An interventional study of Early Angiography in Out-of-Hospital Cardiac Arrest, Hypothermia and Cardiac Arrest, sponsored by University of Arizona. Terminated at 6 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-14.
Sponsored by University of Arizona · Not applicable, Interventional, and Treatment
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.
966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's enrollment of 99 is close to the median of 100 across 557 interventional studies indexed under Heart Arrest.
Browse Heart Arrest studies →University of Arizona is the lead sponsor of 466 studies on the registry; 87 are open to participants now.
Of its 47 completed or terminated interventional studies of FDA-regulated products, 29 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Coronary Angiography within 120 minutes of admission for out-of-hospital cardiac arrest with ROSC
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.
Time frame: 180 days
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.
Time frame: 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
Time frame: 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
Time frame: 180 days
Plan to share: Yes
This study is terminated, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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