NCT01927549

Brief Summary

The study compares the therapies of instant multivessel balloon angioplasty plus stent implantation or the balloon angioplasty plus stent implantation of the infarct artery alone with any possible graduated later treatment of the other vessels in patients with acute myocardial infarction with cardioganic shock. The main study hypothesis is to explore if culprit vessel only PCI with potentially subsequent staged revascularization in comparison to immediate multivessel revascularization by PCI in patients with cardiogenic shock complicating acute myocardial infarction reduces the incidence of 30- day mortality and/or severe renal failure requiring renal replacement therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
706

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2013

Longer than P75 for phase_4

Geographic Reach
1 country

3 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

Study Start

First participant enrolled

April 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 22, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

4.3 years

First QC Date

August 14, 2013

Last Update Submit

November 7, 2017

Conditions

Cardiogenic ShockAcute Myocardial InfarctionComplications

Keywords

cardiogenic shockinfarctionmultivessel coronary artery diseaseangioplasty

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality and/or severe renal failure requiring renal replacement therapy

    30 days

Secondary Outcomes (19)

  • 30-day mortality

    30 days

  • Requirement of renal replacement therapy

    30 days

  • Time to hemodynamic stabilization

    30 days

  • Duration of catecholamine therapy

    30 days

  • Serial creatinine-level creatinine-clearance

    30 days

  • +14 more secondary outcomes

Study Arms (2)

Immediate multivessel PCI

ACTIVE COMPARATOR

After diagnostic angiography the culprit lesion is identified and PCI should be performed using standard techniques. The use of drug-eluting stents is recommended but not mandatory. All additional lesions in other major coronary arteries defined by a diameter \>2 mm with high grade stenoses (\>70% by visual assessment) should be intervened using standard techniques. Other major coronary arteries are defined by stenoses of other vessels and are not confined to a diagonal branch if the left anterior descending coronary artery was identified as the culprit lesion.

Procedure: Immediate multivessel PCI

Culprit lesion only PCI

ACTIVE COMPARATOR

After diagnostic angiography the culprit lesion is identified and PCI of the culprit lesion should be performed using standard techniques. The use of drug-eluting stents is recommended but not mandatory. All other lesions should be left untreated in the acute setting. Complete revascularization of the non-culprit lesions may be performed at a later time point as staged procedure depending on remaining ischemia (as per guideline recommendations either by PCI or CABG).

Procedure: Culprit Lesion only PCI

Interventions

Immediate multivessel PCIPROCEDURE
Immediate multivessel PCI
Culprit Lesion only PCIPROCEDURE
Culprit lesion only PCI

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 infarction (STEMI or NSTEMI) with obligatory:
  • I) Planned early revascularization by PCI II) Multivessel coronary artery disease defined as more than 70% stenosis in at least 2 major vessels (more than 2 mm diameter) with identifiable culprit lesion III)
  • Systolic blood pressure less than 90 mmHg for more than 30 min or
  • catecholamines required to maintain pressure more than 90 mmHg during systole and IV) Signs of pulmonary congestion V) Signs of impaired organ perfusion with at least one of the following criteria
  • a) Altered mental status b) Cold, clammy skin and extremities c) Oliguria with urine output less than 30 ml/h d) Serum-lactate more than 2.0 mmol/l VI) Informed consent

You may not qualify if:

  • Resuscitation more than 30 minutes
  • No intrinsic heart action
  • Cerebral deficit with fixed dilated pupils (not drug-induced)
  • Need for primary urgent bypass surgery (to be determined after diagnostic angiography)
  • Single vessel disease
  • Mechanical cause of cardiogenic shock
  • Onset of shock more than 12 h
  • Massive lung emboli
  • Age more than 90 years
  • Shock of other cause (bradycardia, sepsis, hypovolemia, etc.)
  • Other severe concomitant disease with limited life expectancy \<6 months
  • Pregnancy
  • Known severe renal insufficiency (creatinine clearance \<30 ml/kg)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Goettingen

Göttingen, Germany

Location

Heart Center Leipzig - University Hospital

Leipzig, 04289, Germany

Location

University of Leipzig - Heart Center

Leipzig, 04289, Germany

Location

Related Publications (15)

  • Jung C, Lang A, Duse DA, Bruno RR, Poss J, Wolff G, Ceglarek U, Zeymer U, Fuernau G, Zweck E, Desch S, Freund A, Isermann B, Pfeiler S, Wernly B, Kelm M, Thiele H, Gerdes N. Plasma Proteome Analysis Identifies Vascular Endothelial Growth Factor Receptor 1 as a Prognostic Biomarker in Cardiogenic Shock. Circ Heart Fail. 2025 Dec;18(12):e012890. doi: 10.1161/CIRCHEARTFAILURE.125.012890. Epub 2025 Oct 1.

