Cardiovascular Disease Prevention Trial Protocols and Approvals

A 2026 dataset from figshare by Luigi Russo containing ethics committee protocols and approvals for a clinical trial. The trial enrolled 650 healthy participants over 40 years old to assess the impact of communicating Polygenic Risk Scores (PRS) for cardiovascular disease on lifestyle behaviors. It includes documentation from the PHC study, a single-arm trial registered at ClinicalTrials.gov (NCT06888466).

Use Cases

• Analyze ethics committee approval timelines and conditions for trials involving genetic risk disclosure.
• Study the structure of informed consent documents for trials combining polygenic risk scores (PRS) with lifestyle interventions.
• Review protocol amendments related to secondary endpoints like SCORE2 and LDL-cholesterol level assessments.
• Examine documentation for participant eligibility criteria, such as the 10-year CVD risk threshold of less than 10% on SCORE2 charts.

Strengths

• Documentation is recent, last updated in April 2026.
• Covers a specific, well-defined trial with 650 enrolled participants.
• Trial is registered with a public identifier (NCT06888466), aiding verification.

Limitations

• Small scale at 5.2 MB, suggesting limited raw data; likely contains only procedural documents.
• Unknown row and column counts for any potential tabular data within the ZIP archive.
• Geographic coverage of the trial participants is unspecified, limiting generalizability analysis.

Provenance

Source

figshare, authored by Luigi Russo.

Collection Method

Documentation generated as part of the PHC single-arm clinical trial.

Time Range

Trial documentation circa 2026; specific temporal coverage of the trial itself is not stated.

Freshness

Last updated 2026-04-06.

Geography

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