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

November 7, 2017 updated by: Holger Thiele, University of Luebeck

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

706

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Goettingen, Germany
        • University of Goettingen
      • Leipzig, Germany, 04289
        • University of Leipzig - Heart Center
      • Leipzig, Germany, 04289
        • Heart Center Leipzig - University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
30-day mortality and/or severe renal failure requiring renal replacement therapy
Time Frame: 30 days
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Luebeck

Collaborators

European Commission
Deutsche Stiftung für Herzforschung
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
German Cardiac Society

Investigators

  • Study Chair: Holger Thiele, MD, Heart Center Leipzig - University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

August 14, 2013

First Submitted That Met QC Criteria

August 19, 2013

First Posted (Estimate)

August 22, 2013

Study Record Updates

Last Update Posted (Actual)

November 9, 2017

Last Update Submitted That Met QC Criteria

November 7, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CULPRIT-SHOCK1.2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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