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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

RECRUITINGSponsored by iATROS GmbH
Actively Recruiting
SponsoriATROS GmbH
Started2023-10-05
Est. completion2025-04
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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).

Conditions5

Cardiovascular DiseasesCoronary Artery DiseaseCoronary Heart DiseaseHeart DiseaseIschemic Heart Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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