Multimodal Outcome CHAracterization in Comatose Cardiac Arrest Patients Registry and Tissue Repository
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/10/2018 |
| Start Date: | August 2, 2017 |
| End Date: | August 2027 |
| Contact: | David Greer, MD |
| Email: | dgreer@bu.edu |
| Phone: | 617- 638-7730 |
MOCHA Study: Multimodal Outcome CHAracterization in Comatose Cardiac Arrest Patients Data Registry and Tissue Repository
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.
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.
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.
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.
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
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