Digital therapy management for coronary heart disease risk factors
Klinische Studie Zur Untersuchung Und Validierung Eines Therapieverfahrens Zur Einstellung Von Risikofaktoren Bei Patienten Mit Koronarer Herzkrankheit (KHK) Mittels Digitaler Therapiesteuerung
iATROS GmbH · NCT06091774
This study tests if a new digital therapy management system can help people with coronary heart disease better manage their risk factors compared to regular medical care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | iATROS GmbH (industry) |
| Locations | 1 site (Munich, Bavaria) |
| Trial ID | NCT06091774 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and effectiveness of the iATROS digital therapy management system for adjusting risk factors in patients with coronary heart disease (CHD). It compares the digital approach to the standard medical care currently provided. The study will also evaluate the functionality of the rule engine within the iATROS platform and explore the use of smartphones in the secondary prevention and management of CHD. Data collected will contribute to the further development of this digital treatment tool.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with ischemic heart disease who have experienced specific cardiac events or interventions.
Not a fit: Patients who do not own or cannot use a smartphone or those with severe cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the management of coronary heart disease and improve patient outcomes through personalized digital interventions.
How similar studies have performed: While the use of digital health interventions is gaining traction, this specific approach using the iATROS platform is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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 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).
Where this trial is running
Munich, Bavaria
- Klinikum der Ludwig-Maximilians-Universität München (Klinikum der Universität München), Medizinische Klinik und Poliklinik I — Munich, Bavaria, Germany (RECRUITING)
Study contacts
- Principal investigator: Moritz Sinner, PD Dr. med — Medizinische Klinik I und Poliklinik LMU Klinikum Campus Großhadern
- Study coordinator: Paul Weyh, M. Sc.
- Email: paul.weyh@i-atros.com
- Phone: +49 176 856 23 142
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Disease, Cardiovascular Diseases, Coronary Heart Disease, Ischemic Heart Disease, eHealth, cardiology, coronary artery disease