Clinical trial NCT05485532: Development and Validation of a Telemonitoring System for High-risk Cardiovascular Patients
Official title: Development and Validation of a Telemonitoring System for High-risk Cardiovascular Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiovascular Diseases
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with presence of inclusion criteria presenting at one of the participating centres.

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.


Eligibility criteria: 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

Primary outcomes:
measure: occurence of combination of cardiovascular mortality, stroke, myocardial infarction and hospitalization due to decompensated heart failure
timeFrame: from inclusion to end of study (max. 3 years)
Secondary outcomes:
measure: occurence of all cause mortality
timeFrame: from inclusion to end of study (max. 3 years)
measure: occurence of cardiovascular mortality
timeFrame: from inclusion to end of study (max. 3 years)
measure: occurence of stroke
timeFrame: from inclusion to end of study (max. 3 years)
measure: occurence of myocardial infarction
timeFrame: from inclusion to end of study (max. 3 years)
measure: number of patients with hospitalization due to decompensated heart failure
timeFrame: from inclusion to end of study (max. 3 years)
measure: number of patients with hospitalization due to other cardiovascular condition
timeFrame: from inclusion to end of study (max. 3 years)
measure: number of patients admitted to intensive care unit
timeFrame: from inclusion to end of study (max. 3 years)
measure: number of days with successful telemonitoring
timeFrame: from inclusion to end of study (max. 3 years)
Other outcomes:
measure: Cardiac Autonomic Function
timeFrame: from inclusion to end of study (max. 3 years)
Locations:
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck, Univ.-Klinik für Innere Medizin III, Kardiologie und Angiologie
state: Tyrol
city: Münster
country: Austria
facility: Reha Zentrum Münster
state: Tyrol
Study officials:
References: