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

NCT05485532 | Active Not Recruiting

• 1 other identifier: 1282/2020
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (8)

• occurence of all cause mortality

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

• occurence of cardiovascular mortality

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

• occurence of stroke

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

• occurence of myocardial infarction

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

• number of patients with hospitalization due to decompensated heart failure

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

Other Outcomes (1)

• Cardiac Autonomic Function

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

Interventions

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

Development and validation of a telemonitoring system using smart devices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• missing informed consent
• pregnant and breast-feeding women

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (2)

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

Innsbruck, Tyrol, 6020, Austria

Location

Reha Zentrum Münster

Münster, Tyrol, 6232, Austria

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department for Internal Medicine III - Cardiology and Angiology

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: August 3, 2022
• Study Start: January 1, 2021
• Primary Completion: January 1, 2025
• Study Completion (Estimated): January 1, 2028
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)