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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

Tracking Information
First Submitted Date  ICMJE February 26, 2015
First Posted Date  ICMJE March 13, 2015
Last Update Posted Date January 18, 2019
Study Start Date  ICMJE December 2015
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 12, 2015)
Safety of early angiography (association of major adverse events (re-arrest, bleeding, pulmonary edema, hypotension, acute renal insufficiency, and pneumonia) with early coronary angiography) [ Time Frame: 30 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 at 30 days.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2015)
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2015)
  • Left ventricular function at discharge [ Time Frame: 30 days ]
    Left ventricular regional function and left ventricular ejection fraction as measured by echocardiography will be measured prior to discharge or up to 30 days post out-of-hospital cardiac arrest
  • Survival [ Time Frame: 30 days ]
    Survival status at 30 days
  • Functional Status (Modified Rankin Score) [ Time Frame: 30 days ]
    Functional status will be measured using the Modified Rankin Score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Coronary Angiography Versus Delayed Coronary Angiography
Official Title  ICMJE A Pilot Randomized Clinical Trial of Early Coronary Angiography Versus No Early Coronary Angiography for Post-Cardiac Arrest Patients Without ECG ST Segment Elevation
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Out-of-Hospital Cardiac Arrest
  • Hypothermia
  • Cardiac Arrest
Intervention  ICMJE Procedure: Early Angiography
Coronary Angiography within 120 minutes of admission for out-of-hospital cardiac arrest with ROSC
Study Arms  ICMJE
  • 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
    Intervention: Procedure: Early Angiography
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 16, 2019)
99
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2015)
240
Estimated Study Completion Date  ICMJE April 30, 2019
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Slovenia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02387398
Other Study ID Numbers  ICMJE Not Provided
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Karl Kern, University of Arizona
Study Sponsor  ICMJE University of Arizona
Collaborators  ICMJE
  • Maine Medical Center
  • University Medical Centre Ljubljana
  • Mayo Clinic
  • The Alfred
Investigators  ICMJE
Principal Investigator: Karl B Kern, MD University of Arizona
PRS Account University of Arizona
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP