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

Cardiac Arrest Clinical Trial

— MOCHA  

Official title:

MOCHA Study: Multimodal Outcome CHAracterization in Comatose Cardiac Arrest Patients Data Registry and Tissue Repository

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03261089
• Other study ID #: H-36257
• Status: Recruiting
• Start date: August 2, 2017
• Est. completion date: August 2027

Study information

• Verified date: January 2024
• Source: Boston Medical Center
• Contact: David Greer, MD MA
• Phone: 617- 638-5127
• Email: dgreer[@]bu.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 2027
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (10)

Lead Sponsor	Collaborator
Boston Medical Center	Americas Medical City: Hospital Samaritano and Hospital Vitória, D'Or Institute for Research and Education, Faculty of Medicine of Ribeirão Preto (FMRP-USP), Hospital Israelita Albert Einstein, University of California, San Francisco, University of Florida, University of Pennsylvania, University of Sao Paulo General Hospital, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glasgow-Pittsburgh Cerebral Performance Category Scale (CPC)	dichotomized good vs poor outcome	at 6 months post-arrest
Secondary	modified Rankin Score (mRS)	dichotomized	at 6 months post-arrest
Secondary	Cerebral Performance Category- Extended (CPC-E)	categorical	at 6 months post-arrest
Secondary	Brief Test of Adult Cognition by Telephone (BTACT)	categorical	at 6 months post-arrest
Secondary	Montreal Cognitive Assessment (MOCA)	categorical	at 6 months post-arrest
Secondary	Short Form 36	categorical	at 6 months post-arrest