PerimenopauseCARAMEL-OSNCT07695376
CARAMEL Observational Study
An observational study of Perimenopause and Menopause, run by Biogipuzkoa Health Research Institute at 6 sites in 5 countries.
Trial summary
CARAMEL is a project funded by the European Commission under the Horizon Europe programme. Its aim is to develop a personalized prevention approach based on state-of-the-art artificial intelligence models for cardiovascular risk stratification in women aged 40-60 years. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopause, Menopause, Cardiovascular (CV) Risk
- How many people
- 3,000 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 16 Mar 2026to Nov 2028
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Severe comorbidity with less than 24 months life expectancy.
- Lack of basic digital skills to use or carry a smartphone and wearable devices.
Trial locations and contacts
6 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 5 countries
Spain2 sites, 2 recruiting
- Recruiting
Biogipuzkoa Health Research Institute
San Sebastián
Project Manager Primary Care - OSIs Research Unit, +34943006112, unidadinvestigaciongip@osakidetza.eus
- Recruiting
Fundacion Para La Gestion de La Investigacion En Salud de Sevilla
Seville
Luis G Luque Romero, (+34)600143635, investigacion.daljsevn.sspa@juntadeandalucia.es
Colombia1 site, 1 recruiting
- Not yet recruiting
Keralty SAS
Bogotá
Kelly R Chacon, (+57)6252111 ext. 5714599, krchacon@keralty.com
Croatia1 site, 1 recruiting
- Not yet recruiting
Magdalena - Klinika Za Kardiovaskularne Bolesti Medicinskog Fakultetasveucilista J.J. Strossmayera U Osijeku Ustanova
Krapinske Toplice
CARAMEL Project Manager, (+385)915611387, caramel@magdalena.hr
Greece1 site, 1 recruiting
- Recruiting
Ethniko Kai Kapodistriako Panepistimio Athinon
Athens
Irene Lambrinoudaki, (+30)2107462002 ext. 3, ilambrinoudaki@hotmail.com
Lithuania1 site, 1 recruiting
- Not yet recruiting
Viesoji Istaiga Vilniaus Universiteto Ligonine Santaros Klinikos
Vilnius
Zaneta Petrulioniene, (+37)061839391, zaneta.petrulioniene@santa.lt
About this study
Official title: CArdiovascular Risk Assessment Via Multimodal Data Analysis Enabling Personalised Prevention Strategies Targeting MEnopausaL Women - Observational Study
CARAMEL is a project funded by the European Commission under the Horizon Europe programme. Its aim is to develop a personalized prevention approach based on state-of-the-art artificial intelligence models for cardiovascular risk stratification in women aged 40-60 years. These models are trained using large amounts of multi-source data and complemented by digital self-assessment and self-management tools. The CARAMEL consortium brings together a diverse group of 25 organizations, including technology companies and research centers, clinical institutions, as well as experts in ethics, law, and communication.
The CARAMEL-OS study is an observational study aimed at prospectively completing the proposed personalized cardiovascular risk stratification model for women aged 40-60 years that will be developed during the earlier phases of the overall CARAMEL project (https://www.caramel-project.eu/).
Read more
The study has a purely observational design, and patient stratification will not entail any clinical intervention. The data collected will be used to complete the design of the personalized stratification model, as well as to develop and validate the performance of the predictive models in an independent prospective cohort, distinct from the retrospective cohort initially used. The performance of the models developed using retrospective data will be assessed in terms of accuracy, discrimination, calibration, and other relevant metrics. In addition, the study will enable the development of new predictive models with short-term prediction horizons, incorporating additional variables that are not available retrospectively.
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.
