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

Medical University Innsbruck

Status: Active, not recruiting

Conditions: Cardiovascular Diseases

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

Study type: Observational

Funder types: Other

Identifiers

NCT05485532

1282/2020

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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