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

NCT05485532 · tracked via the Priya Life Science Austria tracker

Sponsor

Medical University Innsbruck

Phase

Observational

Started

2021-01-01

Last updated

2024-11-21

Condition(s) studied

Cardiovascular Diseases

Investigational drug(s) / intervention(s)

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

Telemonitoring System using Cosinuss° Two and/or Garmin Vivoactive 4: Development and validation of a telemonitoring system using smart devices

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

occurence of combination of cardiovascular mortality, stroke, myocardial infarction and hospitalization due to decompensated heart failure — from inclusion to end of study (max. 3 years)

Trial sites (2)

Facility	City	Region	Status
Medizinische Universität Innsbruck, Univ.-Klinik für Innere Medizin III, Kardiologie und Angiologie	Innsbruck	Tyrol
Reha Zentrum Münster	Münster	Tyrol

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05485532 on ClinicalTrials.gov ↗ ← All trials in Austria