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Early Coronary Angiography Versus Delayed Coronary Angiography (PEARL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02387398
Recruitment Status : Active, not recruiting
First Posted : March 13, 2015
Last Update Posted : January 18, 2019
Sponsor:
Collaborators:
Maine Medical Center
University Medical Centre Ljubljana
Mayo Clinic
The Alfred
Information provided by (Responsible Party):
Karl Kern, University of Arizona

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.

Condition or disease Intervention/treatment Phase
Out-of-Hospital Cardiac Arrest Hypothermia Cardiac Arrest Procedure: Early Angiography Not Applicable

Detailed Description:

Cardiac arrest is a major public health issue. Arizona has been a leader in improving long-term survival by introducing new and innovative resuscitation approaches including "Chest Compression-Only CPR" and "Cardiocerebral Resuscitation". Post-resuscitation care is the next great opportunity for further improvements. Early coronary angiography (CAG) combined with therapeutic hypothermia has become the recommended standard of care for post-cardiac arrest patients manifesting ST segment elevation on their electrocardiogram (ECG). However, the majority of cardiac arrest victims do not have ST segment elevation. There is clinical equipoise as to whether these patients will benefit from early CAG.

Subjects who are qualified for the study will be randomized 1:1 to one of two groups.

° Intervention Group-Early coronary angiography (door-to-angiography) within 120 minutes of admission to Emergency Department.

or

° Control Group-No early coronary angiography (within the first six hours from admission)

All enrolled patients, will be treated with therapeutic hypothermia which is standard of care, beginning simultaneously with both groups or within at least 2 hours of hospital arrival.

Subject will be followed for 180 days for safety and long-term survival.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Randomized Clinical Trial of Early Coronary Angiography Versus No Early Coronary Angiography for Post-Cardiac Arrest Patients Without ECG ST Segment Elevation
Study Start Date : December 2015
Actual Primary Completion Date : October 31, 2018
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interventional
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
Coronary Angiography within 120 minutes of admission for out-of-hospital cardiac arrest with ROSC

No Intervention: Control Group
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.



Primary Outcome Measures :
  1. Safety and Efficacy of early coronary angiography in the out-of-hospital cardiac arrest (OHCA) patient population. [ Time Frame: 180 days ]
    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.


Secondary Outcome Measures :
  1. Survival from hospital at: 30 days post discharge and 180 days post discharge [ Time Frame: 30 days and 180 days ]
    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, survival to discharge and favourable. Left ventricular regional function and left ventricular ejection fraction as measured by echocardiography will be measured prior to discharge or up to 180 days post hospital discharge.

  2. Cognitive functional status [ Time Frame: 180 days ]
    As measured by Modified Rankin Score (mRS) and Cerebral Performance Category (CPC) at multiple points up to 180 days post hospital discharge

  3. Neurocognitive Testing [ Time Frame: 180 days ]
    Neurocognitive function will be assessed at various time points utilizing a variety of tests from ICU discharge to 180 days post hospital discharge such as MMSE, MOCA, HADS, and IQCODE



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Non-resuscitated (no sustained pulse and BP)
  2. Presence ST segment elevation or new left bundle branch block present on the post-resuscitation ECG
  3. 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
  4. Known "Do Not Resuscitate" status
  5. Minors (<18 years old)
  6. Prisoners
  7. Significant bleeding or blunt trauma
  8. Known or confirmed pregnancy test by urinalysis
  9. 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.
  10. Known "opt out" choice; wearing Opt-out band for any EFIC approved study or on an "Opt-out" list

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387398


Locations
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United States, Arizona
Banner University Medical Center-South Campus
Tucson, Arizona, United States, 85724
Banner University Medical Center-Tucson Campus
Tucson, Arizona, United States, 85724
United States, Maine
Tufts University School of Medicine, Maine Medical Center
Portland, Maine, United States, 04103
United States, Minnesota
Mayo Clinic Cardiovascular Research Unit
Rochester, Minnesota, United States, 55905
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Slovenia
University Medical Center Ljubljana
Ljubljana, Slovenia
Sponsors and Collaborators
University of Arizona
Maine Medical Center
University Medical Centre Ljubljana
Mayo Clinic
The Alfred
Investigators
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Principal Investigator: Karl B Kern, MD University of Arizona

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Responsible Party: Karl Kern, MD, University of Arizona
ClinicalTrials.gov Identifier: NCT02387398    
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Hypothermia
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms