Clinical trial 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
Official title: Klinische Studie Zur Untersuchung Und Validierung Eines Therapieverfahrens Zur Einstellung Von Risikofaktoren Bei Patienten Mit Koronarer Herzkrankheit (KHK) Mittels Digitaler Therapiesteuerung
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Cardiovascular Diseases
Coronary Heart Disease
Ischemic Heart Disease
Keywords: eHealth
cardiology
coronary artery disease
Lead sponsor: iATROS GmbH
Sponsor class: INDUSTRY
First posted: 2023-10-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult (≥ 18 years) patients with a diagnosis of coronary artery disease at study inclusion AND one of the following conditions: Diagnosis of STEMI/NSTEMI , OR they have had coronary intervention (eg, stent, angioplasty, or bypass surgery) or a similar formulation, are eligible to participate in the study as long as they meet the inclusion/exclusion criteria and are insured by the cooperating insurers.

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 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.

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 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).

Primary outcomes:
measure: Proportion of patients in target range of LDL or blood pressure
timeFrame: 9 months
Secondary outcomes:
measure: Absolute LDL reduction after 9 months in patients with known LDL levels at inclusion (not older than 12 months at study inclusion) and no medication adjustment within the last 12 months prior to study inclusion.
timeFrame: 9 months
measure: Assessment of stability: Comparison of LDL levels after 18 months in patients with known LDL levels
timeFrame: 18 months
measure: Assessment of stability: Comparison of blood pressure after 18 months
timeFrame: 18 months
measure: In patients with diabetes: target blood HbA1c level of ≤ 7% or ≤ 53mmol/mol after 9 months.
timeFrame: 9 months
measure: Assessment of stability in patients with diabetes: Comparison of blood HbA1c levels after 18 months.
timeFrame: 18 months
measure: In patients with diabetes: absolute reduction in blood HbA1c level after 9 months.
timeFrame: 9 months
measure: In patients with obesity: absolute BMI reduction after 9 months.
timeFrame: 9 months
measure: Assessment of stability in patients with obesity: Comparison of BMI changes after 18 months.
timeFrame: 18 months
measure: Absolute BMI reduction in patients with initial BMI > 30kg/m2 after 9 months.
timeFrame: 9 months
measure: In patients with obesity: percentage reduction in body mass index (BMI) after 9 months, which should fall within the target range below 25 kg/m2 as best as possible according to guideline recommendations.
timeFrame: 9 months
measure: For patients with current nicotine abuse: determination of/review of smoking cessation after 9 months.
timeFrame: 9 months
measure: Assessment of stability for patients with current nicotine abuse: determination of/review of smoking cessation after 18 months.
timeFrame: 18 months
measure: Improving health literacy
timeFrame: 9 months and 18 months
measure: Assessment of stability: Improving health literacy
timeFrame: 18 months
measure: Improving patient sovereignty
timeFrame: 9 months and 18 months
measure: Assessment of stability: Improving patient sovereignty
timeFrame: 18 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum der Ludwig-Maximilians-Universität München (Klinikum der Universität München), Medizinische Klinik und Poliklinik I
state: Bayern
Study officials:
affiliation: Medizinische Klinik I und Poliklinik LMU Klinikum Campus Großhadern
name: Moritz Sinner, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
affiliation: Medizinische Klinik I und Poliklinik LMU Klinikum Campus Großhadern
name: Stefan Kääb, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: