Early Coronary Angiography Versus Delayed Coronary Angiography

Stopped early · Not applicable

Conditions studied: Out-of-Hospital Cardiac Arrest, Hypothermia, Cardiac Arrest

In brief

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.

Key facts

Study ID

NCT02387398

Run by

University of Arizona

People needed

99

Starts

2016-01-01

Expected to finish

2019-04-30

Last updated by the study team

2022-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All successfully resuscitated out-of-hospital cardiac arrest patients with a suspected cardiac etiology for their non-traumatic arrest
• Age greater than 18 years
• The post resuscitation ECG shows no evidence of ST segment elevation

You may not qualify if…

• Non-resuscitated (no sustained pulse and BP)
• Presence ST segment elevation or new left bundle branch block present on the post-resuscitation ECG
• Suspected non-cardiac etiology for their arrest such as respiratory failure, asphyxia, pulmonary embolus, shock, trauma, drug overdose, or CNS bleed as likely cause of the cardiac arrest
• Known "Do Not Resuscitate" status
• Minors (<18 years old)
• Prisoners
• Significant bleeding or blunt trauma
• Known or confirmed pregnancy test by urinalysis
• Patients who are known to have received any other investigational therapies within the 30 days prior to enrollment or during study duration will be excluded unless these studies have been reviewed and approved by the Study Steering Committee.
• Known "opt out" choice; wearing Opt-out band for any EFIC approved study or on an "Opt-out" list

Where it is running

• Banner University Medical Center-South Campus — Tucson, Arizona, United States
• Banner University Medical Center-Tucson Campus — Tucson, Arizona, United States
• Tufts University School of Medicine, Maine Medical Center — Portland, Maine, United States
• Mayo Clinic Cardiovascular Research Unit — Rochester, Minnesota, United States
• Alfred Hospital — Melbourne, Victoria, Australia
• University Medical Center Ljubljana — Ljubljana, Slovenia

Full record on ClinicalTrials.gov

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