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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02387398




Registration number
NCT02387398
Ethics application status
Date submitted
26/02/2015
Date registered
13/03/2015
Date last updated
18/01/2019

Titles & IDs
Public title
Early Coronary Angiography Versus Delayed Coronary Angiography
Scientific 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
Secondary ID [1] 0 0
NCT02387398
Universal Trial Number (UTN)
Trial acronym
PEARL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Out-of-Hospital Cardiac Arrest 0 0
Hypothermia 0 0
Cardiac Arrest 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Early Angiography

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

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.


Treatment: Surgery: Early Angiography
Coronary Angiography within 120 minutes of admission for out-of-hospital cardiac arrest with ROSC

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
180 days
Secondary outcome [1] 0 0
Survival from hospital at: 30 days post discharge and 180 days post discharge - 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.
Timepoint [1] 0 0
30 days and 180 days
Secondary outcome [2] 0 0
Cognitive functional status - As measured by Modified Rankin Score (mRS) and Cerebral Performance Category (CPC) at multiple points up to 180 days post hospital discharge
Timepoint [2] 0 0
180 days
Secondary outcome [3] 0 0
Neurocognitive Testing - 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
Timepoint [3] 0 0
180 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Maine
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
Slovenia
State/province [4] 0 0
Ljubljana

Funding & Sponsors
Primary sponsor type
Other
Name
University of Arizona
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Maine Medical Center
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University Medical Centre Ljubljana
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Mayo Clinic
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
The Alfred
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02387398
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Karl B Kern, MD
Address 0 0
University of Arizona
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications