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Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock (CULPRIT-SHOCK)

Primary Purpose

Cardiogenic Shock, Acute Myocardial Infarction, Complications

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Immediate multivessel PCI
Culprit Lesion only PCI
Sponsored by
University of Luebeck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiogenic Shock focused on measuring cardiogenic shock, infarction, multivessel coronary artery disease, angioplasty

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

  1. Systolic blood pressure less than 90 mmHg for more than 30 min or
  2. 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • University of Goettingen
  • Heart Center Leipzig - University Hospital
  • University of Leipzig - Heart Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Immediate multivessel PCI

Culprit lesion only PCI

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

30-day mortality
Requirement of renal replacement therapy
Time to hemodynamic stabilization
Duration of catecholamine therapy
Serial creatinine-level creatinine-clearance
Length of ICU-stay
Serial intensive care scoring (SAPS-II score) until stabilization
Requirement and length of mechanical ventilation
All-cause death within 12 months follow-up
Recurrent infarction within 30-days follow-up
Death or recurrent infarction at 12 months follow-up
Rehospitalization for congestive heart failure within 12 months follow-up
Death/recurrent infarction/rehospitalization for congestive heart failure within 12 months
Need for repeat revascularization (PCI and/or CABG) within 12 months follow-up
Peak creatine kinase level during hospital stay
Quality of life at 6 and 12 months assessed using Euroqol 5D (EQ-5D)
Maximum creatine kinase-MB level
Maximum troponin level
Recurrent infarction within 12 months follow-up

Full Information

First Posted
August 14, 2013
Last Updated
November 7, 2017
Sponsor
University of Luebeck
Collaborators
European Commission, German Cardiac Society, Deutsche Stiftung für Herzforschung, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
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1. Study Identification

Unique Protocol Identification Number
NCT01927549
Brief Title
Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock
Acronym
CULPRIT-SHOCK
Official Title
Prospective Randomized Multicenter Study Comparing Immediate Multivessel Revascularization by PCI Versus Culprit Lesion PCI With Staged Non-culprit Lesion Revascularization in Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Luebeck
Collaborators
European Commission, German Cardiac Society, Deutsche Stiftung für Herzforschung, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiogenic Shock, Acute Myocardial Infarction, Complications
Keywords
cardiogenic shock, infarction, multivessel coronary artery disease, angioplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
706 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate multivessel PCI
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Culprit lesion only PCI
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Immediate multivessel PCI
Intervention Type
Procedure
Intervention Name(s)
Culprit Lesion only PCI
Primary Outcome Measure Information:
Title
30-day mortality and/or severe renal failure requiring renal replacement therapy
Time Frame
30 days
Secondary Outcome Measure Information:
Title
30-day mortality
Time Frame
30 days
Title
Requirement of renal replacement therapy
Time Frame
30 days
Title
Time to hemodynamic stabilization
Time Frame
30 days
Title
Duration of catecholamine therapy
Time Frame
30 days
Title
Serial creatinine-level creatinine-clearance
Time Frame
30 days
Title
Length of ICU-stay
Time Frame
30 days
Title
Serial intensive care scoring (SAPS-II score) until stabilization
Time Frame
30 days
Title
Requirement and length of mechanical ventilation
Time Frame
30 days
Title
All-cause death within 12 months follow-up
Time Frame
12 months
Title
Recurrent infarction within 30-days follow-up
Time Frame
30 days
Title
Death or recurrent infarction at 12 months follow-up
Time Frame
12 months
Title
Rehospitalization for congestive heart failure within 12 months follow-up
Time Frame
12 months
Title
Death/recurrent infarction/rehospitalization for congestive heart failure within 12 months
Time Frame
12 months
Title
Need for repeat revascularization (PCI and/or CABG) within 12 months follow-up
Time Frame
12 months
Title
Peak creatine kinase level during hospital stay
Time Frame
30 days
Title
Quality of life at 6 and 12 months assessed using Euroqol 5D (EQ-5D)
Time Frame
12 months
Title
Maximum creatine kinase-MB level
Time Frame
30 days
Title
Maximum troponin level
Time Frame
30 days
Title
Recurrent infarction within 12 months follow-up
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger Thiele, MD
Organizational Affiliation
Heart Center Leipzig - University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
University of Goettingen
City
Goettingen
Country
Germany
Facility Name
Heart Center Leipzig - University Hospital
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
University of Leipzig - Heart Center
City
Leipzig
ZIP/Postal Code
04289
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
36229091
Citation
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.
Results Reference
derived
PubMed Identifier
33647946
Citation
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.
Results Reference
derived
PubMed Identifier
32894227
Citation
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.
Results Reference
derived
PubMed Identifier
32883104
Citation
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.
Results Reference
derived
PubMed Identifier
32845312
Citation
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.
Results Reference
derived
PubMed Identifier
32151161
Citation
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.
Results Reference
derived
PubMed Identifier
31167601
Citation
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.
Results Reference
derived
PubMed Identifier
30145971
Citation
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.
Results Reference
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PubMed Identifier
29083953
Citation
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.
Results Reference
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PubMed Identifier
28821512
Citation
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.
Results Reference
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PubMed Identifier
26856228
Citation
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.
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Results Reference
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Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock

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