Prebiotic Inulin for Late-Reproductive Individuals
NCT07724522
Body Weight, Cardiovascular Diseases
Washington D.C., District of Columbia, United States
View Trial DetailsNCT Number: NCT07294937
Cardiovascular diseases (CVDs) are the leading cause of death worldwide, and their prevalence is steadily increasing in Morocco. Between 2010 and 2012, the "All with heart" Association conducted a large-scale cardiovascular screening campaign in the Greater Casablanca region, involving more than 10,000 adults aged over 40 years. This 10-year follow-up study aims to evaluate long-term cardiovascular outcomes and to develop a Morocco-specific cardiovascular risk score. Follow-up data will be collected through phone calls, WhatsApp, or SMS with participants or their families to document cardiovascular deaths, myocardial infarctions, and strokes. Statistical analyses, including survival analysis and multivariate logistic regression, will be used to identify significant risk factors and to construct a predictive risk model tailored to the Moroccan population. The study received a favorable opinion from the Rabat Ethics Committee. Written informed consent will be obtained from all participants or their families prior to data collection. The findings are expected to enhance understanding of cardiovascular risk evolution in Morocco and to provide a validated, population-specific risk score to support prevention and patient management strategies.
Interested in participating?
Request Info40 year and older
All sexes
Observational
Moroccan Society of Cardiology, Casablanca, Morocco
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 10 years after initial screening (2010-2012)
Occurrence of major cardiovascular events (myocardial infarction, stroke, or cardiovascular death) among participants screened for cardiovascular risk between 2010 and 2012 by the "All with heart" Association. Events will be identified during the 10-year follow-up period through participant or family contact (phone, WhatsApp, or SMS) and verified through available medical records when possible.
Time frame: Baseline (2010-2012) and 10-year follow-up (2022)
Development and internal validation of the Morocco-Specific Cardiovascular Risk Score, a composite risk prediction score estimating the 10-year probability of major cardiovascular events including myocardial infarction, stroke, or cardiovascular death. The score will be derived from baseline cardiovascular risk factors collected during the initial screening and weighted using multivariable regression models based on outcomes observed during the 10-year follow-up. The score will be expressed on a scale ranging from 0 to 100, where higher scores indicate a higher cardiovascular risk and therefore a worse outcome. Model performance will be assessed using discrimination and calibration measures, including the area under the receiver operating characteristic curve and calibration analyses.
Time frame: 10 years after initial screening (2010-2012)
Occurrence of minor cardiovascular events, including stable or unstable angina, among participants screened between 2010 and 2012. Events will be collected through participant or family interviews and verified with medical records when available.
Time frame: 10 years after initial screening (2010-2012)
Total number of hospitalizations due to cardiovascular causes (acute coronary syndrome, heart failure, arrhythmia, or cardiac surgery) during the 10-year follow-up period.
Time frame: 10 years after initial screening (2010-2012)
Change in major cardiovascular risk factors (body mass index, blood pressure, total cholesterol, triglycerides, HDL, blood glucose, smoking status, and physical activity) between the initial screening and the 10-year follow-up.
Time frame: 10 years after initial screening (2010-2012)
Evaluation of participants' quality of life using a standardized questionnaire (EQ-5D). The assessment will explore mobility, self-care, usual activities, pain/discomfort, and anxiety/depression dimensions.
Contact information is provided by the study sponsor or research team.
Moroccan Society of Cardiology
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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