Development and Validation of a Telemonitoring System for High-risk Cardiovascular Patients (TELE-CARDIO)

November 19, 2024 updated by: Univ. Prof. Dr. Axel Bauer, Medical University Innsbruck

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Medizinische Universität Innsbruck, Univ.-Klinik für Innere Medizin III, Kardiologie und Angiologie
      • Münster, Tyrol, Austria, 6232
        • Reha Zentrum Münster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with presence of inclusion criteria presenting at one of the participating centres.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
from inclusion to end of study (max. 3 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
occurence of all cause mortality
Time Frame: from inclusion to end of study (max. 3 years)
from inclusion to end of study (max. 3 years)
occurence of cardiovascular mortality
Time Frame: from inclusion to end of study (max. 3 years)
from inclusion to end of study (max. 3 years)
occurence of stroke
Time Frame: from inclusion to end of study (max. 3 years)
from inclusion to end of study (max. 3 years)
occurence of myocardial infarction
Time Frame: from inclusion to end of study (max. 3 years)
from inclusion to end of study (max. 3 years)
number of patients with hospitalization due to decompensated heart failure
Time Frame: from inclusion to end of study (max. 3 years)
from inclusion to end of study (max. 3 years)
number of patients with hospitalization due to other cardiovascular condition
Time Frame: from inclusion to end of study (max. 3 years)
from inclusion to end of study (max. 3 years)
number of patients admitted to intensive care unit
Time Frame: from inclusion to end of study (max. 3 years)
from inclusion to end of study (max. 3 years)
number of days with successful telemonitoring
Time Frame: from inclusion to end of study (max. 3 years)
from inclusion to end of study (max. 3 years)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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, ...
from inclusion to end of study (max. 3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

July 21, 2022

First Submitted That Met QC Criteria

August 2, 2022

First Posted (Actual)

August 3, 2022

Study Record Updates

Last Update Posted (Estimated)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1282/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe