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

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ClinicalTrials.gov Identifier: NCT03261089
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : August 24, 2017
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):
David Greer, 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.

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 1, 2022
Estimated Study Completion Date : August 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest Coma
U.S. FDA Resources

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, Senior)
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 ClinicalTrials.gov identifier (NCT number): NCT03261089

Contact: David Greer, MD 617- 638-7730 dgreer@bu.edu
Contact: Melissa Mercado, MD 617-638-8647 melissamercado@bmc.org

United States, Florida
University of Florida Health Not yet recruiting
Gainesville, Florida, United States, 32611
Contact: Carolina B Maciel, MD    352-273-5550    carolina.maciel@neurology.ufl.edu   
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: David Greer, MD    617-638-5102    dgreer@bu.edu   
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
Study Chair: David Greer, MD Boston Medical Center

Responsible Party: David Greer, Professor, Chair and Chief of Neurology, Boston Medical Center
ClinicalTrials.gov Identifier: NCT03261089     History of Changes
Other Study ID Numbers: H36257
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Greer, Boston Medical Center:
coma, prognosis, cardiac arrest

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases