Ireland
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Starting soon Observational

Cardiovascular Risk Factors in Mexican Women

NCT07863674 · tracked via the Priya Life Science Mexico tracker
Sponsor
Medicaweb, S.A.C.V
Phase
Observational
Started
2026-11
Last updated
2026-10-08

Condition(s) studied

Cardiovascular Risk FactorsCardiovascular Diseases

Study 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. 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Prevalence and Distribution of Cardiovascular Risk Factors — 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 — 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 — 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 — 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.

Trial sites (3)

FacilityCityRegionStatus
UMAE Hospital de Cardiología, Centro Médico Nacional Siglo XXI Mexico City Mexico City
UMAE Hospital de Cardiología No. 34 "Dr. Alfonso J. Treviño Treviño" Centro Médico Nacional del Noroeste. Monterrey Nuevo León
UMAE Hospital de Especialidades No. 14, Centro Médico Nacional "Adolfo Ruiz Cortines" Veracruz Veracruz
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07863674 on ClinicalTrials.gov ↗ ← All trials in Mexico