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

Cardiovascular Diseases Clinical Trial

— TELE-CARDIO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05485532
• Other study ID #: 1282/2020
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: January 2028

Study information

• Verified date: October 2023
• Source: Medical University Innsbruck
• Contact: Axel Bauer, Univ.Prof. Dr.
• Phone: +43 512 504 25621
• Email: axel.bauer[@]i-med.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2028
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
Austria	Medizinische Universität Innsbruck, Univ.-Klinik für Innere Medizin III, Kardiologie und Angiologie	Innsbruck	Tyrol
Austria	Reha Zentrum Münster	Münster	Tyrol

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiac Autonomic Function	Heart Rate Variability (HRV), Deceleration Capacity (DC), Periodic Repolarization Dynamics (PRD), Baroreflex Sensitivity, ...	from inclusion to end of study (max. 3 years)
Primary	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	occurence of all cause mortality		from inclusion to end of study (max. 3 years)
Secondary	occurence of cardiovascular mortality		from inclusion to end of study (max. 3 years)
Secondary	occurence of stroke		from inclusion to end of study (max. 3 years)
Secondary	occurence of myocardial infarction		from inclusion to end of study (max. 3 years)
Secondary	number of patients with hospitalization due to decompensated heart failure		from inclusion to end of study (max. 3 years)
Secondary	number of patients with hospitalization due to other cardiovascular condition		from inclusion to end of study (max. 3 years)
Secondary	number of patients admitted to intensive care unit		from inclusion to end of study (max. 3 years)
Secondary	number of days with successful telemonitoring		from inclusion to end of study (max. 3 years)