NCT06091774 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
| NCT ID | NCT06091774 |
| Status | Recruiting |
| Phase | — |
| Sponsor | iATROS GmbH |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-10-05 |
| Primary Completion | 2025-04 |
Trial Parameters
Eligibility Fast-Check
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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).
Eligibility Criteria
Inclusion Criteria: * ≥ 18 years * Patients diagnosed with ischemic heart disease according to ICD I20 to I25 who also have at least one of the following: 1. inpatient stay with acute STEMI/NSTEMI or historic STEMI/NSTEMI; and/or 2. 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 Criteria: * 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 en