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

NCT ID: NCT03261089

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-02

Study Completion Date

2027-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiac Arrest

Keywords

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coma, prognosis, cardiac arrest

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role collaborator

Hospital Israelita Albert Einstein

OTHER

Sponsor Role collaborator

Faculty of Medicine of Ribeirão Preto (FMRP-USP)

OTHER

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

D'Or Institute for Research and Education

OTHER

Sponsor Role collaborator

Americas Medical City: Hospital Samaritano and Hospital Vitória

UNKNOWN

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Greer, MD MA

Role: STUDY_CHAIR

Boston Medical Center

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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David Greer, MD MA

Role: CONTACT

Phone: 617- 638-5127

Email: [email protected]

Cathi Thomas

Role: CONTACT

Phone: 617- 638-8456

Email: [email protected]

Facility Contacts

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David Greer, MD MA

Role: primary

Other Identifiers

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H-36257

Identifier Type: -

Identifier Source: org_study_id