Cardiovascular Risk FactorsREFARCAM MxNCT07863674
Cardiovascular Risk Factors in Mexican Women
An observational study of Cardiovascular Risk Factors and Cardiovascular Diseases, run by Medicaweb, S.A.C.V. at 3 sites in Mexico.
Trial summary
Cardiovascular disease is a major cause of morbidity and mortality among women. Cardiovascular risk in women is influenced not only by traditional risk factors, but also by sex-specific factors and social determinants of health. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors, Cardiovascular Diseases
- How many people
- 3,000 participants
- Where
- 3 sitesMexico
- Study dates
- Nov 2026to Dec 2027
- How long will I take part?
- 1 Day
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult female IMSS beneficiaries receiving medical care at 36 participating IMSS medical units representing the three levels of healthcare in Mexico. Participants will be selected from women attending the participating medical units during the recruitment period.
Who may be able to join
- Female participants aged 18 years or older.
- Receiving medical care at one of the participating IMSS medical units.
- Available clinical medical record.
- Pathological and non-pathological medical history information available as required by the study data collection form.
- Able and willing to provide written informed consent.
Who cannot join
- Clinical medical record lost or inaccessible for study purposes.
- Conditions that limit the participant's ability to respond during the evaluation, including dementia, stroke with cognitive impairment, or ongoing orotracheal intubation.
- Withdrawal of consent after initiation of the interview or unwillingness to provide the information required for the study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico3 sites
UMAE Hospital de Cardiología, Centro Médico Nacional Siglo XXI
Mexico City, Mexico City, 06725
Rosalba Carolina García Méndez, MD, +52 5554070292, rosalba.garciam@imss.gob.mx
Rosalba Carolina García Méndez, MD
UMAE Hospital de Cardiología No. 34 "Dr. Alfonso J. Treviño Treviño" Centro Médico Nacional del Noroeste.
Monterrey, Nuevo León, 64360
Denisse Guzmán Ramírez, MD, +52 8110409545, draguzman@cardiologiamonterrey.com.mx
Denise Guzmán Ramírez, MD
UMAE Hospital de Especialidades No. 14, Centro Médico Nacional "Adolfo Ruiz Cortines"
Veracruz, Veracruz, 91810
Yoloxóchitl García Jiménez, MD, +52 2292641800, yoloxochitl.garcia.j@gmail.com
Yoloxóchitl García Jiménez, MD
About this study
Official title: Registry of Cardiovascular Risk Factors in Mexican Women (REFARCAM Mx)
Cardiovascular disease is a major cause of morbidity and mortality among women. Cardiovascular risk in women is influenced not only by traditional risk factors, but also by sex-specific factors and social determinants of health. However, information on the distribution and relative importance of these factors among Mexican women remains limited.
REFARCAM Mx is a multicenter, observational, cross-sectional registry designed to estimate the prevalence and describe the distribution of traditional, sex-specific, and emerging cardiovascular risk factors, as well as social determinants of health, among adult female beneficiaries of the Mexican Social Security Institute (IMSS) receiving care at participating medical units in Mexico.
Read more
Approximately 3,000 women aged 18 years or older will be enrolled across 36 IMSS medical units representing the three levels of healthcare. Participants will complete the validated REFARCAM Mx questionnaire administered by trained personnel using a secure digital platform. Clinical and anthropometric information, including blood pressure, weight, height, and heart rate, will also be collected, and available clinical information will be verified using the institutional medical record. In women aged 40 to 74 years, cardiovascular risk will be estimated using the HEARTS for the Americas cardiovascular risk calculator.
The collected information will be used to characterize cardiovascular risk in women receiving care at participating IMSS centers and to explore factors associated with previous cardiovascular events. Statistical analyses will include conventional multivariable methods and machine-learning approaches to identify relevant patterns and predictors of cardiovascular risk.
- Keywords
- Women, Cardiovascular Risk, Cardiovascular Risk Factors, Sex-Specific Risk Factors, Women's Cardiovascular Health, Social Determinants of Health, Cardiovascular Disease Prevention, Mexico
- Medical subject headings
- Cardiovascular Diseases
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 |
|---|---|---|
| Women Without Previous Cardiovascular Events | Women without documented history of angina pectoris, acute myocardial infarction, or stroke. | |
| Women With Previous Cardiovascular Events | Women with a documented history of at least one cardiovascular event, including angina pectoris, acute myocardial infarction, or stroke. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and Distribution of Cardiovascular Risk Factors
Prevalence and distribution of traditional cardiovascular risk factors among participating adult women, assessed using the REFARCAM Mx questionnaire, clinical measurements, and available information from the institutional medical record.
