Risk assessment for chronic coronary heart disease by general practitioners: Using the Cardio Explorer in primary care
| ISRCTN | ISRCTN67912485 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67912485 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | AOK |
| Funders | AOK Niedersachsen, Herz und Gefäßzentrum Bad Bevensen, Exploris Health AG |
- Submission date
- 26/08/2024
- Registration date
- 11/09/2024
- Last edited
- 04/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Coronary heart disease is still considered a widespread disease in Germany despite slightly declining mortality rates. The challenges in the early detection of patients with coronary heart disease in combination with developments in healthcare policy (e.g. limited specialist resources combined with long waiting times) show the considerable need to improve risk assessment in primary care. This study investigates the implementation of an artificial intelligence-based algorithm, the Cardio Explorer. The main goal is to investigate the level of acceptance, usability and trust in the Cardio Explorer by general practitioners.
Who can participate?
People (≥ 50 years of age) who are suspected of having coronary heart disease when they present to their general practitioner. Participants must be insured with AOK Niedersachsen.
What does the study involve?
Participants will be allocated to the control group versus the treatment group based on the time of presenting to the general practitioners (control phase or intervention phase). General participants apply the Cardio Explorer to assess the clinical likelihood of coronary heart disease. Each participant is documented after medical consultation and participants are monitored before and after using claims data from the AOK Niedersachsen.
What are the potential benefits and risks of participating in the study?
General practitioners have access to the Cardio Explorer, which is a non-invasive innovative tool. Participation might reduce unnecessary (invasive) diagnostic procedures that are associated with risks (e.g. vascular injuries and bleeding, embolism and strokes, kidney failure, cardiac arrhythmias). Other causes of the presented symptoms could be recognized more quickly and thus treated more efficiently. The input data for the Cardio Explorer is determined as part of routine blood analysis and assessment of the medical history. Accordingly, additional medical procedures are not needed to apply the Cardio Explorer. General practitioners are free to use additional tools to assess the individual risk of coronary heart disease.
Where is the study run from?
General practitioner practices in Lower Saxony in Germany.
When is the study starting and how long is it expected to run for?
Preparations for the study began in February 2023. Data assessment (control phase followed by the intervention phase) takes place from November 2024 to December 2025. The study is expected to end in July 2026 with the submission of a final report.
Who is funding the study?
The insurance company AOK Niedersachsen
Exploris Health AG provides pseudo-anonymised input data from Cardio Explorer
Who is the main contact?
Dr. Julia Wolff, Dr. Deborah Meier
cardioexplorer@iges.com
Contact information
Public, Scientific
Friedrichstraße 180
Berlin
10117
Germany
| Phone | +49 30 230 809 44 |
|---|---|
| cardioexplorer@iges.com |
Principal investigator
Klinik für Kardiologie, HGZ Bad Bevensen, Römstedter Straße 25
Bad Bevensen
29549
Germany
| Phone | +49 05821 82-1703 |
|---|---|
| ba.remppis@hgz-bb.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentred controlled non-randomized study with prospective observation of the intervention and control group (quasi-experimental study design) |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Pilot study on using the Cardio Explorer for coronary heart disease risk assessment in primary care |
| Study objectives | 1. Primary hypothesis: the results of the risk assessment provided by the Cardio Explorer and the medical (diagnostic) procedure of the general practitioner match by at least 90% 2. Secondary hypothesis: The benefit of using the Cardio Explorer in primary care rated by general practitioners is high. 3. Secondary hypothesis: Confidence in the Cardio Explorer rated by general practitioners is high. 4. Secondary hypothesis: The level of usability and practicability of the Cardio Explorer in primary care rated by general practitioners is good. 5. Secondary hypothesis: The use of the Cardio Explorer decreases (invasive) diagnostic procedures. 6. Secondary hypothesis: The use of the Cardio Explorer decreases contacts with cardiologists. |
| Ethics approval(s) |
Approved 08/09/2023, Ethics Committee of the Medical Association of Lower Saxony (Ethikkommission bei der Ärztekammer Niedersachsen) (Berliner Allee 20, Hannover, 30175, Germany; +49 511 3802-3102; ethikkommission@aekn.de), ref: BO/28/2023 |
| Health condition(s) or problem(s) studied | Coronary heart disease |
| Intervention | This is a multicentre, controlled, non-randomized study with prospective observation of both the intervention and control groups (quasi-experimental study design). Patients included in the study during the control phase will be assigned to the control group and will receive standard care. In the subsequent intervention phase, general practitioners (GPs) will use the Cardio Explorer, and patients included during this period will be assigned to the treatment group. Data assessment will be based on three sources: First, during both the control and intervention phases, GPs will complete an electronic Case Report Form to record patient information and medical procedures. GPs will also participate in qualitative interviews and standardized questionnaires to evaluate the usability of the Cardio Explorer. Secondly, claims data provided by AOK Niedersachsen on diagnostic procedures will be retrieved for up to one year before, and six months after, the control and treatment phases respectively. Thirdly, input data from the Cardio Explorer will be assessed, but only in the treatment group. During the intervention phase, GPs will use the Cardio Explorer during medical consultations with patients suspected of having coronary artery disease (CAD). The Cardio Explorer is a software-based medical device approved for the European market (following Directive 98/79/EC) that estimates the clinical likelihood of CAD. The input data for the Cardio Explorer consists of medical history, vital data, and laboratory values derived from a routine blood test. GPs will determine the corresponding input data as part of a standardized anamnestic examination and routine blood analysis. The Cardio Explorer will generate a quantitative risk score with corresponding risk classification: based on the individual risk score, patients will be categorized into one of four risk classes, indicating the likelihood of CAD and the recommended diagnostic actions. The Cardio Explorer can be accessed from a local computer using any Internet browser. |
| Intervention type | Other |
| Primary outcome measure(s) |
Concordance between the recommended medical actions based on the Cardio Explorer risk class and the medical (diagnostic) procedure, both assessed during the intervention phase. The Cardio Explorer risk class is determined for each patient at one point throughout individual treatment (application of the Cardio Explorer). The medical (diagnostic) procedure determined by the GP is assessed at the end of treatment for each patient using a self-developed questionnaire (electronic Case Report Form). |
| Key secondary outcome measure(s) |
1. The GPs’ ratings on the benefit of facilitation of risk assessment are measured using a self-developed questionnaire at the end of treatment for each patient (electronic Case Report Form). Ratings on the benefit of the risk assessment derived from qualitative interviews with GPs at the end of the intervention phase are considered as well. |
| Completion date | 31/07/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 50 Years |
| Sex | All |
| Target sample size at registration | 446 |
| Key inclusion criteria | 1. Insured with AOKN at the time of inscription and for the duration of study 2. Age ≥50 years 3. Suspected coronary heart disease 4. Residing in Niedersachsen or bordering area |
| Key exclusion criteria | 1. Pre-existing diagnosis of coronary heart disease 2. Acute coronary syndrome / other medical emergencies 3. Participation in any clinical study (self-report) 4. Participation in the control group disqualifies from participation in the intervention group |
| Date of first enrolment | 01/11/2024 |
| Date of final enrolment | 31/12/2025 |
Locations
Countries of recruitment
- Germany
Study participating centre
-
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to privacy and ethical concerns with respect to sensitive health data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/06/2025: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/08/2025 to 31/12/2025.
2. Contact details updated.
17/01/2025: Sponsor contact details updated.
27/08/2024: Study's existence confirmed by the Ethics Committee of the Medical Association of Lower Saxony (Ethikkommission bei der Ärztekammer Niedersachsen).
