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Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock

NCT01927549 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 706

Last updated 2017-11-09

No results posted yet for this study

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.

Conditions

  • Cardiogenic Shock
  • Acute Myocardial Infarction
  • Complications

Interventions

PROCEDURE

Immediate multivessel PCI

PROCEDURE

Culprit Lesion only PCI

Sponsors & Collaborators

  • European Commission

    collaborator OTHER

  • German Cardiac Society

    collaborator OTHER

  • Deutsche Stiftung für Herzforschung

    collaborator OTHER

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

    collaborator OTHER

  • University of Luebeck

    lead OTHER

Principal Investigators

  • Holger Thiele, MD · Heart Center Leipzig - University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2017-07-31
Completion
2017-10-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01927549 on ClinicalTrials.gov