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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Device: Telemonitoring System using Cosinuss° Two and/or Garmin Vivoactive 4


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 decompensated heart failure |  | 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) |