Read the detailed description
A prospective observational study involving 3,000 women across six clinical sites will be conducted to generate a comprehensive multi-source dataset for the development of cardiovascular disease (CVD) risk assessment models. In addition to socioeconomic, clinical, biochemical, and imaging data, the study will use novel non-invasive technologies to collect additional potentially relevant variables, aiming to improve understanding of female-specific cardiovascular risk factors and biological changes around menopause age. By refining the CARAMEL stratification scheme based on the most effective approaches, the project aims to provide innovative tools for personalized CVD prevention and risk stratification. This ambitious and integrative approach is expected to advance precision medicine in women's cardiovascular health, support clinical decision-making, and inform future preventive strategies at both individual and population levels. Central to these strategies is the development of the datApp - a mobile application designed to serve as a personalised companion for women throughout their menopausal transition.
- Conditions
- Perimenopause, Menopause, Cardiovascular (CV) Risk, Women (Between 30 to 60 Years Old), Cardiovascular Disease Risk Factor, Artificial Intelligence (Al)
- Keywords
- Women-specific risk factors, Cardiovascular (CV) Risk, Perimenopause, Menopause, Prediction models, Patient reported outcomes (PROM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 3,000 women aged 40-60 recruited in four European Union countries and Colombia. | The study population will be recruited in five sites belonging to four European Union countries: Croatia, Spain (Andalusia and The Basque Country - Gipuzkoa), Greece and Lithuania; and one South America country that is Colombia. A prospective cohort of 3,000 women aged 40-60 will be recruited, with each partner contributing 500 participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypertension
Incidence of hypertension will be assessed by measuring blood pressure during the baseline and final study visits, as well as by reviewing the diagnosis of hypertension recorded in the electronic health records. Participants enrolled during a self-monitoring month will be asked to measure their blood pressure twice daily throughout 1 month.
Measured: From enrollment to program completion, spanning 21-24 months depending on the enrollment date.
Incidence of dyslipidaemia
Incidence of dyslipidaemia will be assessed through blood tests measuring HDL cholesterol, LDL cholesterol, total cholesterol, and triglyceride levels at the baseline and final study visits, as well as by reviewing diagnoses of dyslipidaemia recorded in the electronic health records.
Measured: From enrollment to program completion, lasting 21-24 months depending on the enrollment date.
Incidence of diabetes mellitus
Incidence of diabetes mellitus will be assessed through blood tests measuring glomerular filtration rate, albumin-to-creatinine ratio, glucose and glycated hemoglobin levels at the baseline and final study visits, as well as by reviewing diagnoses of diabetes mellitus recorded in the electronic health records.
Measured: From enrollment to program completion, lasting 21-24 months depending on the enrollment date.
Incidence of cardiovascular disease
The incidence of cardiovascular disease will be assessed through the diagnosis of the following conditions: myocardial infarction, chronic coronary syndrome, peripheral arterial disease, and stroke. This information will be collected through a structured medical history interview and by reviewing the electronic health records. These data will be collected during the baseline visit and the final visit.
Measured: From enrollment to program completion, spanning 21-24 months depending on the enrollment date.
Secondary outcomes (1)
Mortality of cardiovascular events.
Mortality of cardiovascular events will be assessed through review of electronic health records, collecting information on new cardiovascular events and mortality occurring during the follow-up period and identified at the final assessment.
Measured: From enrollment to program completion, spanning 21-24 months depending on the enrollment date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start16 Mar 2026
- Primary completionMay 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for PerimenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Biogipuzkoa Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Centro de Tecnologías de Interacción Visual y Comunicaciones Vicomtech, Keralty SAS, Particle Summary, iBreve Limited, Magdalena Clinic, Andaluz Health Service, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla, Viesoji Istaiga Vilniaus Universiteto Ligonine Santaros Klinikos, Asociación Centro de Investigación Cooperativa en Biociencias, Ulma Medical Technologies S Coop, Smartnanosenose Innovation, ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695376
- Sponsor's protocol ID
- PI2025166 (PS)
- Acronym
- CARAMEL-OS
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mazzolai L, Teixido-Tura G, Lanzi S, Boc V, Bossone E, Brodmann M, Bura-Riviere A, De Backer J, Deglise S, Della Corte A, Heiss C, Kaluzna-Oleksy M, Kurpas D, McEniery CM, Mirault T, Pasquet AA, Pitcher A, Schaubroeck HAI, Schlager O, Sirnes PA, Sprynger MG, Stabile E, Steinbach F, Thielmann M, van Kimmenade RRJ, Venermo M, Rodriguez-Palomares JF; ESC Scientific Document Group. 2024 ESC Guidelines for the management of peripheral arterial and aortic diseases. Eur Heart J. 2024 Sep 29;45(36):3538-3700. doi: 10.1093/eurheartj/ehae179. No abstract available.
