Early Coronary Angiography Versus Delayed Coronary Angiography

NCT02387398 | Terminated DMC

• 1 other identifier: NCT02387398
• Study Type: interventional
• Target: 99
• Locations: 3 countries
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (1)

• Safety and Efficacy of early coronary angiography in the out-of-hospital cardiac arrest (OHCA) patient population.

  Safety will be assessed by evaluating any association of major adverse events (re-arrest, bleeding, pulmonary edema, hypotension, acute renal insufficiency, and pneumonia) with early coronary angiography.

  180 days

Secondary Outcomes (3)

• Survival from hospital at: 30 days post discharge and 180 days post discharge

  30 days and 180 days

• Cognitive functional status

  180 days

• Neurocognitive Testing

  180 days

Study Arms (2)

Interventional

EXPERIMENTAL

Early Angiography with purpose of coronary revascularization within 120 minutes of admission to ED, post out-of-hospital cardiac arrest, suspicious for cardiac etiology and no ST segment elevation on ECG

Procedure: Early Angiography

Control Group

NO INTERVENTION

Standard of care treatment including therapeutic hypothermia in subjects post resuscitation, out-of-hospital cardiac arrest, suspicious for cardiac etiology and no ST segment elevation on ECG.

Interventions

Early Angiography PROCEDURE

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

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Arizona: lead
• MaineHealth: collaborator
• University Medical Centre Ljubljana: collaborator
• Mayo Clinic: collaborator
• The Alfred: collaborator

Study Sites (6)

Banner University Medical Center-South Campus

Tucson, Arizona, 85724, United States

Location

Banner University Medical Center-Tucson Campus

Tucson, Arizona, 85724, United States

Location

Tufts University School of Medicine, Maine Medical Center

Portland, Maine, 04103, United States

Location

Mayo Clinic Cardiovascular Research Unit

Rochester, Minnesota, 55905, United States

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

University Medical Center Ljubljana

Ljubljana, Slovenia

Location

Related Publications (1)

• Kern KB, Radsel P, Jentzer JC, Seder DB, Lee KS, Lotun K, Janardhanan R, Stub D, Hsu CH, Noc M. Randomized Pilot Clinical Trial of Early Coronary Angiography Versus No Early Coronary Angiography After Cardiac Arrest Without ST-Segment Elevation: The PEARL Study. Circulation. 2020 Nov 24;142(21):2002-2012. doi: 10.1161/CIRCULATIONAHA.120.049569. Epub 2020 Sep 28.

  PMID: 32985249 DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Hypothermia; Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karl B Kern, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 13, 2015
• Study Start: January 1, 2016
• Primary Completion: October 31, 2018
• Study Completion: April 30, 2019
• Last Updated: January 14, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share

Locations

AU (1); SL (1); US (4)