Measured: At the time of enrollment
Factors Associated With High Cardiovascular Risk
Factors associated with high cardiovascular risk will be evaluated among women aged 40 to 74 years. Cardiovascular risk will be estimated using the HEARTS for the Americas cardiovascular risk calculator and categorized as low (<5%), moderate (5 to <10%), high (10 to <20%), very high (20 to <30%), or critical (≥30%). Associations between cardiovascular risk factors and high cardiovascular risk will be assessed.
Measured: At the time of enrollment
Prevalence of Sex-Specific Cardiovascular Risk Factors
Prevalence of sex-specific cardiovascular risk factors among participating women and their association with high cardiovascular risk. These factors include reproductive and pregnancy-related conditions and other female-specific cardiovascular risk factors assessed using the REFARCAM Mx questionnaire.
Measured: At the time of enrollment
Prevalence of Social Determinants of Health
Prevalence and distribution of social determinants of health among participating women and their association with high cardiovascular risk, as assessed using the REFARCAM Mx questionnaire.
Measured: At the time of enrollment
Secondary outcomes (5)
Prevalence of Depressive Symptoms
Prevalence of depressive symptoms among participating women, assessed using the Patient Health Questionnaire-2 (PHQ-2).
Measured: At the time of enrolment
Cardiovascular Risk Profile According to History of Cardiovascular Events
Comparison of traditional, sex-specific, and emerging cardiovascular risk factors, as well as social determinants of health, between women with and without a documented history of cardiovascular events, including angina pectoris, acute myocardial infarction, or stroke.
Measured: At the time of enrollment
Factors Independently Associated With Cardiovascular Risk
Independent associations between traditional, sex-specific, and emerging cardiovascular risk factors and social determinants of health with cardiovascular risk will be evaluated using adjusted multivariable statistical models.
Measured: At the time of enrollment
Multivariable Cardiovascular Risk Patterns Identified by Machine Learning.
Exploratory machine-learning models, including Random Forest, XGBoost, and LightGBM, will be used to identify multivariable patterns associated with cardiovascular risk. Model performance will be evaluated using AUC, accuracy, sensitivity, specificity, and F1-score, and variable importance will be interpreted using SHAP.
Measured: At the time of enrollment
Knowledge and Self-Perception of Cardiovascular Risk.
Level of knowledge about cardiovascular disease and self-perception of cardiovascular risk among participating women, assessed using the REFARCAM Mx questionnaire.
Measured: At the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorsStudies 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
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Medicaweb, S.A.C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoloxóchitl García Jiménez, MD, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863674
- Sponsor's protocol ID
- PI-2026-2735
- Other IDs
- R-2026-785-091
- Acronym
- REFARCAM Mx
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not currently planned to be shared outside the authorized research team. Study data will be maintained as a coded dataset with restricted access in accordance with the study protocol, institutional requirements, and applicable data protection and confidentiality regulations.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Cardiovascular Risk Factors in Mexican Women (REFARCAM Mx)
- ClinicalTrials.gov ID
- NCT07863674
- Acronym / sponsor ID
- REFARCAM Mx / PI-2026-2735
- Keywords
- Women, Cardiovascular Risk, Cardiovascular Risk Factors, Sex-Specific Risk Factors, Women's Cardiovascular Health, Social Determinants of Health, Cardiovascular Disease Prevention, Mexico
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Medicaweb, S.A.C.V.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Oct 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.
Cardiovascular disease is a major cause of morbidity and mortality among women. Cardiovascular risk in women is influenced not only by traditional risk factors, but also by sex-specific factors and social determinants of health. However, information on the distribution and relative importance of these factors among Mexican women remains limited.
REFARCAM Mx is a multicenter, observational, cross-sectional registry designed to estimate the prevalence and describe the distribution of traditional, sex-specific, and emerging cardiovascular risk factors, as well as social determinants of health, among adult female beneficiaries of the Mexican Social Security Institute (IMSS) receiving care at participating medical units in Mexico.
