler G, Adams V, Bohm M, Thiele H. Fibroblast growth factor 23 in acute myocardial infarction complicated by cardiogenic shock: a biomarker substudy of the Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial. Crit Care. 2014 Dec 21;18(6):713. doi: 10.1186/s13054-014-0713-8.

    PMID: 25528363DERIVED

  • Fuernau G, Poenisch C, Eitel I, de Waha S, Desch S, Schuler G, Adams V, Werdan K, Zeymer U, Thiele H. Growth-differentiation factor 15 and osteoprotegerin in acute myocardial infarction complicated by cardiogenic shock: a biomarker substudy of the IABP-SHOCK II-trial. Eur J Heart Fail. 2014 Aug;16(8):880-7. doi: 10.1002/ejhf.117. Epub 2014 Jun 5.

    PMID: 24903195DERIVED

  • 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: 24011548DERIVED

  • 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: 22920912DERIVED

MeSH Terms

Conditions

Myocardial InfarctionShock, Cardiogenic

Interventions

Intra-Aortic Balloon Pumping

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Intervention Hierarchy (Ancestors)

CounterpulsationAssisted CirculationSurgical Procedures, Operative

Study Officials

  • Holger Thiele, MD

    Heart Center Leipzig - University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director

Study Record Dates

First Submitted

June 22, 2007

First Posted

June 25, 2007

Study Start

June 1, 2009

Primary Completion

June 1, 2012

Study Completion

October 1, 2016

Last Updated

May 2, 2017

Record last verified: 2017-05

Locations

DE(20)