Multimodal Outcome CHAracterization in Comatose Cardiac Arrest Patients Registry and Tissue Repository

Recruiting

• Conditions: Cardiac Arrest

• Registration Number: NCT03261089
• Lead Sponsor: Boston Medical Center

Brief Summary

Cardiovascular disease remains the leading cause of death in the United States. Mortality rates of cardiac arrest range from 60-85%, and approximately 80% of survivors are initially comatose. Of those who survive, 50% are left with a permanent neurological disability, and only 10% are able to resume their former lifestyle. Early prognosis of comatose patients after cardiac arrest is critical for management of these patients, yet predicting outcome for these patients remains quite challenging.

The primary study objective of MOCHA is to develop an accurate and reliable assessment algorithm for determining neurologic prognosis in patients initially unconscious (no eye opening, GCS-M\<6 and not following commands) post-cardiac arrest, using multiple prognostic modalities at standardized time points.

Detailed Description

The investigators will conduct a prospective, international, observational study of cardiac arrest survivors using guideline-recommended prognostic assessment tools with central adjudication of results, while avoiding premature withdrawal of life-sustaining therapy (WLST). The investigators will prospectively collect data on demographics, premorbid characteristics, details of cardiac arrest and resuscitation, post-cardiac arrest care, detailed neurological examination findings, electrophysiologic studies, chemical biomarkers and neuroimaging at standardized time points, and will assess functional outcomes at discharge, 6- and 12-month follow-up, as well as annually up to 5 years. The international cohort will have a derivation subset that will be used to create a multimodal outcome prediction model (using regression analysis), which will then be confirmed by the validation subset. A substudy of MOCHA will also explore the impact of the practice of WLST in the prediction model by analyzing its performance in a pooled cohort of subjects unexposed to WLST originating from countries where this practice is not common.

Study Timeline

• Study Start: 2017-08-02
• Study First Submitted: 2017-08-21
• Study First Submitted QC: 2017-08-22
• Study First Posted: 2017-08-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-22
• Last Update Posted: 2024-12-27
• Primary Completion: 2027-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Age 18 years and older (no upper age limit)
• Initially unconscious following cardiac arrest from any non-perfusing rhythm (i.e., ventricular tachycardia, ventricular fibrillation, pulseless electrical activity, asystole)
• Sustained return of spontaneous circulation (ROSC) as defined by maintained spontaneous circulation for at least 20 minutes after cardiopulmonary resuscitation.

Exclusion Criteria

• Subjects younger than 18 years of age
• Isolated respiratory arrest without concomitant or ensuing cardiac arrest

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glasgow-Pittsburgh Cerebral Performance Category Scale (CPC)	at 6 months post-arrest	dichotomized good vs poor outcome

Secondary Outcome Measures

Name	Time	Method
Cerebral Performance Category- Extended (CPC-E)	at 6 months post-arrest	categorical
modified Rankin Score (mRS)	at 6 months post-arrest	dichotomized
Brief Test of Adult Cognition by Telephone (BTACT)	at 6 months post-arrest	categorical
Montreal Cognitive Assessment (MOCA)	at 6 months post-arrest	categorical
Short Form 36	at 6 months post-arrest	categorical

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States