Early Coronary Angiography Versus Delayed Coronary Angiography

Cardiac Arrest Clinical Trial

— PEARL  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02387398
• Other study ID #: NCT02387398
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: April 30, 2019

Study information

• Verified date: December 2021
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 99
• Est. completion date: April 30, 2019
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Hypothermia
• Out-of-Hospital Cardiac Arrest

Intervention

Procedure:
• Early Angiography
Coronary Angiography within 120 minutes of admission for out-of-hospital cardiac arrest with ROSC

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne	Victoria
Slovenia	University Medical Center Ljubljana	Ljubljana
United States	Tufts University School of Medicine, Maine Medical Center	Portland	Maine
United States	Mayo Clinic Cardiovascular Research Unit	Rochester	Minnesota
United States	Banner University Medical Center-South Campus	Tucson	Arizona
United States	Banner University Medical Center-Tucson Campus	Tucson	Arizona

Sponsors (5)

Lead Sponsor	Collaborator
University of Arizona	MaineHealth, Mayo Clinic, The Alfred, University Medical Centre Ljubljana

Countries where clinical trial is conducted

United States,  Australia,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	30 days and 180 days
Secondary	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
Secondary	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