PubMed 39210722Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.
PubMed 39210710Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264. doi: 10.1016/j.jacc.2018.08.1038. Epub 2018 Aug 25. No abstract available.
PubMed 30153967American Diabetes Association Professional Practice Committee. 1. Improving Care and Promoting Health in Populations: Standards of Care in Diabetes-2025. Diabetes Care. 2025 Jan 1;48(1 Suppl 1):S14-S26. doi: 10.2337/dc25-S001.
PubMed 39651974Cherla A, Kyriopoulos I, Pearcy P, Tsangalidou Z, Hajrulahovic H, Theodorakis P, Andersson CE, Mehra MR, Mossialos E. Trends in avoidable mortality from cardiovascular diseases in the European Union, 1995-2020: a retrospective secondary data analysis. Lancet Reg Health Eur. 2024 Sep 27;47:101079. doi: 10.1016/j.lanepe.2024.101079. eCollection 2024 Dec.
PubMed 39397877McCarthy CP, Bruno RM, McEvoy JW, Touyz RM. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension: what is new in pharmacotherapy? Eur Heart J Cardiovasc Pharmacother. 2025 Feb 8;11(1):7-9. doi: 10.1093/ehjcvp/pvae084. No abstract available.
PubMed 39439212Rajput D, Wang WJ, Chen CC. Evaluation of a decided sample size in machine learning applications. BMC Bioinformatics. 2023 Feb 14;24(1):48. doi: 10.1186/s12859-023-05156-9.
PubMed 36788550Kouz K, Monge Garcia MI, Cerutti E, Lisanti I, Draisci G, Frassanito L, Sander M, Ali Akbari A, Frey UH, Grundmann CD, Davies SJ, Donati A, Ripolles-Melchor J, Garcia-Lopez D, Vojnar B, Gayat E, Noll E, Bramlage P, Saugel B. Intraoperative hypotension when using hypotension prediction index software during major noncardiac surgery: a European multicentre prospective observational registry (EU HYPROTECT). BJA Open. 2023 May 4;6:100140. doi: 10.1016/j.bjao.2023.100140. eCollection 2023 Jun.
PubMed 37588176Lopez-Lopez JP, Garcia-Pena AA, Martinez-Bello D, Gonzalez AM, Perez-Mayorga M, Munoz Velandia OM, Ruiz-Uribe G, Campo A, Rangarajan S, Yusuf S, Lopez-Jaramillo P. External validation and comparison of six cardiovascular risk prediction models in the Prospective Urban Rural Epidemiology (PURE)-Colombia study. Eur J Prev Cardiol. 2025 May 12;32(7):564-572. doi: 10.1093/eurjpc/zwae242.
PubMed 39041366SCORE2-Diabetes Working Group and the ESC Cardiovascular Risk Collaboration. SCORE2-Diabetes: 10-year cardiovascular risk estimation in type 2 diabetes in Europe. Eur Heart J. 2023 Jul 21;44(28):2544-2556. doi: 10.1093/eurheartj/ehad260.
PubMed 37247330Goldenholz DM, Sun H, Ganglberger W, Westover MB. Sample Size Analysis for Machine Learning Clinical Validation Studies. Biomedicines. 2023 Feb 23;11(3):685. doi: 10.3390/biomedicines11030685.
PubMed 36979665Powell-Wiley TM, Baumer Y, Baah FO, Baez AS, Farmer N, Mahlobo CT, Pita MA, Potharaju KA, Tamura K, Wallen GR. Social Determinants of Cardiovascular Disease. Circ Res. 2022 Mar 4;130(5):782-799. doi: 10.1161/CIRCRESAHA.121.319811. Epub 2022 Mar 3.
PubMed 35239404NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet. 2021 Sep 11;398(10304):957-980. doi: 10.1016/S0140-6736(21)01330-1. Epub 2021 Aug 24.
PubMed 34450083SCORE2 working group and ESC Cardiovascular risk collaboration. SCORE2 risk prediction algorithms: new models to estimate 10-year risk of cardiovascular disease in Europe. Eur Heart J. 2021 Jul 1;42(25):2439-2454. doi: 10.1093/eurheartj/ehab309.
PubMed 34120177Liu W, Laranjo L, Klimis H, Chiang J, Yue J, Marschner S, Quiroz JC, Jorm L, Chow CK. Machine-learning versus traditional approaches for atherosclerotic cardiovascular risk prognostication in primary prevention cohorts: a systematic review and meta-analysis. Eur Heart J Qual Care Clin Outcomes. 2023 Jun 21;9(4):310-322. doi: 10.1093/ehjqcco/qcad017.
PubMed 36869800
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CArdiovascular Risk Assessment Via Multimodal Data Analysis Enabling Personalised Prevention Strategies Targeting MEnopausaL Women - Observational Study
- ClinicalTrials.gov ID
- NCT07695376
- Acronym / sponsor ID
- CARAMEL-OS / PI2025166 (PS)
- Conditions
- Perimenopause, Menopause, Cardiovascular (CV) Risk, Women (Between 30 to 60 Years Old), Cardiovascular Disease Risk Factor, Artificial Intelligence (Al)
- Keywords
- Women-specific risk factors, Cardiovascular (CV) Risk, Perimenopause, Menopause, Prediction models, Patient reported outcomes (PROM)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Biogipuzkoa Health Research InstituteUniversity, hospital or other
- Collaborators
- Fundación Centro de Tecnologías de Interacción Visual y Comunicaciones Vicomtech, Keralty SAS, Particle Summary, iBreve Limited, Magdalena Clinic, Andaluz Health Service, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla, Viesoji Istaiga Vilniaus Universiteto Ligonine Santaros Klinikos, Asociación Centro de Investigación Cooperativa en Biociencias, Ulma Medical Technologies S Coop, Smartnanosenose Innovation, ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CARAMEL is a project funded by the European Commission under the Horizon Europe programme. Its aim is to develop a personalized prevention approach based on state-of-the-art artificial intelligence models for cardiovascular risk stratification in women aged 40-60 years. These models are trained using large amounts of multi-source data and complemented by digital self-assessment and self-management tools. The CARAMEL consortium brings together a diverse group of 25 organizations, including technology companies and research centers, clinical institutions, as well as experts in ethics, law, and communication.
The CARAMEL-OS study is an observational study aimed at prospectively completing the proposed personalized cardiovascular risk stratification model for women aged 40-60 years that will be developed during the earlier phases of the overall CARAMEL project (https://www.caramel-project.eu/).
The study has a purely observational design, and patient stratification will not entail any clinical intervention. The data collected will be used to complete the design of the personalized stratification model, as well as to develop and validate the performance of the predictive models in an independent prospective cohort, distinct from the retrospective cohort initially used. The performance of the models developed using retrospective data will be assessed in terms of accuracy, discrimination, calibration, and other relevant metrics. In addition, the study will enable the development of new predictive models with short-term prediction horizons, incorporating additional variables that are not available retrospectively.
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.
