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New study aims to fix heart risk calculators that fail women

NCT ID NCT06999317

Knowledge-focused Sponsor: Hospital Universitario Virgen Macarena Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at health records from 1.5 million women aged 40-60 to better predict heart disease risk during and after menopause. Current risk tools often miss key factors unique to women. Researchers will use AI to analyze medical history, imaging, and device data to create personalized risk scores. The goal is to help doctors prevent heart attacks and strokes in women earlier and more accurately.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,500,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants are identified retrospectively from electronic health records, imaging archives, and device registries across multiple healthcare systems and countries

Ages

40 to 60 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Self-identified as female in the electronic health record (EHR). Age between 40 and 60 years at the time of data collection/index date. Availability of at least 5-6 years of retrospective data in the EHR, depending on the research objective. At least one healthcare encounter (visit, imaging, lab test, diagnosis, etc.) within the defined age range. For imaging substudies (e.g., RO3-RO5): availability of at least one relevant imaging test (e.g., DXA, digital mammography, cMRI, CCTA, US) during the age range. For signal-based analysis (RO6): presence of ECG monitoring data from implanted devices and at least 2 years of follow-up. Exclusion Criteria: Prior diagnosis of cardiovascular disease before the observation window (only applicable to specific ROs, e.g., RO2, RO4). Insufficient data quality or missing key variables needed for modeling (e.g., absence of blood pressure or lipid profile). Patients with incomplete or inconsistent records (e.g., duplicate IDs, mismatched time frames). For signal-based RO6: hospitalizations or diagnoses unrelated to cardiovascular health that may bias AI model training.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular risk factors Menopausal women Perimenopausal women Real-world data

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.