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 (ERKHA)

iATROS

Status: Enrolling

Conditions: Ischemic Heart Disease; Coronary Artery Disease; Coronary Heart Disease; Cardiovascular Diseases

Treatments: Device: CHD therapy through iATROS medical device

Study type: Observational

Funder types: Industry

Identifiers

NCT06091774

03

Details and patient eligibility

About

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).

Full 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 standard of care.

In addition, data will be provided to investigate the functionality of the rule engine in the treatment of CHD patients and insights will be gained for the further development of this component of the iATROS platform for the digital and intelligent treatment of patients.

Furthermore, the use of digital everyday products (smartphones) in secondary prevention and therapy management of CHD patients will be considered.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

1,000 participants in 2 patient groups

Group with the medical device "iATROS"

Description:

Patients are subsequently assigned to one of the two groups in a 1:1 randomization. The treatment to be carried out in the intervention group is the use of the therapy control for the treatment of CHD, which is played out via the iATROS medical device. At the start of the digital treatment, the patients receive suitable measuring devices for recording their vital parameters in the home environment. With the completion of the visit in month 9, the active phase of the study has ended. Patients will now use the iATROS medical device for another 9 months, after which the stability of the intervention effects will be determined.

Treatment:

Device: CHD therapy through iATROS medical device

Group without the medical device "iATROS"

Description:

All patients in the control group will receive standard-of-care treatment in the 9 months after randomization. There will be no further intervention during this phase. Similarly, treatment is not influenced or restricted in terms of free choice of medical care or medical treatment. Subsequently, they also receive access to the iATROS medical device. Patients will receive suitable measuring devices for recording their vital parameters in the home environment. The effects of the intervention will be recorded after 9 months.