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AI could spot hidden heart risks in menopausal women

NCT ID NCT07695376

Knowledge-focused Sponsor: Biogipuzkoa Health Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study aims to develop an artificial intelligence tool that can better predict a woman's risk of heart disease during the menopausal transition. Researchers will collect health data from 3,000 women aged 40 to 60 across Europe and Colombia, including blood tests, blood pressure readings, and electronic health records. The goal is to create a personalized risk score that could lead to earlier prevention strategies, though no treatments are being tested in this observational study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a personalized AI tool that helps doctors identify women at high risk for heart disease during menopause, enabling earlier prevention.
What could go wrong
This is an observational study, so it does not test a treatment. The AI models may not be accurate enough for widespread use, and results may not apply to all populations.

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 3,000 people

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

Started

Mar 2026

Expected to finish

Nov 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

The study population will be recruited in four European Union countries: Croatia, Spain (Andalusia and The Basque Country - Gipuzkoa), Greece and Lithuania; and in Colombia. A prospective cohort of 3,000 women aged 40-60 will be recruited, with each partner contributing 500 participants. Eligible women may be invited to participate by their regular healthcare provider or may express their interest independently. To maximize representativeness, information about the study will be disseminated via multiple communication channels, including social media platforms (e.g., LinkedIn, Facebook, Bluesky, X). Women who express interest will be contacted by the CARAMEL research team, and detailed study documentation will be provided.

Ages

40 to 60 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Women 40 to 60 years of age, at recruitment. * Ability to understand and complete the required informed consent for the study. * Women who are covered by the corresponding healthcare system operating at each clinical site. Exclusion Criteria: * Severe comorbidity with less than 24 months life expectancy. * Lack of basic digital skills to use or carry a smartphone and wearable devices.

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As listed by the trial registrant

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

Artificial intelligence (AL) Cardiovascular (CV) risk Cardiovascular disease risk factor Menopause Perimenopause Women (between 30 to 60 years old)

How to take part

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

  1. The places running it

    6 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Biogipuzkoa Health Research Institute

    RECRUITING

    San Sebastián, Spain

  • Ethniko Kai Kapodistriako Panepistimio Athinon

    RECRUITING

    Athens, Greece

  • Fundacion Para La Gestion de La Investigacion En Salud de Sevilla

    RECRUITING

    Seville, Spain

  • Keralty SAS

    NOT_YET_RECRUITING

    Bogotá, Colombia

  • Magdalena - Klinika Za Kardiovaskularne Bolesti Medicinskog Fakultetasveucilista J.J. Strossmayera U Osijeku Ustanova

    NOT_YET_RECRUITING

    Krapinske Toplice, Croatia

  • Viesoji Istaiga Vilniaus Universiteto Ligonine Santaros Klinikos

    NOT_YET_RECRUITING

    Vilnius, Lithuania

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