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

NCT06091774 | Recruiting

• 1 other identifier: 03
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

eHealth; cardiology; coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Proportion of patients in target range of LDL or blood pressure

  Proportion of patients per study arm in percent with adjusted LDL cholesterol in the blood of \< 55 mg/dl (\< 1.4 mmol/l) and/or adjusted blood pressure according to ESC guideline (≤130 mmHg systolic or ≤140 mmHg systolic for age \> 70 years).

  9 months

Secondary Outcomes (16)

• 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.

  9 months

• Assessment of stability: Comparison of LDL levels after 18 months in patients with known LDL levels

  18 months

• Assessment of stability: Comparison of blood pressure after 18 months

  18 months

• In patients with diabetes: target blood HbA1c level of ≤ 7% or ≤ 53mmol/mol after 9 months.

  9 months

• Assessment of stability in patients with diabetes: Comparison of blood HbA1c levels after 18 months.

  18 months

Study Arms (2)

Group with the medical device "iATROS"

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.

Device: CHD therapy through iATROS medical device

Group without the medical device "iATROS"

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.

Interventions

CHD therapy through iATROS medical device DEVICE

The intervention to be carried out in the treatment group is the use of the therapy control for the treatment of CHD played out via the iATROS medicine product. Patients will receive a suitable and medical device certified measuring device for recording vital parameters. The iATROS app is downloaded to the patient's smartphone and the app is activated by entering a code that identifies the user as a participant in the study. When using the app for the first time, the patient is guided through the first steps of using the app and asked to transfer his or her health data to the app. The therapy control by means of the medication product takes place over the entire duration of the study.

Group with the medical device "iATROS"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 18 years
• Patients diagnosed with ischemic heart disease according to ICD I20 to I25 who also have at least one of the following:
• inpatient stay with acute STEMI/NSTEMI or historic STEMI/NSTEMI; and/or
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• iATROS GmbH: lead

Study Sites (1)

Klinikum der Ludwig-Maximilians-Universität München (Klinikum der Universität München), Medizinische Klinik und Poliklinik I

Munich, Bavaria, 81377, Germany

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Moritz Sinner, PD Dr. med

  Medizinische Klinik I und Poliklinik LMU Klinikum Campus Großhadern

  PRINCIPAL INVESTIGATOR

• Stefan Kääb, Prof.Dr.med.

  Medizinische Klinik I und Poliklinik LMU Klinikum Campus Großhadern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Weyh, M. Sc.

CONTACT

+49 176 856 23 142; paul.weyh@i-atros.com

Georges von Degenfeld, Dr. med.

CONTACT

+49 89 - 95879243; georges.degenfeld@i-atros.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 19, 2023
• Study Start: October 5, 2023
• Primary Completion: April 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)