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NCT Number: NCT07839845

AIDAVA G1 LDL-C Substudy Protocol

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

North Estonia Medical Centre

Tallinn, Estonia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participation in the G1 cardiovascular cohort and available baseline and follow-up LDL-C measurements with ascertainable measurement dates.

Exclusion criteria

Absence of the required paired measurements.

Treatment and study plan

Primary outcomes

  1. Percentage of participants with LDL-C below 1.8 mmol/L at follow-up.

    Time frame: Day 365

  2. Percentage of participants with LDL-C below 1.4 mmol/L at follow-up.

    Time frame: Day 365

Interested in participating?

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Sponsors and collaborators

Lead sponsor

North Estonia Medical Centre

Other

Collaborators

  • Maastricht University
  • Medical University of Graz

Registry information

Official study title

A Retrospective Observational Substudy of LDL Cholesterol Changes and Treatment-Target Attainment in the AIDAVA G1 Post-Myocardial Infarction Cohort

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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