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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03261089
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : August 11, 2021
University of Florida Health
Hospital Israelita Albert Einstein
Hospital das Clínicas de Ribeirão Preto
University of Sao Paulo General Hospital
Information provided by (Responsible Party):
Boston Medical Center

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
Cardiac Arrest

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: MOCHA Study: Multimodal Outcome CHAracterization in Comatose Cardiac Arrest Patients Data Registry and Tissue Repository
Actual Study Start Date : August 2, 2017
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest Coma

Primary Outcome Measures :
  1. Glasgow-Pittsburgh Cerebral Performance Category Scale (CPC) [ Time Frame: at 6 months post-arrest ]
    dichotomized good vs poor outcome

Secondary Outcome Measures :
  1. modified Rankin Score (mRS) [ Time Frame: at 6 months post-arrest ]

  2. Cerebral Performance Category- Extended (CPC-E) [ Time Frame: at 6 months post-arrest ]

  3. Brief Test of Adult Cognition by Telephone (BTACT) [ Time Frame: at 6 months post-arrest ]

  4. Montreal Cognitive Assessment (MOCA) [ Time Frame: at 6 months post-arrest ]

  5. Short Form 36 [ Time Frame: at 6 months post-arrest ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Unresponsive patients post-cardiac arrest

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03261089

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Contact: David Greer, MD 617- 638-7730
Contact: Sherida Padilla, MD 617-638-8647

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United States, Florida
University of Florida Health Not yet recruiting
Gainesville, Florida, United States, 32611
Contact: Carolina B Maciel, MD    352-273-5550   
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: David Greer, MD    617-638-5102   
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
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Study Chair: David Greer, MD Boston Medical Center
Additional Information:

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Responsible Party: Boston Medical Center Identifier: NCT03261089    
Other Study ID Numbers: H-36257
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: August 11, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Medical Center:
coma, prognosis, cardiac arrest
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases