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 :
Terminated
(Funded study period, including a one-year no cost extension, completed.)
First Posted : March 13, 2015
Last Update Posted : January 14, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Out-of-Hospital Cardiac Arrest Hypothermia Cardiac Arrest | Procedure: Early Angiography | Not Applicable |
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 : | 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 |
| Actual Study Start Date : | January 1, 2016 |
| Actual Primary Completion Date : | October 31, 2018 |
| Actual Study Completion Date : | April 30, 2019 |
| 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.
|
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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
| 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 | |
| Principal Investigator: | Karl B Kern, MD | University of Arizona |
| Responsible Party: | Karl Kern, MD, University of Arizona |
| ClinicalTrials.gov Identifier: | NCT02387398 |
| First Posted: | March 13, 2015 Key Record Dates |
| Last Update Posted: | January 14, 2022 |
| Last Verified: | December 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
|
Heart Arrest Out-of-Hospital Cardiac Arrest Hypothermia |
Heart Diseases Cardiovascular Diseases Body Temperature Changes |