Cardiovascular Diseases
Conditions
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.
Interventions
DEVICETelemonitoring System using Cosinuss° Two and/or Garmin Vivoactive 4
Development and validation of a telemonitoring system using smart devices
Sponsors
Medical University Innsbruck
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 other cardiovascular condition | from inclusion to end of study (max. 3 years) |
| number of patients admitted to intensive care unit | from inclusion to end of study (max. 3 years) |
| number of days with successful telemonitoring | 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
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Autonomic Function | from inclusion to end of study (max. 3 years) | Heart Rate Variability (HRV), Deceleration Capacity (DC), Periodic Repolarization Dynamics (PRD), Baroreflex Sensitivity, ... |
Countries
Austria
Outcome results
None listed