Approximately 3,000 women aged 18 years or older will be enrolled across 36 IMSS medical units representing the three levels of healthcare. Participants will complete the validated REFARCAM Mx questionnaire administered by trained personnel using a secure digital platform. Clinical and anthropometric information, including blood pressure, weight, height, and heart rate, will also be collected, and available clinical information will be verified using the institutional medical record. In women aged 40 to 74 years, cardiovascular risk will be estimated using the HEARTS for the Americas cardiovascular risk calculator.
The collected information will be used to characterize cardiovascular risk in women receiving care at participating IMSS centers and to explore factors associated with previous cardiovascular events. Statistical analyses will include conventional multivariable methods and machine-learning approaches to identify relevant patterns and predictors of cardiovascular risk.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women Without Previous Cardiovascular Events | – | –Women without documented history of angina pectoris, acute myocardial infarction, or stroke. |
| Women With Previous Cardiovascular Events | – | –Women with a documented history of at least one cardiovascular event, including angina pectoris, acute myocardial infarction, or stroke. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female IMSS beneficiaries receiving medical care at 36 participating IMSS medical units representing the three levels of healthcare in Mexico. Participants will be selected from women attending the participating medical units during the recruitment period.
Key inclusion criteria (5 listed)
- Female participants aged 18 years or older.
- Receiving medical care at one of the participating IMSS medical units.
- Available clinical medical record.
- Pathological and non-pathological medical history information available as required by the study data collection form.
- Able and willing to provide written informed consent.
Key exclusion criteria (3 listed)
- Clinical medical record lost or inaccessible for study purposes.
- Conditions that limit the participant's ability to respond during the evaluation, including dementia, stroke with cognitive impairment, or ongoing orotracheal intubation.
- Withdrawal of consent after initiation of the interview or unwillingness to provide the information required for the study.
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
Prevalence and Distribution of Cardiovascular Risk Factors
Time frame: At the time of enrollment
Prevalence and distribution of traditional cardiovascular risk factors among participating adult women, assessed using the REFARCAM Mx questionnaire, clinical measurements, and available information from the institutional medical record.
Factors Associated With High Cardiovascular Risk
Time frame: At the time of enrollment
Factors associated with high cardiovascular risk will be evaluated among women aged 40 to 74 years. Cardiovascular risk will be estimated using the HEARTS for the Americas cardiovascular risk calculator and categorized as low (<5%), moderate (5 to <10%), high (10 to <20%), very high (20 to <30%), or critical (≥30%). Associations between cardiovascular risk factors and high cardiovascular risk will be assessed.
Prevalence of Sex-Specific Cardiovascular Risk Factors
Time frame: At the time of enrollment
Prevalence of sex-specific cardiovascular risk factors among participating women and their association with high cardiovascular risk. These factors include reproductive and pregnancy-related conditions and other female-specific cardiovascular risk factors assessed using the REFARCAM Mx questionnaire.
Prevalence of Social Determinants of Health
Time frame: At the time of enrollment
Prevalence and distribution of social determinants of health among participating women and their association with high cardiovascular risk, as assessed using the REFARCAM Mx questionnaire.
5 secondary outcomes
Prevalence of Depressive Symptoms
Time frame: At the time of enrolment
Cardiovascular Risk Profile According to History of Cardiovascular Events
Time frame: At the time of enrollment
Factors Independently Associated With Cardiovascular Risk
Time frame: At the time of enrollment
Multivariable Cardiovascular Risk Patterns Identified by Machine Learning.
Time frame: At the time of enrollment
Knowledge and Self-Perception of Cardiovascular Risk.
Time frame: At the time of enrollment
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 8 Oct 2026.
- REFARCAM Mx study website and electronic data collection platform.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data are not currently planned to be shared outside the authorized research team. Study data will be maintained as a coded dataset with restricted access in accordance with the study protocol, institutional requirements, and applicable data protection and confidentiality regulations.
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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.
Yoloxóchitl García Jiménez, MD principal investigator
Instituto Mexicano del Seguro Social
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Risk Factors and Cardiovascular Diseases, run by Medicaweb, S.A.C.V. at 3 sites in Mexico.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mexico. 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 Yoloxóchitl García Jiménez, MD (+52 229 264 1800, yoloxochitl.garcia.j@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and Distribution of Cardiovascular Risk Factors (time frame: At the time of enrollment). 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?
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 8 Oct 2026.