Early Coronary Angiography Versus Delayed Coronary Angiography

Not Applicable

Terminated

• Conditions: Hypothermia; Cardiac Arrest; Out-of-Hospital Cardiac Arrest
• Interventions: Procedure: Early Angiography

• Registration Number: NCT02387398
• Lead Sponsor: University of Arizona

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.

Study Timeline

• Study First Submitted: 2015-02-26
• Study First Submitted QC: 2015-03-12
• Study First Posted: 2015-03-13
• Study Start: 2016-01-01
• Primary Completion: 2018-10-31
• Study Completion: 2019-04-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-29
• Last Update Posted: 2022-01-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional	Early Angiography	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Banner University Medical Center-Tucson Campus; 🇺🇸 Tucson, Arizona, United States

Banner University Medical Center-South Campus; 🇺🇸 Tucson, Arizona, United States

Tufts University School of Medicine, Maine Medical Center; 🇺🇸 Portland, Maine, United States

University Medical Center Ljubljana; 🇸🇮 Ljubljana, Slovenia

Mayo Clinic Cardiovascular Research Unit; 🇺🇸 Rochester, Minnesota, United States

Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia