Cardiac Arrest, Hypothermia, Out-of-Hospital Cardiac Arrest
Conditions
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.
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.
Interventions
PROCEDUREEarly Angiography
Coronary Angiography within 120 minutes of admission for out-of-hospital cardiac arrest with ROSC
Sponsors
MaineHealth
University Medical Centre Ljubljana
Mayo Clinic
The Alfred
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Efficacy of early coronary angiography in the out-of-hospital cardiac arrest (OHCA) patient population. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival from hospital at: 30 days post discharge and 180 days post discharge | 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 | 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 | 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 |
Countries
Australia, Slovenia, United States
Outcome results
None listed