Coronary Artery DiseaseERKHANCT06091774
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
An observational study of Coronary Artery Disease and Cardiovascular Diseases, run by iATROS GmbH at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Cardiovascular Diseases, Coronary Heart Disease
- What is being tested?
- CHD therapy through iATROS medical device
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 5 Oct 2023to Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥ 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum der Ludwig-Maximilians-Universität München (Klinikum der Universität München), Medizinische Klinik und Poliklinik I
Munich, Bavaria, 81377
Julia Brust, +49 89 4400 72371, Julia.Brust@med.uni-muenchen.de
Moritz Sinner, PD Dr. med.
About this study
Official title: Klinische Studie Zur Untersuchung Und Validierung Eines Therapieverfahrens Zur Einstellung Von Risikofaktoren Bei Patienten Mit Koronarer Herzkrankheit (KHK) Mittels Digitaler Therapiesteuerung
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).
Read the 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.
- Conditions
- Coronary Artery Disease, Cardiovascular Diseases, Coronary Heart Disease, Ischemic Heart Disease
- Being tested
- CHD therapy through iATROS medical device
- Keywords
- eHealth, cardiology, coronary artery disease
- Medical subject headings
- Coronary Artery Disease, Cardiovascular Diseases, Coronary Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHD therapy through iATROS medical deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Comparison of the mean value of the absolute reduction between the treatment and control group of this patient population with regard to statistically significant differences.
Furthermore, intra-group comparison of this patient population per study arm to determine statistically significant effects with regard to LDL reduction by treatment with iATROS over 9 months.
Measured: 9 months
Assessment of stability: Comparison of LDL levels after 18 months in patients with known LDL levels
Comparison of medical parameter LDL (available through standard-of-care treatment) between the two study arms after 18 months study duration.
Measured: 18 months
Assessment of stability: Comparison of blood pressure after 18 months
Comparison of blood pressure values (available through standard-of-care measurements) between the two study arms after 18 months study duration.
Measured: 18 months
In patients with diabetes: target blood HbA1c level of ≤ 7% or ≤ 53mmol/mol after 9 months.
Comparison of the proportion of patients per study arm in percent in the HbA1c target range with regard to statistically significant differences. In addition to an intergroup comparison, an intragroup comparison per study arm will be performed.
Measured: 9 months
Assessment of stability in patients with diabetes: Comparison of blood HbA1c levels after 18 months.
Comparison of medical parameter HbA1c (available through standard-of-care treatment) between the two study arms after 18 months study duration.
Measured: 18 months
In patients with diabetes: absolute reduction in blood HbA1c level after 9 months.
Comparison of the mean absolute reduction in HbA1 levels between the treatment and control groups for statistically significant differences in patients with history of HbA1c levels at inclusion.
Furthermore, intragroup comparison per study arm to determine, whether treatment with iATROS has a statistically significant effect on the reduction of HbA1c levels over 9 months.
Measured: 9 months
In patients with obesity: absolute BMI reduction after 9 months.
Comparison of the mean value of the absolute BMI reduction and the absolute weight reduction in [kg] with regard to the statistical significance of the absolute change between all patients in the treatment and control group. In addition to an intergroup comparison, an intragroup comparison per study arm will be performed.
Measured: 9 months
Assessment of stability in patients with obesity: Comparison of BMI changes after 18 months.
Comparison of BMI values (available through standard-of-care measurement of weight and height which will be combined to report BMI in kg/m^2) between the two study arms after 18 months study duration.
Measured: 18 months
Absolute BMI reduction in patients with initial BMI > 30kg/m2 after 9 months.
Comparison of the mean value of the absolute BMI reduction of this patient collective as well as the mean absolute weight reduction in [kg] with regard to statistical significance of the absolute change between the treatment and the control group. In addition to an intergroup comparison, an intragroup comparison per study arm will be performed.
Measured: 9 months
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.
Comparison of the mean value of the percentage BMI reduction between the treatment and control groups with regard to statistical significance. In addition, a comparison with the predefined target value is to be used to calculate which proportion of the intervention and control groups falls within this target range in [%] before the study period and after 9 months. In addition to an intragroup comparison, an intragroup comparison per study arm will be performed.
Measured: 9 months
For patients with current nicotine abuse: determination of/review of smoking cessation after 9 months.
Query of smoking status and pack years per patient. Comparison of the percentage per study arm, who no longer define themselves as "smokers" and the percentage of patients who have defined themselves as "ex-smokers" for >6 months. Comparison of study arms and intragroup comparison 9 months after inclusion.
Determination of smoking status using the Fagerström test for nicotine dependence (FTND).
Measured: 9 months
Assessment of stability for patients with current nicotine abuse: determination of/review of smoking cessation after 18 months.
Comparison of Fagerström test for nicotine dependence (FTND) scores between the two study arms after 18 months study duration.