Detailed description
A prospective observational study involving 3,000 women across six clinical sites will be conducted to generate a comprehensive multi-source dataset for the development of cardiovascular disease (CVD) risk assessment models. In addition to socioeconomic, clinical, biochemical, and imaging data, the study will use novel non-invasive technologies to collect additional potentially relevant variables, aiming to improve understanding of female-specific cardiovascular risk factors and biological changes around menopause age. By refining the CARAMEL stratification scheme based on the most effective approaches, the project aims to provide innovative tools for personalized CVD prevention and risk stratification. This ambitious and integrative approach is expected to advance precision medicine in women's cardiovascular health, support clinical decision-making, and inform future preventive strategies at both individual and population levels. Central to these strategies is the development of the datApp - a mobile application designed to serve as a personalised companion for women throughout their menopausal transition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3,000 women aged 40-60 recruited in four European Union countries and Colombia. | – | –The study population will be recruited in five sites belonging to four European Union countries: Croatia, Spain (Andalusia and The Basque Country - Gipuzkoa), Greece and Lithuania; and one South America country that is Colombia. A prospective cohort of 3,000 women aged 40-60 will be recruited, with each partner contributing 500 participants. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Severe comorbidity with less than 24 months life expectancy.
- Lack of basic digital skills to use or carry a smartphone and wearable devices.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of hypertension
Time frame: From enrollment to program completion, spanning 21-24 months depending on the enrollment date.
Incidence of hypertension will be assessed by measuring blood pressure during the baseline and final study visits, as well as by reviewing the diagnosis of hypertension recorded in the electronic health records. Participants enrolled during a self-monitoring month will be asked to measure their blood pressure twice daily throughout 1 month.
Incidence of dyslipidaemia
Time frame: From enrollment to program completion, lasting 21-24 months depending on the enrollment date.
Incidence of dyslipidaemia will be assessed through blood tests measuring HDL cholesterol, LDL cholesterol, total cholesterol, and triglyceride levels at the baseline and final study visits, as well as by reviewing diagnoses of dyslipidaemia recorded in the electronic health records.
Incidence of diabetes mellitus
Time frame: From enrollment to program completion, lasting 21-24 months depending on the enrollment date.
Incidence of diabetes mellitus will be assessed through blood tests measuring glomerular filtration rate, albumin-to-creatinine ratio, glucose and glycated hemoglobin levels at the baseline and final study visits, as well as by reviewing diagnoses of diabetes mellitus recorded in the electronic health records.
Incidence of cardiovascular disease
Time frame: From enrollment to program completion, spanning 21-24 months depending on the enrollment date.
The incidence of cardiovascular disease will be assessed through the diagnosis of the following conditions: myocardial infarction, chronic coronary syndrome, peripheral arterial disease, and stroke. This information will be collected through a structured medical history interview and by reviewing the electronic health records. These data will be collected during the baseline visit and the final visit.
1 secondary outcome
Mortality of cardiovascular events.
Time frame: From enrollment to program completion, spanning 21-24 months depending on the enrollment date.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Background: PubMed 39210722Mazzolai L, Teixido-Tura G, Lanzi S, Boc V, Bossone E, Brodmann M, Bura-Riviere A, De Backer J, Deglise S, Della Corte A, Heiss C, Kaluzna-Oleksy M, Kurpas D, McEniery CM, Mirault T, Pasquet AA, Pitcher A, Schaubroeck HAI, Schlager O, Sirnes PA, Sprynger MG, Stabile E, Steinbach F, Thielmann M, van Kimmenade RRJ, Venermo M, Rodriguez-Palomares JF; ESC Scientific Document Group. 2024 ESC Guidelines for the management of peripheral arterial and aortic diseases. Eur Heart J. 2024 Sep 29;45(36):3538-3700. doi: 10.1093/eurheartj/ehae179. No abstract available.
- Background: PubMed 39210710Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.
- Background: PubMed 30153967Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264. doi: 10.1016/j.jacc.2018.08.1038. Epub 2018 Aug 25. No abstract available.
- Background: PubMed 39651974American Diabetes Association Professional Practice Committee. 1. Improving Care and Promoting Health in Populations: Standards of Care in Diabetes-2025. Diabetes Care. 2025 Jan 1;48(1 Suppl 1):S14-S26. doi: 10.2337/dc25-S001.
