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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Boston Medical Center
RECRUITING
Boston
Contact Information
Primary
David Greer, MD MA
dgreer@bu.edu
617- 638-5127
Backup
Cathi Thomas
neurocat@bu.edu
617- 638-8456
Time Frame
Start Date: 2017-08-02
Estimated Completion Date: 2027-08
Participants
Target number of participants: 600
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Sao Paulo General Hospital, Yale University, University of Florida, Americas Medical City: Hospital Samaritano and Hospital Vitória, D'Or Institute for Research and Education, Faculty of Medicine of Ribeirão Preto (FMRP-USP), University of California, San Francisco, Hospital Israelita Albert Einstein, University of Pennsylvania
Leads: Boston Medical Center

This content was sourced from clinicaltrials.gov