NCT02387398: PEARL

Early Coronary Angiography Versus Delayed Coronary Angiography

Terminated NA Last updated 14 January 2022

What this trial tests

NA trial testing Early Angiography in Out-of-Hospital Cardiac Arrest in 99 participants. Terminated before completion.

Timeline

1 January 2016

Primary endpoint
31 October 2018

30 April 2019

Quick facts

Lead sponsor	University of Arizona
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	99
Start date	1 January 2016
Primary completion	31 October 2018
Estimated completion	30 April 2019
Sites	6 locations across Slovenia, United States, Australia

Drugs / interventions tested

• Early Angiography

Conditions studied

• Out-of-Hospital Cardiac Arrest — all drugs for Out-of-Hospital Cardiac Arrest →
• Hypothermia — all drugs for Hypothermia →
• Cardiac Arrest — all drugs for Cardiac Arrest →

Sponsor

University of Arizona

Who can join

18 and older, any sex, with Out-of-Hospital Cardiac Arrest or Hypothermia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Randomized Pilot Clinical Trial of Early Coronary Angiography Versus No Early Coronary Angiography After Cardiac Arrest Without ST-Segment Elevation: The PEARL Study.
   Kern KB, Radsel P, Jentzer JC, Seder DB, et al · · 2020 · cited 118× · PMID 32985249 · DOI 10.1161/circulationaha.120.049569
2. Post-resuscitation shock: recent advances in pathophysiology and treatment.
   Jozwiak M, Bougouin W, Geri G, Grimaldi D, et al · · 2020 · cited 83× · PMID 33315152 · DOI 10.1186/s13613-020-00788-z
3. Approaches to community consultation in exception from informed consent: Analysis of scope, efficiency, and cost at two centers.
   Eubank L, Lee KS, Seder DB, Strout T, et al · · 2018 · cited 14× · PMID 29964145 · DOI 10.1016/j.resuscitation.2018.06.031
4. Contemporary Management of Out-of-hospital Cardiac Arrest in the Cardiac Catheterisation Laboratory: Current Status and Future Directions.
   Pareek N, Kordis P, Webb I, Noc M, et al · · 2019 · cited 13× · PMID 31867056 · DOI 10.15420/icr.2019.3.2
5. Management of Patients With Cardiac Arrest Complicating Myocardial Infarction in New York Before and After Public Reporting Policy Changes.
   Strom JB, McCabe JM, Waldo SW, Pinto DS, et al · · 2017 · cited 9× · PMID 28495895 · DOI 10.1161/circinterventions.116.004833
6. Effect of Public Reporting on the Utilization of Coronary Angiography After Out-of-Hospital Cardiac Arrest.
   Nathan AS, Shah RM, Khatana SA, Dayoub E, et al · · 2019 · cited 7× · PMID 30998398 · DOI 10.1161/circinterventions.118.007564
7. Coronary Angiography in Patients With Out-of-Hospital Cardiac Arrest Without ST-Segment Elevation on Electrocardiograms: A Comprehensive Review.
   Kumar S, Abdelghaffar B, Iyer M, Shamaileh G, et al · · 2023 · cited 4× · PMID 39132520 · DOI 10.1016/j.jscai.2022.100536
8. Community consultation for Exception from Informed consent (EFIC) before and during the COVID-19 pandemic.
   Gagnon DJ, Riker RR, Chessa F, Lord C, et al · · 2022 · cited 4× · PMID 36281353 · DOI 10.1016/j.resplu.2022.100322