Trial record 2 of 59 for:    cardiogenic shock

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Luebeck
Sponsor:
Collaborators:
European Commission
German Cardiac Society
German Heart Research Foundation
Information provided by (Responsible Party):
Holger Thiele, University of Luebeck
ClinicalTrials.gov Identifier:
NCT01927549
First received: August 14, 2013
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Cardiogenic Shock
Acute Myocardial Infarction
Complications
Procedure: Immediate multivessel PCI
Procedure: Culprit Lesion only PCI
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • 30-day mortality and/or severe renal failure requiring renal replacement therapy [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 30-day mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Requirement of renal replacement therapy [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Time to hemodynamic stabilization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Duration of catecholamine therapy [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Serial creatinine-level creatinine-clearance [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Length of ICU-stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Serial intensive care scoring (SAPS-II score) until stabilization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Requirement and length of mechanical ventilation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • All-cause death within 12 months follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Recurrent infarction within 30-days follow-up [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Death or recurrent infarction at 12 months follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rehospitalization for congestive heart failure within 12 months follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Death/recurrent infarction/rehospitalization for congestive heart failure within 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Need for repeat revascularization (PCI and/or CABG) within 12 months follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Peak creatine kinase level during hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Quality of life at 6 and 12 months assessed using Euroqol 5D (EQ-5D) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Maximum creatine kinase-MB level [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Maximum troponin level [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Recurrent infarction within 12 months follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 706
Study Start Date: April 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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).
Procedure: Culprit Lesion only PCI

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

  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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01927549

Contacts
Contact: Holger Thiele, MD 00494515002501 holger.thiele@uksh.de

Locations
Germany
University of Goettingen Recruiting
Goettingen, Germany
Contact: Gerd Hasenfuss         
Principal Investigator: Gerd Hasenfuss         
University of Leipzig - Heart Center Recruiting
Leipzig, Germany, 04289
Contact: Gerhard Schuler, MD    00493418651428    gerhard.schuler@med.uni-leipzig.de   
Sub-Investigator: Georg Fuernau, MD         
Principal Investigator: Gerhard Schuler, MD         
University of Luebeck Recruiting
Luebeck, Germany, 23538
Contact: Holger Thiele       holger.thiele@uksh.de   
Contact: Renate Domeier       renate.domeier@uksh.de   
Sub-Investigator: Steffen Desch         
Principal Investigator: Holger Thiele         
Sub-Investigator: Kai Mortensen         
Sponsors and Collaborators
University of Luebeck
European Commission
German Cardiac Society
German Heart Research Foundation
Investigators
Study Chair: Holger Thiele, MD University of Leipzig
  More Information

Additional Information:
No publications provided

Responsible Party: Holger Thiele, Coordinator, University of Luebeck
ClinicalTrials.gov Identifier: NCT01927549     History of Changes
Other Study ID Numbers: CULPRIT-SHOCK1.2
Study First Received: August 14, 2013
Last Updated: March 3, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University of Luebeck:
cardiogenic shock
infarction
multivessel coronary artery disease
angioplasty

Additional relevant MeSH terms:
Shock
Shock, Cardiogenic
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 28, 2014