Cardiovascular Risk Factors in Mexican Women
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMedicaweb, S.A.C.V.
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
3,000 Participants
are grouped into 2 trial groupsGroup A: Women Without Previous Cardiovascular Events
Group B: Women With Previous Cardiovascular Events
Trial outcomes
Primary outcomes
1
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.
Time frame
At the time of enrollment2
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.
Time frame
At the time of enrollment3
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.
Time frame
At the time of enrollment4
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.
Time frame
At the time of enrollmentSecondary outcomes
1
Prevalence of Depressive Symptoms
Prevalence of depressive symptoms among participating women, assessed using the Patient Health Questionnaire-2 (PHQ-2).
Time frame
At the time of enrolment2
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.
Time frame
At the time of enrollment3
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.
Time frame
At the time of enrollment4
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.
Time frame
At the time of enrollmentSponsors and contacts
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Source ClinicalTrials.gov
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