MOCHA: Multimodal Outcome CHAracterization in Comatose Cardiac Arrest Patients Registry and Tissue Repository
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Unresponsive patients post-cardiac arrest As early as possible post-resuscitation, patients should undergo a detailed neurologic examination, comprised of a thorough assessment for consciousness and detailed cranial nerve function and motor response assessments. Neurologic assessment scores such as the Full Outline of Unresponsiveness, Glasgow Coma Scale (GCS), and Pittsburgh Cardiac Arrest Category Score will be also be used. On the first assessment (day of cardiac arrest), the PCAC score should be assigned only on the basis of the best neurologic exam in the first 6 hours after ROSC. Patients that are sedated or intubated will have the verbal score of GCS be estimated by a derivation of motor and eye scores. The presence of potential confounders, including core body temperature, medications, and/or intoxicants, as well as metabolic derangements should be noted. |
Outcome Measures
Primary Outcome Measures
- Glasgow-Pittsburgh Cerebral Performance Category Scale (CPC) [at 6 months post-arrest]
dichotomized good vs poor outcome
Secondary Outcome Measures
- modified Rankin Score (mRS) [at 6 months post-arrest]
dichotomized
- Cerebral Performance Category- Extended (CPC-E) [at 6 months post-arrest]
categorical
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18 years and older (no upper age limit)
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Initially unconscious following cardiac arrest from any non-perfusing rhythm (i.e., ventricular tachycardia, ventricular fibrillation, pulseless electrical activity, asystole)
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Sustained return of spontaneous circulation (ROSC) as defined by maintained spontaneous circulation for at least 20 minutes after cardiopulmonary resuscitation.
Exclusion Criteria:
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Subjects younger than 18 years of age
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Isolated respiratory arrest without concomitant or ensuing cardiac arrest
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
Sponsors and Collaborators
- Boston Medical Center
- University of Florida Health
- Hospital Israelita Albert Einstein
- Hospital das Clínicas de Ribeirão Preto
- University of Sao Paulo General Hospital
- Yale University
- University of Pennsylvania
- University of California, San Francisco
Investigators
- Study Chair: David Greer, MD MA, Boston Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-36257