Monitoring Patients With Acute Cardiac Disease Using a Wireless, Wearable, Non-invasive Monitor

NCT ID: NCT04635371

Last Updated: 2021-07-07

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

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-20

Study Completion Date

2021-06-30

Brief Summary

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A prospective observational study in patients admitted with an acute cardiac disease, in which the PPG-based device will be attached to them on admission, for frequent monitoring of their vitals during hospitalization and interventional procedures. in parallel to currently-used and approved devices. Data will be crossed with gathered clinical and laboratory data, to study the device's ability to detect acute hemodynamic and respiratory changes during hospitalization, and gathering workflow information from the nursing staff.

Detailed Description

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Conditions

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Acute Cardiac Event Acute Cardiac Failure Acute Cardiac Pulmonary Edema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Non-invasive Monitoring

Wearable, wireless, non-invasive chest-patch devices will be attached to the patients following recruitment and aigning an informed consent form, and from that moment on, vitals will be collected automatically and analyzed retrospectively.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Men and women aged 18 years and above admitted to the Cardiac ICU due to an acute cardiac event.

Exclusion Criteria

* Pregnant women, subjects under the age of 18 years.
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biobeat Technologies Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronen Rubinshtein, MD

Role: PRINCIPAL_INVESTIGATOR

The Edith Wolfson Medical Center

Locations

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The Edith Wolfson Medical Center

Holon, , Israel

Site Status

Countries

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Israel

Other Identifiers

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PPGCICUWOMC

Identifier Type: -

Identifier Source: org_study_id

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