Stress Reactivity and Mother-Infant Cardiovascular Disease Risk
NCT06805799
Behavioral Medicine, Cardiovascular Diseases
Providence, Rhode Island, United States
View Trial DetailsNCT Number: NCT06674161
Cardiovascular disease (CVD) and Type 2 diabetes mellitus (T2DM) are major global health challenges with significant morbidity and mortality. In Saudi Arabia, the prevalence of CVD and T2DM is increasing. This poses a significant burden on the healthcare system. Despite extensive global research, there remains a lack of comprehensive studies examining the combined impact of CVD and T2DM in the Saudi population, particularly in the Western region. Objectives: The primary objectives of the study are: (1) quantify the incidence and mortality rates of CVD and T2DM across various demographics in the Western region of Saudi Arabia; (2) analyse the demographic, clinical, and lifestyle factors contributing to cardiovascular risk in individuals with both conditions; (3) understand the influence of cultural, social, and religious beliefs on health behaviours related to CVD and T2DM using social media and survey data; (4) develop a predictive model for forecasting future cardiovascular events in the Saudi population; and (5) evaluate the impact of the ICD11 classification of CVD. Methodology: The project will include team of experts from King Faisal Specialist Hospital and Research Centre, Madinah, Taibah University, Islamic University of Madinah, University of Prince Mugrin, and King's College University, London. We will work under four workstreams (WS) which are: WS 1: This group will supervise the data collection, analysis and ensure efficient running of the project. WS 2: In year 1, retrospective data will be collected on the service needs, long term outcomes, and mortality of patients with CVD and T2DM, CVD only, T2DM only, and neither. Between Year 1 to 5, we will collect data prospectively using the new ICD-11 criteria. Both, retrospective and prospective data will be used to develop an artificial intelligence (AI) based predictive model. WS 3: Social media survey will be undertaken to understand health beliefs and behaviours influencing health related outcome to CVD and T2DM. WS 4: Undertake economic analyses into long-term resource utilisation and cost of care for CVD and T2DM.
Expected Outcomes:
The study is expected to provide a detailed incidence and all-cause mortality CVD and T2DM in the Western region of Saudi Arabia. This will help in identifying risk factors and predictive for CVD and understand health beliefs and behaviours in Saudi Arabia. The data will help in developing policies, guidelines and awareness programmes in collaboration with policy makers. In conclusion, this study will impact by improving epidemiological knowledge and understanding of CVD and T2DM in Saudi Arabia. The project will support the overall mission of Saudi Vision 2030 with regard to increasing the health and well-being of the population.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Innoviation:
The proposed study will introduce a novel theoretical framework and methodology for comprehensive investigation of the interrelationship between the various combinations of CVD and T2DM within Saudi Arabia.
Key features of the innovative theoretical concept include:
Key innovative methodologies and approaches include:
Methodology:
Aims and objectives We aim to improve the lives of people with CVD, T2DM and other risk factors through innovative data collection, use of data, and design personalised and optimised management strategies. We will accomplish this by creating four workstreams (WS), which will run in parallel and work collaboratively throughout the programme.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All adult patients with available records in the western region of Saudi Arabia
Exclusion criteria
age below 18 years
Time frame: 12 months
Quantify the incidence, trends, and mortality rates of CVD and T2DM across different regions and demographics in the western region of Saudi Arabia,
Time frame: 24 months
Time frame: 36 Months
Develop a predictive model to forecast future CVD events across various combinations of CVD and T2DM. This will provide early individualized management to improve secondary prevention. The data from this modelling work will provide key insights to support self-management via an already existing electronic patient portal.
Contact information is provided by the study sponsor or research team.
King Faisal Specialist Hospital & Research Center
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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.
Published trials that share one or more normalized conditions with this study.
NCT06805799
Behavioral Medicine, Cardiovascular Diseases
Providence, Rhode Island, United States
View Trial DetailsNCT07727135
Acute Coronary Syndrome, Angina Pectoris
Aalborg, Denmark
View Trial DetailsNCT07721584
Arterial Occlusive Diseases, Arteriosclerosis
View Trial DetailsNCT07721649
Acute Coronary Syndrome, Behavior
Cologne, Germany
View Trial Details