Status:
RECRUITING
Clinical Study for the Investigation and Validation of a Therapy Procedure for the Adjustment of Risk Factors in Patients With Coronary Heart Disease by Means of Digital Therapy Control
Lead Sponsor:
iATROS GmbH
Conditions:
Coronary Artery Disease
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Brief Summary
This study will test a controlled investigation of the efficacy and effectiveness of iATROS digital therapy management for risk factor adjustment in patients with coronary heart disease (CHD).
Detailed Description
The purpose of this study is to determine the efficacy and effectiveness of iATROS digital therapy management for risk factor adjustment in patients with coronary heart disease compared to the medical...
Eligibility Criteria
Inclusion
- ≥ 18 years
- Patients diagnosed with ischemic heart disease according to ICD I20 to I25 who also have at least one of the following:
- inpatient stay with acute STEMI/NSTEMI or historic STEMI/NSTEMI; and/or
- Coronary stent implantation, angioplasty or bypass surgery that has taken place.
- Ownership and use of a smartphone that allows installation and use of "iATROS," where "use" requires having the physical and mental ability to use and apply the iATROS app.
- Insured with the cooperating insurances
Exclusion
- No use of a smartphone
- Lack of the linguistic, physical and mental abilities necessary to use the iATROS app, or to use so-called "apps" on a smartphone or tablet in general.
- Absolute contraindications: Any disease associated with a reduced life expectancy of less than 2 years; Any disease/condition that limits participation in the program; Pregnant or breast feeding patients; Patients with advanced dementia
- Existing participation and enrollment in an iATROS health program.
- Participation in another clinical trial if participation results in complications with compliance, measures to be performed, bias of results, or status of treatment according to the current standard of care.
- Comorbidities or the presence of another physical condition that complicates the setting of the clinical target parameters sought in the study (i.e., if, due to the patient's individual situation, a different value would have to be issued as the target value for a clinical parameter to be classified as healthy).
Key Trial Info
Start Date :
October 5 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06091774
Start Date
October 5 2023
End Date
October 1 2026
Last Update
March 6 2024
Active Locations (1)
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1
Klinikum der Ludwig-Maximilians-Universität München (Klinikum der Universität München), Medizinische Klinik und Poliklinik I
Munich, Bavaria, Germany, 81377