Clinical trial NCT02387398: Early Coronary Angiography Versus Delayed Coronary Angiography
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Out-of-Hospital Cardiac Arrest
Hypothermia
Cardiac Arrest
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: MaineHealth
name: University Medical Centre Ljubljana
name: Mayo Clinic
name: The Alfred
First posted: 2015-03-13
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and Efficacy of early coronary angiography in the out-of-hospital cardiac arrest (OHCA) patient population.
timeFrame: 180 days
Secondary outcomes:
measure: Survival from hospital at: 30 days post discharge and 180 days post discharge
timeFrame: 30 days and 180 days
measure: Cognitive functional status
timeFrame: 180 days
measure: Neurocognitive Testing
timeFrame: 180 days
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University Medical Center-South Campus
state: Arizona
city: Tucson
country: United States
facility: Banner University Medical Center-Tucson Campus
state: Arizona
city: Portland
country: United States
facility: Tufts University School of Medicine, Maine Medical Center
state: Maine
city: Rochester
country: United States
facility: Mayo Clinic Cardiovascular Research Unit
state: Minnesota
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana
Study officials:
affiliation: University of Arizona
name: Karl B Kern, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.