Development and Validation of a Telemonitoring System for High-risk Cardiovascular Patients
Active, not recruiting
- Conditions
- Cardiovascular Diseases
- Registration Number
- NCT05485532
- Lead Sponsor
- Medical University Innsbruck
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1000
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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) number of days with successful telemonitoring from inclusion to end of study (max. 3 years) occurence of all cause mortality 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 with hospitalization due to decompensated heart failure 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) occurence of myocardial infarction from inclusion to end of study (max. 3 years)
Trial Locations
- Locations (2)
Medizinische Universität Innsbruck, Univ.-Klinik für Innere Medizin III, Kardiologie und Angiologie
🇦🇹Innsbruck, Tyrol, Austria
Reha Zentrum Münster
🇦🇹Münster, Tyrol, Austria