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Myocardial InfarctionPhase 4IABP-SHOCK IINCT00491036

Intraaortic Balloon Pump in Cardiogenic Shock II

A Phase 4 study testing Intraaortic balloon pump in people with Myocardial Infarction and Shock, Cardiogenic, run by University of Leipzig at 20 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Myocardial Infarction, Shock, Cardiogenic
What is being tested?
Intraaortic balloon pump
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
20 sitesGermany
Study dates
Jun 2009to Oct 2016
Phase
Phase 4
Are there results?
None posted in the registry

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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • Cold, clammy skin
  • Urine output <30 ml/h
  • Serum lactate >2mmol/l
  • Informed consent

Who cannot join

  • 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
Show all 11Show fewer
  • Aortic regurgitation > II.°
  • Age > 90 years
  • shock of other cause
  • Other severe concomitant disease
  • participation in another trial

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Germany20 sites

  • Zentralklinik Bad Berka GmbH

    Bad Berka, 99437

  • Herzzentrum Bad Krozingen

    Bad Krozingen, 79189

  • Segeberger Kliniken Gmbh

    Bad Segeberg, 23795

  • Charité Berlin, Campus Benjamin Franklin

    Berlin, 12200

  • Heart Center Bernau - Brandenburg

    Bernau, 16321

  • Herzzentrum Cottbus

    Cottbus, 03048

  • Klinikum Lippe-Detmold

    Detmold, 32756

  • Krankenhaus Fulda

    Fulda, 36043

  • University Greifswald

    Greifswald, 17475

  • Martin-Luther-Universität Halle-Wittenberg

    Halle, 06097

  • SLK-Kliniken Heilbronn

    Heilbronn, 74078

  • Oberhavel-Kliniken Hennigsdorf

    Hennigsdorf, 16761

  • Klinikum der Universität Jena

    Jena, 07747

  • Asklepios Klinik Langen

    Langen, 63225

  • University of Leipzig - Heart Center

    Leipzig, 04289

  • University of Lübeck

    Lübeck, 23538

  • Klinikum der Stadt Ludwigshafen am Rhein

    Ludwigshafen, 67063

  • Otto-von-Guericke University Magdeburg

    Magdeburg, 39120

  • German Heart Center Munich

    Munich, 80636

  • Krankenhaus der Barmherzigen Brüder

    Regensburg, 93049

Other trials in Germany

About this study

Official title: Randomized Clinical Study of Intraaortic Balloon Pump Use in Cardiogenic Shock Complicating Acute Myocardial Infarction

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.

Being tested
Intraaortic balloon pump
Keywords
Acute myocardial infarction, cardiogenic shock, percutaneous coronary intervention, intraaortic balloon counterpulsation, Acute myocardial infarction - cardiogenic shock
Medical subject headings
Myocardial Infarction, Shock, Cardiogenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intraaortic balloon pumpDevice

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

Study groups in NCT00491036
Study groupRoleWhat they receive
Intraaortic balloon pumpActive comparatorPatients in cardiogenic shock get an intraaortic balloon pump in the cath lab
Receives: Device: Intraaortic balloon pump
No intraaortic balloon pumpNo interventionPatients in cardiogenic shock in this group get no intraaortic balloon pump

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30-day mortality

    Measured: 30 day

Secondary outcomes (13)

  1. Inflammatory markers (CRP and white blood cell count)

    Measured: 4 days

  2. Hemodynamic Parameters (Blood pressure, Heart rate)

    Measured: 3 days

  3. Time till hemodynamic stabilization

    Measured: 30 days

  4. Catecholamine dose and duration of catecholamines

    Measured: 30 days

  5. Mean and area under the curve of serum lactate

    Measured: 48 hours

  6. Creatinine clearance until stabilization

    Measured: 4 days

  7. requirement for hemofiltration or dialysis

    Measured: 4 days

  8. length of ICU stay

    Measured: 30 days

  9. length of mechanical ventilation

    Measured: 30 days

  10. SAPS-II Score

    Measured: 4 days

  11. requirement for active assist device implantation or heart transplantation at 30 days and approximately 60 months

    Measured: 60 months

  12. long-term mortality at 6, 12 and approximately 60 months

    Measured: 60 months

  13. quality of life at 30 days and approximately 60 months

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2007 (estimated)
  2. Study startJun 2009
  3. Primary completionJun 2012
  4. Study completionOct 2016

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00491036
Sponsor's protocol ID
342
Acronym
IABP-SHOCK II
Status last verified
May 2017
First submitted
22 Jun 2007
Last updated
2 May 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 38170249

  • 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.

    PubMed 33647946

  • 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.

    PubMed 33032708

  • 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.

    PubMed 30586721

  • 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.

    PubMed 28408020

  • 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.

    PubMed 28174212

  • 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.

    PubMed 27928583

  • 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.

    PubMed 27655918

  • 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.

    PubMed 26333723

  • 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.

    PubMed 25720332

  • 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.

    PubMed 25692257

  • 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.

    PubMed 25637294

  • 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.

    PubMed 25528363

  • 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.

    PubMed 24903195

  • 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.

    PubMed 24011548

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intraaortic balloon pump in people with Myocardial Infarction and Shock, Cardiogenic, run by University of Leipzig at 20 sites in Germany.

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 10 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: finished, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Germany. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

30-day mortality (time frame: 30 day). 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 NCT00491036, which also lists 16 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 2 May 2017.

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