Myocardial InfarctionNCT07839845
AIDAVA G1 LDL-C Substudy Protocol
An observational study of Myocardial Infarction, run by North Estonia Medical Centre at 1 site in Estonia.
Trial summary
This retrospective substudy describes low-density lipoprotein cholesterol (LDL-C) changes and treatment-target attainment among patients with previous myocardial infarction who participated in the AIDAVA first-generation (G1) prototype evaluation in Estonia, Austria and the Netherlands. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- How many people
- 37 participants
- Where
- 1 siteEstonia
- Study dates
- 1 Jul 2024to 1 Jul 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: Adults from the AIDAVA G1 cardiovascular cohort at North Estonia Medical Centre, Tallinn; Medical University of Graz, Graz; and Maastricht University Medical Centre+, Maastricht, with a documented history of type 1 myocardial infarction and permission for the relevant secondary use of their data. The source cohort comprised digitally active adults with available medical data, smartphone ownership/use, a confirmed symptomatic type 1 myocardial infarction and written informed consent.
Who may be able to join
- Participation in the AIDAVA G1 cardiovascular cohort
- Available baseline and follow-up LDL-C measurements with ascertainable measurement dates.
Who cannot join
- Absence of the required paired baseline and follow-up LDL-C measurements
- Missing patient consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Observational Substudy of LDL Cholesterol Changes and Treatment-Target Attainment in the AIDAVA G1 Post-Myocardial Infarction Cohort
This retrospective substudy describes low-density lipoprotein cholesterol (LDL-C) changes and treatment-target attainment among patients with previous myocardial infarction who participated in the AIDAVA first-generation (G1) prototype evaluation in Estonia, Austria and the Netherlands. Existing study data and clinical records are analysed. The LDL-C research question was developed after the original evaluation was planned and was not its prespecified efficacy endpoint. No additional intervention, treatment assignment, visit or blood sampling is introduced by this substudy. Findings are exploratory and cannot establish a causal effect of AIDAVA participation.
Read the detailed description
AIDAVA developed an AI-assisted system for integrating, curating and reusing personal health data. The original evaluation addressed technical performance, usability and acceptance. Cardiovascular participants contributed existing clinical records and longitudinal data, including home blood-pressure measurements, with support from study nurses and data curators. The cardiovascular protocol also envisaged automatic SMART risk-score assessment.
This registration covers only the secondary LDL-C analysis of the G1 post-myocardial infarction cohort. It does not register the full AIDAVA project, breast-cancer evaluation or G2 prototype evaluation. The original evaluation was not registered. This summary was prepared after the LDL-C analysis and does not represent prospective specification of its hypotheses, outcomes or analysis methods.
- Conditions
- Myocardial Infarction
- Keywords
- LDL-C
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AIDAVA G1 post-myocardial infarction cohort. | Previous participation in two-week G1 health-data curation and prototype testing with nurse/curator guidance, and home blood-pressure data collection. These activities occurred in the original evaluation; no exposure is assigned in this retrospective substudy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with LDL-C below 1.8 mmol/L at follow-up.
Measured: Day 365
Percentage of participants with LDL-C below 1.4 mmol/L at follow-up.
Measured: Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Jul 2024
- Primary completion1 Jun 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Estonia Medical Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University, Medical University of Graz
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839845
- Sponsor's protocol ID
- AIDAVAG1LDLSubStudy
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As per the Ethics Committee approval
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Observational Substudy of LDL Cholesterol Changes and Treatment-Target Attainment in the AIDAVA G1 Post-Myocardial Infarction Cohort
- ClinicalTrials.gov ID
- NCT07839845
- Acronym / sponsor ID
- AIDAVAG1LDLSubStudy
- Conditions
- Myocardial Infarction
- Keywords
- LDL-C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- North Estonia Medical CentreUniversity, hospital or other
- Collaborators
- Maastricht University, Medical University of Graz
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 24 Sep 2026 (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 retrospective substudy describes low-density lipoprotein cholesterol (LDL-C) changes and treatment-target attainment among patients with previous myocardial infarction who participated in the AIDAVA first-generation (G1) prototype evaluation in Estonia, Austria and the Netherlands. Existing study data and clinical records are analysed. The LDL-C research question was developed after the original evaluation was planned and was not its prespecified efficacy endpoint. No additional intervention, treatment assignment, visit or blood sampling is introduced by this substudy. Findings are exploratory and cannot establish a causal effect of AIDAVA participation.
Detailed description
AIDAVA developed an AI-assisted system for integrating, curating and reusing personal health data. The original evaluation addressed technical performance, usability and acceptance. Cardiovascular participants contributed existing clinical records and longitudinal data, including home blood-pressure measurements, with support from study nurses and data curators. The cardiovascular protocol also envisaged automatic SMART risk-score assessment.
This registration covers only the secondary LDL-C analysis of the G1 post-myocardial infarction cohort. It does not register the full AIDAVA project, breast-cancer evaluation or G2 prototype evaluation. The original evaluation was not registered. This summary was prepared after the LDL-C analysis and does not represent prospective specification of its hypotheses, outcomes or analysis methods.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AIDAVA G1 post-myocardial infarction cohort. | – | –Previous participation in two-week G1 health-data curation and prototype testing with nurse/curator guidance, and home blood-pressure data collection. These activities occurred in the original evaluation; no exposure is assigned in this retrospective substudy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults from the AIDAVA G1 cardiovascular cohort at North Estonia Medical Centre, Tallinn; Medical University of Graz, Graz; and Maastricht University Medical Centre+, Maastricht, with a documented history of type 1 myocardial infarction and permission for the relevant secondary use of their data. The source cohort comprised digitally active adults with available medical data, smartphone ownership/use, a confirmed symptomatic type 1 myocardial infarction and written informed consent.
Key inclusion criteria (2 listed)
- Participation in the AIDAVA G1 cardiovascular cohort
- Available baseline and follow-up LDL-C measurements with ascertainable measurement dates.
Key exclusion criteria (2 listed)
- Absence of the required paired baseline and follow-up LDL-C measurements
- Missing patient consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of participants with LDL-C below 1.8 mmol/L at follow-up.
Time frame: Day 365
Percentage of participants with LDL-C below 1.4 mmol/L at follow-up.
Time frame: Day 365
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. As per the Ethics Committee approval
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Myocardial Infarction, run by North Estonia Medical Centre at 1 site in Estonia.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 25 Sep 2026. 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 Estonia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with LDL-C below 1.8 mmol/L at follow-up. (time frame: Day 365). The study lists 2 primary outcomes in all. 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 25 Sep 2026.