- Background: PubMed 39397877Cherla A, Kyriopoulos I, Pearcy P, Tsangalidou Z, Hajrulahovic H, Theodorakis P, Andersson CE, Mehra MR, Mossialos E. Trends in avoidable mortality from cardiovascular diseases in the European Union, 1995-2020: a retrospective secondary data analysis. Lancet Reg Health Eur. 2024 Sep 27;47:101079. doi: 10.1016/j.lanepe.2024.101079. eCollection 2024 Dec.
- Background: PubMed 39439212McCarthy CP, Bruno RM, McEvoy JW, Touyz RM. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension: what is new in pharmacotherapy? Eur Heart J Cardiovasc Pharmacother. 2025 Feb 8;11(1):7-9. doi: 10.1093/ehjcvp/pvae084. No abstract available.
- Background: PubMed 36788550Rajput D, Wang WJ, Chen CC. Evaluation of a decided sample size in machine learning applications. BMC Bioinformatics. 2023 Feb 14;24(1):48. doi: 10.1186/s12859-023-05156-9.
- Background: PubMed 37588176Kouz K, Monge Garcia MI, Cerutti E, Lisanti I, Draisci G, Frassanito L, Sander M, Ali Akbari A, Frey UH, Grundmann CD, Davies SJ, Donati A, Ripolles-Melchor J, Garcia-Lopez D, Vojnar B, Gayat E, Noll E, Bramlage P, Saugel B. Intraoperative hypotension when using hypotension prediction index software during major noncardiac surgery: a European multicentre prospective observational registry (EU HYPROTECT). BJA Open. 2023 May 4;6:100140. doi: 10.1016/j.bjao.2023.100140. eCollection 2023 Jun.
- Background: PubMed 39041366Lopez-Lopez JP, Garcia-Pena AA, Martinez-Bello D, Gonzalez AM, Perez-Mayorga M, Munoz Velandia OM, Ruiz-Uribe G, Campo A, Rangarajan S, Yusuf S, Lopez-Jaramillo P. External validation and comparison of six cardiovascular risk prediction models in the Prospective Urban Rural Epidemiology (PURE)-Colombia study. Eur J Prev Cardiol. 2025 May 12;32(7):564-572. doi: 10.1093/eurjpc/zwae242.
- Background: PubMed 37247330SCORE2-Diabetes Working Group and the ESC Cardiovascular Risk Collaboration. SCORE2-Diabetes: 10-year cardiovascular risk estimation in type 2 diabetes in Europe. Eur Heart J. 2023 Jul 21;44(28):2544-2556. doi: 10.1093/eurheartj/ehad260.
- Background: PubMed 36979665Goldenholz DM, Sun H, Ganglberger W, Westover MB. Sample Size Analysis for Machine Learning Clinical Validation Studies. Biomedicines. 2023 Feb 23;11(3):685. doi: 10.3390/biomedicines11030685.
- Background: PubMed 35239404Powell-Wiley TM, Baumer Y, Baah FO, Baez AS, Farmer N, Mahlobo CT, Pita MA, Potharaju KA, Tamura K, Wallen GR. Social Determinants of Cardiovascular Disease. Circ Res. 2022 Mar 4;130(5):782-799. doi: 10.1161/CIRCRESAHA.121.319811. Epub 2022 Mar 3.
- CARAMEL project website, which provides general information, updates on the project's development, non-confidential results, information about the consortium members, among other relevant content.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Clinical Efficacy of Thumbtack Needle for Chronic Insomnia in Perimenopausal and Menopausal Women
Chronic Insomnia During Perimenopause and Menopause
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
Recruiting
Nutritional Supplementation on Physiological and Metabolic Markers in Females
Perimenopausal Women, Body Composition Changes
Recruiting
Exercise in Perimenopause to Improve Cognitive Health
Perimenopause, Subjective Cognitive Complaints
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perimenopause and Menopause, run by Biogipuzkoa Health Research Institute at 6 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain, Colombia, Croatia, Greece, Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Primary Care - OSIs Research Unit ((+34)943006086, unidadinvestigaciongip@osakidetza.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypertension (time frame: From enrollment to program completion, spanning 21-24 months depending on the enrollment date.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07695376, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.