Skip to main content
OpenTrials
Completed

NCT Number: NCT01927549

Culprit Lesion Only PCI Versus Multivessel PCI in 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Goettingen, Göttingen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Immediate multivessel PCI

Procedure

Culprit lesion only PCI

Procedure

Primary outcomes

  1. 30-day mortality and/or severe renal failure requiring renal replacement therapy

    Time frame: 30 days

Secondary outcomes

  1. 30-day mortality

    Time frame: 30 days

  2. Requirement of renal replacement therapy

    Time frame: 30 days

  3. Time to hemodynamic stabilization

    Time frame: 30 days

  4. Duration of catecholamine therapy

    Time frame: 30 days

  5. Serial creatinine-level creatinine-clearance

    Time frame: 30 days

  6. Length of ICU-stay

    Time frame: 30 days

  7. Serial intensive care scoring (SAPS-II score) until stabilization

    Time frame: 30 days

  8. Requirement and length of mechanical ventilation

    Time frame: 30 days

  9. All-cause death within 12 months follow-up

    Time frame: 12 months

  10. Recurrent infarction within 30-days follow-up

    Time frame: 30 days

  11. Death or recurrent infarction at 12 months follow-up

    Time frame: 12 months

  12. Rehospitalization for congestive heart failure within 12 months follow-up

    Time frame: 12 months

  13. Death/recurrent infarction/rehospitalization for congestive heart failure within 12 months

    Time frame: 12 months

  14. Need for repeat revascularization (PCI and/or CABG) within 12 months follow-up

    Time frame: 12 months

  15. Peak creatine kinase level during hospital stay

    Time frame: 30 days

  16. Quality of life at 6 and 12 months assessed using Euroqol 5D (EQ-5D)

    Time frame: 12 months

  17. Maximum creatine kinase-MB level

    Time frame: 30 days

  18. Maximum troponin level

    Time frame: 30 days

  19. Recurrent infarction within 12 months follow-up

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Collaborators

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

Registry information

Official study 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

Acronym: CULPRIT-SHOCK

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Aug 22, 2013
Registry last updated
Nov 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.