    PMID: 41031405DERIVED

  • Zeymer-von Metnitz D, Ouarrak T, Huber K, Noc M, Desch S, Freund A, Zeymer U, Thiele H, Poss J. Mild Induced Hypothermia in Patients with Infarct-Related Cardiogenic Shock and Cardiac Arrest: Insights from the CULPRIT-SHOCK Trial. Eur Heart J Acute Cardiovasc Care. 2025 Sep 23:zuaf124. doi: 10.1093/ehjacc/zuaf124. Online ahead of print.

    PMID: 40986817DERIVED

  • Zeymer U, Alushi B, Noc M, Mamas MA, Montalescot G, Fuernau G, Huber K, Poess J, de Waha-Thiele S, Schneider S, Ouarrak T, Desch S, Lauten A, Thiele H. Influence of Culprit Lesion Intervention on Outcomes in Infarct-Related Cardiogenic Shock With Cardiac Arrest. J Am Coll Cardiol. 2023 Mar 28;81(12):1165-1176. doi: 10.1016/j.jacc.2023.01.029.

    PMID: 36948733DERIVED

  • Bohme M, Desch S, Rosolowski M, Scholz M, Krohn K, Buttner P, Cross M, Kirchberg J, Rommel KP, Poss J, Freund A, Baber R, Isermann B, Ceglarek U, Metzeler KH, Platzbecker U, Thiele H. Impact of Clonal Hematopoiesis in Patients With Cardiogenic Shock Complicating Acute Myocardial Infarction. J Am Coll Cardiol. 2022 Oct 18;80(16):1545-1556. doi: 10.1016/j.jacc.2022.08.740.

    PMID: 36229091DERIVED

  • 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

  • Hauguel-Moreau M, Barthelemy O, Farhan S, Huber K, Rouanet S, Zeitouni M, Guedeney P, Hage G, Vicaut E, Zeymer U, Desch S, Thiele H, Montalescot G. Culprit lesion location and outcomes in patients with multivessel disease and infarct-related cardiogenic shock: a core laboratory analysis of the CULPRIT-SHOCK trial. EuroIntervention. 2021 Aug 6;17(5):e418-e424. doi: 10.4244/EIJ-D-20-00561.

    PMID: 32894227DERIVED

  • Sag CM, Zeymer U, Ouarrak T, Schneider S, Montalescot G, Huber K, Fuernau G, Freund A, Feistritzer HJ, Desch S, Thiele H, Maier LS. Effects of ON-Hours Versus OFF-Hours Admission on Outcome in Patients With Myocardial Infarction and Cardiogenic Shock: Results From the CULPRIT-SHOCK Trial. Circ Cardiovasc Interv. 2020 Sep;13(9):e009562. doi: 10.1161/CIRCINTERVENTIONS.120.009562. Epub 2020 Sep 4.

    PMID: 32883104DERIVED

  • Farhan S, Vogel B, Montalescot G, Barthelemy O, Zeymer U, Desch S, de Waha-Thiele S, Maier LS, Sandri M, Akin I, Fuernau G, Ouarrak T, Hauguel-Moreau M, Schneider S, Thiele H, Huber K. Association of Culprit Lesion Location With Outcomes of Culprit-Lesion-Only vs Immediate Multivessel Percutaneous Coronary Intervention in Cardiogenic Shock: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2020 Dec 1;5(12):1329-1337. doi: 10.1001/jamacardio.2020.3377.

    PMID: 32845312DERIVED

  • Rubini Gimenez M, Zeymer U, Desch S, de Waha-Thiele S, Ouarrak T, Poess J, Meyer-Saraei R, Schneider S, Fuernau G, Stepinska J, Huber K, Windecker S, Montalescot G, Savonitto S, Jeger RV, Thiele H. Sex-Specific Management in Patients With Acute Myocardial Infarction and Cardiogenic Shock: A Substudy of the CULPRIT-SHOCK Trial. Circ Cardiovasc Interv. 2020 Mar;13(3):e008537. doi: 10.1161/CIRCINTERVENTIONS.119.008537. Epub 2020 Mar 10.

