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Early Coronary Angiography Versus Delayed Coronary Angiography

NCT02387398 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2022-01-14

No results posted yet for this study

Summary

This study is a pilot, multi-centered, randomized, clinical trial to evaluate the safety and efficacy of performing early Coronary Angiography (CAG) versus no early CAG in post-cardiac arrest patients without ST segment elevation. Safety will be assessed by evaluating the association of major adverse events (re-arrest, bleeding, pulmonary edema, hypotension, acute renal insufficiency, and pneumonia) with early coronary angiogram. Efficacy will be assessed by a composite endpoint of improved left ventricular regional and global function (both regional wall motion analysis and left ventricular ejection fraction) as measured by echocardiography prior to hospital discharge and favourable neurological function (Cerebral Performance Categories 1 or 2) at discharge.

Conditions

  • Out-of-Hospital Cardiac Arrest
  • Hypothermia
  • Cardiac Arrest

Interventions

PROCEDURE

Early Angiography

Coronary Angiography within 120 minutes of admission for out-of-hospital cardiac arrest with ROSC

Sponsors & Collaborators

  • MaineHealth

    collaborator OTHER

  • University Medical Centre Ljubljana

    collaborator OTHER

  • Mayo Clinic

    collaborator OTHER

  • The Alfred

    collaborator OTHER

  • University of Arizona

    lead OTHER

Principal Investigators

  • Karl B Kern, MD · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2018-10-31
Completion
2019-04-30

Countries

  • United States
  • Australia
  • Slovenia

Study Locations

More Related Trials

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 NCT02387398 on ClinicalTrials.gov