A Retrospective Observational Substudy of LDL Cholesterol Changes and Treatment-Target Attainment in the AIDAVA G1 Post-Myocardial Infarction Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Percentage of participants with LDL-C below 1.4 mmol/L at follow-up.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in the AIDAVA G1 cardiovascular cohort
- •Available baseline and follow-up LDL-C measurements with ascertainable measurement dates.
排除标准
- •Absence of the required paired baseline and follow-up LDL-C measurements
- •Missing patient consent
研究组 & 干预措施
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.
结局指标
主要结局
Percentage of participants with LDL-C below 1.4 mmol/L at follow-up.
时间窗: Day 365
Percentage of participants with LDL-C below 1.8 mmol/L at follow-up.
时间窗: Day 365
次要结局
未报告次要终点