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OpenTrials
Active, Not Recruiting

NCT Number: NCT05485532

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Development and validation of a telemonitoring system using smart devices

Primary outcomes

  1. occurence of combination of cardiovascular mortality, stroke, myocardial infarction and hospitalization due to decompensated heart failure

    Time frame: from inclusion to end of study (max. 3 years)

Secondary outcomes

  1. occurence of all cause mortality

    Time frame: from inclusion to end of study (max. 3 years)

  2. occurence of cardiovascular mortality

    Time frame: from inclusion to end of study (max. 3 years)

  3. occurence of stroke

    Time frame: from inclusion to end of study (max. 3 years)

  4. occurence of myocardial infarction

    Time frame: from inclusion to end of study (max. 3 years)

  5. number of patients with hospitalization due to decompensated heart failure

    Time frame: from inclusion to end of study (max. 3 years)

  6. number of patients with hospitalization due to other cardiovascular condition

    Time frame: from inclusion to end of study (max. 3 years)

  7. number of patients admitted to intensive care unit

    Time frame: from inclusion to end of study (max. 3 years)

  8. number of days with successful telemonitoring

    Time frame: from inclusion to end of study (max. 3 years)

Other outcomes

  1. Cardiac Autonomic Function

    Time frame: from inclusion to end of study (max. 3 years)

    Heart Rate Variability (HRV), Deceleration Capacity (DC), Periodic Repolarization Dynamics (PRD), Baroreflex Sensitivity, ...

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Acronym: TELE-CARDIO

Important dates

Study start
2021
Primary completion
2025
Study completion
2028
First posted
Aug 3, 2022
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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