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Funded study period, including a one-year no cost extension, completed.
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| Name | Class |
|---|---|
| MaineHealth | OTHER |
| University Medical Centre Ljubljana | OTHER |
| Mayo Clinic | OTHER |
| The Alfred |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Angiography | Procedure | Coronary Angiography within 120 minutes of admission for out-of-hospital cardiac arrest with ROSC |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karl B Kern, MD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center-South Campus | Tucson | Arizona | 85724 | United States | ||
| Banner University Medical Center-Tucson Campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32985249 | Derived | 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. |
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| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| D007035 | Hypothermia |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
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| OTHER |
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| 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 | 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 | 180 days |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Tufts University School of Medicine, Maine Medical Center | Portland | Maine | 04103 | United States |
| Mayo Clinic Cardiovascular Research Unit | Rochester | Minnesota | 55905 | United States |
| Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| University Medical Center Ljubljana | Ljubljana | Slovenia |
| D013568 |
| Pathological Conditions, Signs and Symptoms |