    PMID: 32151161DERIVED

  • Feistritzer HJ, Desch S, Zeymer U, Fuernau G, de Waha-Thiele S, Dudek D, Huber K, Stepinska J, Schneider S, Ouarrak T, Thiele H. Prognostic Impact of Atrial Fibrillation in Acute Myocardial Infarction and Cardiogenic Shock. Circ Cardiovasc Interv. 2019 Jun;12(6):e007661. doi: 10.1161/CIRCINTERVENTIONS.118.007661. Epub 2019 Jun 6.

    PMID: 31167601DERIVED

  • Thiele H, Akin I, Sandri M, de Waha-Thiele S, Meyer-Saraei R, Fuernau G, Eitel I, Nordbeck P, Geisler T, Landmesser U, Skurk C, Fach A, Jobs A, Lapp H, Piek JJ, Noc M, Goslar T, Felix SB, Maier LS, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Barthelemy O, Huber K, Windecker S, Hunziker L, Savonitto S, Torremante P, Vrints C, Schneider S, Zeymer U, Desch S; CULPRIT-SHOCK Investigators. One-Year Outcomes after PCI Strategies in Cardiogenic Shock. N Engl J Med. 2018 Nov 1;379(18):1699-1710. doi: 10.1056/NEJMoa1808788. Epub 2018 Aug 25.

    PMID: 30145971DERIVED

  • Thiele H, Akin I, Sandri M, Fuernau G, de Waha S, Meyer-Saraei R, Nordbeck P, Geisler T, Landmesser U, Skurk C, Fach A, Lapp H, Piek JJ, Noc M, Goslar T, Felix SB, Maier LS, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Barthelemy O, Huber K, Windecker S, Savonitto S, Torremante P, Vrints C, Schneider S, Desch S, Zeymer U; CULPRIT-SHOCK Investigators. PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock. N Engl J Med. 2017 Dec 21;377(25):2419-2432. doi: 10.1056/NEJMoa1710261. Epub 2017 Oct 30.

    PMID: 29083953DERIVED

  • Quayyum Z, Briggs A, Robles-Zurita J, Oldroyd K, Zeymer U, Desch S, Waha S, Thiele H. Protocol for an economic evaluation of the randomised controlled trial of culprit lesion only PCI versus immediate multivessel PCI in acute myocardial infarction complicated by cardiogenic shock: CULPRIT-SHOCK trial. BMJ Open. 2017 Aug 18;7(8):e014849. doi: 10.1136/bmjopen-2016-014849.

    PMID: 28821512DERIVED

  • Thiele H, Desch S, Piek JJ, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Noc M, Huber K, Fuernau G, de Waha S, Meyer-Saraei R, Schneider S, Windecker S, Savonitto S, Briggs A, Torremante P, Vrints C, Schuler G, Ceglarek U, Thiery J, Zeymer U; CULPRIT-SHOCK Investigators. Multivessel versus culprit lesion only percutaneous revascularization plus potential staged revascularization in patients with acute myocardial infarction complicated by cardiogenic shock: Design and rationale of CULPRIT-SHOCK trial. Am Heart J. 2016 Feb;172:160-9. doi: 10.1016/j.ahj.2015.11.006. Epub 2015 Dec 1.

    PMID: 26856228DERIVED

  • AbouEzzeddine OF, Lala A, Khazanie PP, Shah R, Ho JE, Chen HH, Pang PS, McNulty SE, Anstrom KJ, Hernandez AF, Redfield MM; NHLBI Heart Failure Clinical Research Network. Evaluation of a provocative dyspnea severity score in acute heart failure. Am Heart J. 2016 Feb;172:34-41. doi: 10.1016/j.ahj.2015.10.009. Epub 2015 Oct 20.

    PMID: 26856213DERIVED

MeSH Terms

Conditions

Shock, CardiogenicInfarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

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
Coordinator

Study Record Dates

First Submitted

August 14, 2013

First Posted

August 22, 2013

Study Start

April 1, 2013

Primary Completion

July 1, 2017

Study Completion

October 1, 2017

Last Updated

November 9, 2017

Record last verified: 2017-11

Locations

DE(3)