Measured: 18 months
Improving health literacy
The study will examine whether an improvement in health literacy can be measured after 9 and 18 months when using digital therapy management via iATROS. The Rasch-scaled short form of the European Health Literacy Survey (HLS-EU-Q16) questionnaire comprises 16 questions that are rated on a 4-level scale, with the answer options focussing on the respective difficulty (very easy, fairly easy, fairly difficult, very difficult). The four answer options are dichotomised, whereby the two categories "very easy" and "fairly easy" were assigned a value of 1 and the two remaining categories a value of 0. Based on the sums achieved, the health literacy of the patients is finally categorised as "insufficient" (sum 0-8), "problematic" (sum 9-12) and "sufficient" (sum 13-16).Since the questionnaires are submitted in the treatment group and the control group both at baseline and after 9 and 18 months, respectively, an intra-group comparison as well as an inter-group comparison is possible.
Measured: 9 months and 18 months
Assessment of stability: Improving health literacy
Comparison of the European Health Literacy Survey (HLS-EU-Q16) scores between the two study arms after 18 months study duration.
Measured: 18 months
Improving patient sovereignty
The study will examine whether the use of iATROS results in an increase in patient sovereignty after the treatment period of 9 and also 18 months. In order to measure this, a short-form of the Patient Activation Measure (PAM-13) will be used. The results are divided into different categories by quantitatively evaluating the results of the questions answered in a four-point Likert scale (not true, hardly true, rather true, exactly true). The total score results from the answers to the individual questions after standardization and is divided into four levels: Level 1 (lack of belief that activation is important, ≤47 points), Level 2 (lack of knowledge and confidence to take action, 47.1-55.1 points), Level 3 (beginning to take action, 55.2-67.0 points) and Level 4 (taking action, ≥67 points). The measurement of PAM-13 at the beginning of the study and after 9 and 18 months allows an intragroup and intergroup comparison.
Measured: 9 months and 18 months
Assessment of stability: Improving patient sovereignty
Comparison of the Patient Activation Measure (PAM-13) scores between the two study arms after 18 months study duration.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start5 Oct 2023
- Primary completionApr 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iATROS GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moritz Sinner, PD Dr. med, Principal investigator, Medizinische Klinik I und Poliklinik LMU Klinikum Campus GroßhadernStefan Kääb, Prof.Dr.med., Principal investigator, Medizinische Klinik I und Poliklinik LMU Klinikum Campus Großhadern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091774
- Sponsor's protocol ID
- 03
- Acronym
- ERKHA
- Status last verified
- Mar 2024
- First submitted
- 29 Sep 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Klinische Studie Zur Untersuchung Und Validierung Eines Therapieverfahrens Zur Einstellung Von Risikofaktoren Bei Patienten Mit Koronarer Herzkrankheit (KHK) Mittels Digitaler Therapiesteuerung
- ClinicalTrials.gov ID
- NCT06091774
- Acronym / sponsor ID
- ERKHA / 03
- Conditions
- Coronary Artery Disease, Cardiovascular Diseases, Coronary Heart Disease, Ischemic Heart Disease
- Keywords
- eHealth, cardiology, coronary artery disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- iATROS GmbHIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with the medical device "iATROS" | – | Device: CHD therapy through iATROS medical devicePatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- ≥ 18 years
- Patients diagnosed with ischemic heart disease according to ICD I20 to I25 who also have at least one of the following:
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHD therapy through iATROS medical deviceThe 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. | Device | Group with the medical device "iATROS" |
Primary outcome
Proportion of patients in target range of LDL or blood pressure
Time frame: 9 months
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).
16 secondary outcomes
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.
Time frame: 9 months
Assessment of stability: Comparison of LDL levels after 18 months in patients with known LDL levels
Time frame: 18 months
Assessment of stability: Comparison of blood pressure after 18 months
Time frame: 18 months
In patients with diabetes: target blood HbA1c level of ≤ 7% or ≤ 53mmol/mol after 9 months.
Time frame: 9 months
Assessment of stability in patients with diabetes: Comparison of blood HbA1c levels after 18 months.
Time frame: 18 months
In patients with diabetes: absolute reduction in blood HbA1c level after 9 months.
Time frame: 9 months
In patients with obesity: absolute BMI reduction after 9 months.
Time frame: 9 months
Assessment of stability in patients with obesity: Comparison of BMI changes after 18 months.
Time frame: 18 months
Absolute BMI reduction in patients with initial BMI > 30kg/m2 after 9 months.
Time frame: 9 months
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.
Time frame: 9 months
For patients with current nicotine abuse: determination of/review of smoking cessation after 9 months.
Time frame: 9 months
Assessment of stability for patients with current nicotine abuse: determination of/review of smoking cessation after 18 months.
Time frame: 18 months
Improving health literacy
Time frame: 9 months and 18 months
Assessment of stability: Improving health literacy
Time frame: 18 months
Improving patient sovereignty
Time frame: 9 months and 18 months
Assessment of stability: Improving patient sovereignty
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moritz Sinner, PD Dr. med principal investigator
Medizinische Klinik I und Poliklinik LMU Klinikum Campus Großhadern
Stefan Kääb, Prof.Dr.med. principal investigator
Medizinische Klinik I und Poliklinik LMU Klinikum Campus Großhadern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Cardiovascular Diseases, run by iATROS GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Weyh, M. Sc. (+49 176 856 23 142, paul.weyh@i-atros.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients in target range of LDL or blood pressure (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.