Clinical trial NCT03261089: Multimodal Outcome CHAracterization in Comatose Cardiac Arrest Patients Registry and Tissue Repository
Official title: MOCHA Study: Multimodal Outcome CHAracterization in Comatose Cardiac Arrest Patients Data Registry and Tissue Repository
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Arrest
Keywords: coma, prognosis, cardiac arrest
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: University of Florida
name: Hospital Israelita Albert Einstein
name: Faculty of Medicine of Ribeirão Preto (FMRP-USP)
name: University of Sao Paulo General Hospital
name: Yale University
name: University of Pennsylvania
name: University of California, San Francisco
name: D'Or Institute for Research and Education
name: Americas Medical City: Hospital Samaritano and Hospital Vitória
First posted: 2017-08-24
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Unresponsive patients post-cardiac arrest

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glasgow-Pittsburgh Cerebral Performance Category Scale (CPC)
timeFrame: at 6 months post-arrest
Secondary outcomes:
measure: modified Rankin Score (mRS)
timeFrame: at 6 months post-arrest
measure: Cerebral Performance Category- Extended (CPC-E)
timeFrame: at 6 months post-arrest
measure: Brief Test of Adult Cognition by Telephone (BTACT)
timeFrame: at 6 months post-arrest
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: at 6 months post-arrest
measure: Short Form 36
timeFrame: at 6 months post-arrest
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: David Greer, MD MA
role: STUDY_CHAIR
References: