Design of DISCO-Direct or Subacute Coronary Angiography in Out-of-Hospital Cardiac Arrest study

Am Heart J. 2018 Mar:197:53-61. doi: 10.1016/j.ahj.2017.11.009. Epub 2017 Dec 5.

Abstract

Background: Acute coronary syndrome is a common cause of out-of-hospital cardiac arrest (OHCA). In patients with OHCA presenting with ST elevation, immediate coronary angiography and potential percutaneous coronary intervention (PCI) after return of spontaneous circulation are recommended. However, the evidence for this invasive strategy in patients without ST elevation is limited. Observational studies have shown a culprit coronary artery occlusion in about 30% of these patients, indicating the electrocardiogram's (ECG's) limited sensitivity. The aim of this study is to determine whether immediate coronary angiography and subsequent PCI will provide outcome benefits in OHCA patients without ST elevation.

Methods/design: We describe the design of the DIrect or Subacute Coronary angiography in Out-of-hospital cardiac arrest study (DISCO)-a pragmatic national, multicenter, randomized, clinical study. OHCA patients presenting with no ST elevation on their first recorded ECG will be randomized to a strategy of immediate coronary angiography or to standard of care with admission to intensive care and angiography after 3days at the earliest unless the patient shows signs of acute ischemia or hemodynamic instability. Primary end point is 30-day survival. An estimated 1,006 patients give 80% power (α = .05) to detect a 20% improved 30-day survival rate from 45% to 54%. Secondary outcomes include good neurologic recovery at 30days and 6months, and cognitive function and cardiac function at 6months.

Conclusion: This randomized clinical study will evaluate the effect of immediate coronary angiography after OHCA on 30-day survival in patients without ST elevation on their first recorded ECG.

Trial registration: ClinicalTrials.gov NCT02309151.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Aged
  • Coronary Angiography* / methods
  • Coronary Occlusion* / complications
  • Coronary Occlusion* / diagnosis
  • Coronary Occlusion* / mortality
  • Electrocardiography* / methods
  • Female
  • Hospitalization / statistics & numerical data
  • Humans
  • Male
  • Middle Aged
  • Multicenter Studies as Topic
  • Out-of-Hospital Cardiac Arrest* / diagnosis
  • Out-of-Hospital Cardiac Arrest* / etiology
  • Out-of-Hospital Cardiac Arrest* / therapy
  • Outcome Assessment, Health Care / methods
  • Patient Care Management / methods
  • Patient Care Management / standards
  • Pragmatic Clinical Trials as Topic
  • Survival Analysis
  • Sweden
  • Time-to-Treatment* / standards

Associated data

  • ClinicalTrials.gov/NCT02309151