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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraaortic balloon pump | Active Comparator | Patients in cardiogenic shock get an intraaortic balloon pump in the cath lab |
|
| No intraaortic balloon pump | No Intervention | Patients in cardiogenic shock in this group get no intraaortic balloon pump |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraaortic balloon pump | Device | intraaortic balloon pump from Datascope/Maquet or Arrow/Teleflex will be used |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30-day mortality | 30 day |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory markers (CRP and white blood cell count) | 4 days | |
| Hemodynamic Parameters (Blood pressure, Heart rate) | 3 days | |
| Time till hemodynamic stabilization |
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Inclusion Criteria:
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:
Informed consent
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holger Thiele, MD | Heart Center Leipzig - University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zentralklinik Bad Berka GmbH | Bad Berka | 99437 | Germany | |||
| Herzzentrum Bad Krozingen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38170249 | Derived | 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. | |
| 33647946 |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Not provided
| ID | Term |
|---|---|
| D007423 | Intra-Aortic Balloon Pumping |
| ID | Term |
|---|---|
| D015908 | Counterpulsation |
| D001243 | Assisted Circulation |
| D013514 | Surgical Procedures, Operative |
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| 30 days |
| Catecholamine dose and duration of catecholamines | 30 days |
| Mean and area under the curve of serum lactate | 48 hours |
| Creatinine clearance until stabilization | 4 days |
| requirement for hemofiltration or dialysis | 4 days |
| length of ICU stay | 30 days |
| length of mechanical ventilation | 30 days |
| SAPS-II Score | 4 days |
| requirement for active assist device implantation or heart transplantation at 30 days and approximately 60 months | 60 months |
| long-term mortality at 6, 12 and approximately 60 months | 60 months |
| quality of life at 30 days and approximately 60 months | 60 months |
| Bad Krozingen |
| 79189 |
| Germany |
| Segeberger Kliniken Gmbh | Bad Segeberg | 23795 | Germany |
| Charité Berlin, Campus Benjamin Franklin | Berlin | 12200 | Germany |
| Heart Center Bernau - Brandenburg | Bernau | 16321 | Germany |
| Herzzentrum Cottbus | Cottbus | 03048 | Germany |
| Klinikum Lippe-Detmold | Detmold | 32756 | Germany |
| Krankenhaus Fulda | Fulda | 36043 | Germany |
| University Greifswald | Greifswald | 17475 | Germany |
| Martin-Luther-Universität Halle-Wittenberg | Halle | 06097 | Germany |
| SLK-Kliniken Heilbronn | Heilbronn | 74078 | Germany |
| Oberhavel-Kliniken Hennigsdorf | Hennigsdorf | 16761 | Germany |
| Klinikum der Universität Jena | Jena | 07747 | Germany |
| Asklepios Klinik Langen | Langen | 63225 | Germany |
| University of Leipzig - Heart Center | Leipzig | 04289 | Germany |
| Klinikum der Stadt Ludwigshafen am Rhein | Ludwigshafen | 67063 | Germany |
| University of Lübeck | Lübeck | 23538 | Germany |
| Otto-von-Guericke University Magdeburg | Magdeburg | 39120 | Germany |
| German Heart Center Munich | Munich | 80636 | Germany |
| Krankenhaus der Barmherzigen Brüder | Regensburg | 93049 | Germany |
| 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. |
| 33032708 | Derived | 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. |
| 30586721 | Derived | 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. |
| 28408020 | Derived | 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. |
| 28174212 | Derived | 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. |
| 27928583 | Derived | 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. |
| 27655918 | Derived | 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. |
| 26333723 | Derived | 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. |
| 25720332 | Derived | 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. |
| 25692257 | Derived | 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. |
| 25637294 | Derived | 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. |
| 25528363 | Derived | 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. |
| 24903195 | Derived | 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. |
| 24011548 | Derived | 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. |
| 22920912 | Derived | 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. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |