Development and Validation of a Telemonitoring System for High-risk Cardiovascular Patients

NCT ID: NCT05485532

Last Updated: 2024-11-21

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

ACTIVE_NOT_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2028-01-31

Brief Summary

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Development and validation of a telemonitoring system for high-risk cardiovascular patients.

The main purpose of this study is to investigate the beneficial effect of continuous telemonitoring in patients with cardiovascular diseases in different clinical settings (hospitalized patients, ambulant patients, patients during cardiac rehabilitation,...) Beside established risk parameters such as HRV (heart rate variability) and DC (Deceleration Capacity) new risk stratification models should be established from the continuously recorded biosignals.

Detailed Description

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Conditions

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Cardiovascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Telemonitoring System using Cosinuss° Two and/or Garmin Vivoactive 4

Development and validation of a telemonitoring system using smart devices

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* decidable male and female patients \> 18 years of age
* cardiovascular disease with at least one of the following criteria:
* LVEF ≤ 40%
* cardiac autonomic dysfunction
* St. p. myocardial infarction
* St. p. cardiopulmonary resuscitation
* St. p. pulmonalartery embolism
* St. p. decompensated heart failure
* Informed consent for participation in the clinical trial

Exclusion Criteria

* missing informed consent
* pregnant and breast-feeding women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role lead

Responsible Party

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Univ. Prof. Dr. Axel Bauer

Director of Department for Internal Medicine III - Cardiology and Angiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medizinische Universität Innsbruck, Univ.-Klinik für Innere Medizin III, Kardiologie und Angiologie

Innsbruck, Tyrol, Austria

Site Status

Reha Zentrum Münster

Münster, Tyrol, Austria

Site Status

Countries

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Austria

Other Identifiers

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1282/2020

Identifier Type: -

Identifier Source: org_study_id

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