Out-of-Hospital Cardiac ArrestPEARLNCT02387398
Early Coronary Angiography Versus Delayed Coronary Angiography
A study testing Early Angiography in people with Out-of-Hospital Cardiac Arrest and Hypothermia, run by University of Arizona at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-of-Hospital Cardiac Arrest, Hypothermia, Cardiac Arrest
- What is being tested?
- Early Angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 1 Jan 2016to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
Tufts University School of Medicine, Maine Medical Center
Portland, Maine, 04103
Mayo Clinic Cardiovascular Research Unit
Rochester, Minnesota, 55905
Banner University Medical Center-South Campus
Tucson, Arizona, 85724
Banner University Medical Center-Tucson Campus
Tucson, Arizona, 85724
About this study
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
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.
Read the 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.
- Conditions
- Out-of-Hospital Cardiac Arrest, Hypothermia, Cardiac Arrest
- Being tested
- Early Angiography
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Hypothermia, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early AngiographyProcedure or surgery
Coronary Angiography within 120 minutes of admission for out-of-hospital cardiac arrest with ROSC
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180 days
Secondary outcomes (3)
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.
Measured: 30 days and 180 days
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
Measured: 180 days
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
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study start1 Jan 2016
- Primary completion31 Oct 2018
- Study completion30 Apr 2019
Why it stopped: Funded study period, including a one-year no cost extension, completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Out-of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- MaineHealth, University Medical Centre Ljubljana, Mayo Clinic, The Alfred
- Responsible party
- Principal investigator, Karl Kern, University of Arizona
- Investigators
- Karl B Kern, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387398
- Sponsor's protocol ID
- NCT02387398
- Acronym
- PEARL
- Status last verified
- Dec 2021
- First submitted
- 26 Feb 2015
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 32985249
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02387398
- Acronym / sponsor ID
- PEARL / NCT02387398
- Conditions
- Out-of-Hospital Cardiac Arrest, Hypothermia, Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funded study period, including a one-year no cost extension, completed.
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- MaineHealth, University Medical Centre Ljubljana, Mayo Clinic, The Alfred
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 13 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Procedure: Early AngiographyEarly 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early AngiographyCoronary Angiography within 120 minutes of admission for out-of-hospital cardiac arrest with ROSC | Procedure or surgery | Interventional |
Primary outcome
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.
3 secondary outcomes
Survival from hospital at: 30 days post discharge and 180 days post discharge
Time frame: 30 days and 180 days
Cognitive functional status
Time frame: 180 days
Neurocognitive Testing
Time frame: 180 days
Results and safety
The study was stopped early (reason given: Funded study period, including a one-year no cost extension, completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Derived from this study: PubMed 32985249Kern 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl B Kern, MD principal investigator
University of Arizona
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Angiography in people with Out-of-Hospital Cardiac Arrest and Hypothermia, run by University of Arizona at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Australia, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funded study period, including a one-year no cost extension, completed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Efficacy of early coronary angiography in the out-of-hospital cardiac arrest (OHCA) patient population. (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02387398, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.