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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01927549
Recruitment Status : Completed
First Posted : August 22, 2013
Last Update Posted : November 9, 2017
Sponsor:
Collaborators:
European Commission
German Cardiac Society
Deutsche Stiftung für Herzforschung
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Information provided by (Responsible Party):
Holger Thiele, Heart Center Leipzig - University Hospital

Tracking Information
First Submitted Date  ICMJE August 14, 2013
First Posted Date  ICMJE August 22, 2013
Last Update Posted Date November 9, 2017
Study Start Date  ICMJE April 2013
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2013)
30-day mortality and/or severe renal failure requiring renal replacement therapy [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2013)
  • 30-day mortality [ Time Frame: 30 days ]
  • Requirement of renal replacement therapy [ Time Frame: 30 days ]
  • Time to hemodynamic stabilization [ Time Frame: 30 days ]
  • Duration of catecholamine therapy [ Time Frame: 30 days ]
  • Serial creatinine-level creatinine-clearance [ Time Frame: 30 days ]
  • Length of ICU-stay [ Time Frame: 30 days ]
  • Serial intensive care scoring (SAPS-II score) until stabilization [ Time Frame: 30 days ]
  • Requirement and length of mechanical ventilation [ Time Frame: 30 days ]
  • All-cause death within 12 months follow-up [ Time Frame: 12 months ]
  • Recurrent infarction within 30-days follow-up [ Time Frame: 30 days ]
  • Death or recurrent infarction at 12 months follow-up [ Time Frame: 12 months ]
  • Rehospitalization for congestive heart failure within 12 months follow-up [ Time Frame: 12 months ]
  • Death/recurrent infarction/rehospitalization for congestive heart failure within 12 months [ Time Frame: 12 months ]
  • Need for repeat revascularization (PCI and/or CABG) within 12 months follow-up [ Time Frame: 12 months ]
  • Peak creatine kinase level during hospital stay [ Time Frame: 30 days ]
  • Quality of life at 6 and 12 months assessed using Euroqol 5D (EQ-5D) [ Time Frame: 12 months ]
  • Maximum creatine kinase-MB level [ Time Frame: 30 days ]
  • Maximum troponin level [ Time Frame: 30 days ]
  • Recurrent infarction within 12 months follow-up [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiogenic Shock
  • Acute Myocardial Infarction
  • Complications
Intervention  ICMJE
  • Procedure: Immediate multivessel PCI
  • Procedure: Culprit Lesion only PCI
Study Arms  ICMJE
  • Active Comparator: Immediate multivessel PCI
    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.
    Intervention: Procedure: Immediate multivessel PCI
  • Active Comparator: Culprit lesion only PCI
    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: Procedure: Culprit Lesion only PCI
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2013)
706
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01927549
Other Study ID Numbers  ICMJE CULPRIT-SHOCK1.2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Holger Thiele, Heart Center Leipzig - University Hospital
Study Sponsor  ICMJE University of Luebeck
Collaborators  ICMJE
  • European Commission
  • German Cardiac Society
  • Deutsche Stiftung für Herzforschung
  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Investigators  ICMJE
Study Chair: Holger Thiele, MD Heart Center Leipzig - University Hospital
PRS Account University of Luebeck
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP