Study Protocol: 10-Year Follow-Up of Patients Screened for Cardiovascular Risk by the "All With Heart" Association - Development of a Morocco-Specific Risk Score

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases (CVD)

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Mohamed ALAMI
• Study Contact Backup: Name: Najat MOUINE, Professor of Cardiology; Phone Number: +212661202733; Email: mouine2@yahoo.fr

Study Locations

• Morocco
  • Casablanca, Morocco, 20200
    • Recruiting
    • Moroccan Society of Cardiology
    • Contact: Mohamed ALAMI, Professor of Cardiology; Phone Number: +212661157806; Email: cabinetalami@gmail.com
  • Rabat, Morocco
    • Recruiting
    • Cardiology Centre, Mohammed V Military Hospital, Rabat, Morocco
    • Contact: Najat MOUINE, Professor of Cardiology; Phone Number: +212661202733; Email: mouine2@yahoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes adults aged 40 years and older who were screened for cardiovascular risk between 2010 and 2012 by the "All with heart" Association in the Greater Casablanca region, Morocco. Approximately 10,000 individuals participated in the original screening campaign, which collected data on anthropometric, biological, and lifestyle risk factors.

For the 10-year follow-up, all eligible Moroccan participants from the initial screening will be contacted by phone, WhatsApp, or SMS to collect updated information on cardiovascular events, hospitalizations, and mortality. This population represents a community-based cohort reflecting the general adult population at risk of cardiovascular disease in Morocco.

Description

Inclusion Criteria:

• Adults aged 40 years or older at the time of the initial screening (2010-2012).
• Individuals who participated in the cardiovascular risk screening campaign conducted by the "All with heart" Association between 2010 and 2012 in the Greater Casablanca region.
• Moroccan nationality.
• Participants or family members who provide written informed consent for participation in the 10-year follow-up study.

Exclusion Criteria:

• Individuals who refuse to participate in the follow-up study.
• Participants who have moved and cannot be reached by phone, WhatsApp, or SMS.
• Participants who died from non-cardiovascular causes.
• Non-Moroccan participants.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Participants screened for cardiovascular risk (TAC cohort); Participants aged 40 years and older who were screened for cardiovascular risk between 2010 and 2012 by the "All with heart" Association in the Greater Casablanca region. This cohort is being followed 10 years after the initial screening to assess cardiovascular outcomes (death, myocardial infarction, stroke) and to develop a Morocco-specific cardiovascular risk score. No intervention is applied; the study is purely observational.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Major Cardiovascular Events (MACE)	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.	10 years after initial screening (2010-2012)
Development and Validation of a Morocco-Specific Cardiovascular Risk Score	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.	Baseline (2010-2012) and 10-year follow-up (2022)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Minor Cardiovascular Events	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.	10 years after initial screening (2010-2012)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Hospitalizations Related to Cardiovascular Diseases	Total number of hospitalizations due to cardiovascular causes (acute coronary syndrome, heart failure, arrhythmia, or cardiac surgery) during the 10-year follow-up period.	10 years after initial screening (2010-2012)
Change in Cardiovascular Risk Factors Over Time	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.	10 years after initial screening (2010-2012)
Quality of Life Assessment	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.	10 years after initial screening (2010-2012)

Collaborators and Investigators

• Sponsor: Moroccan Society of Cardiology
• Collaborators: F&C Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 126/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

The sharing of individual participant data (IPD) is not authorized by the Ethics Committee of Rabat.

According to the committee's decision, data collected in this study are strictly confidential and may only be used by the research team for the purposes defined in the approved protocol. All collected data will remain stored securely and will not be shared with other researchers or institutions to ensure compliance with national data protection regulations and the ethical approval obtained for this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No