Mortality of Patients with CVDNCT06674161
The Impact of Type 2 Diabetes Mellitus on Cardiovascular Events in Saudi Arabia Now and Future
An observational study of Mortality of Patients with CVD and Mortality of Patients with CVD and T2DM, run by King Faisal Specialist Hospital & Research Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mortality of Patients with CVD, Mortality of Patients with CVD and T2DM, Mortality of Patients with T2DM
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2024to 31 Dec 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients in the western region of Saudi Arabia
Who may be able to join
- All adult patients with available records in the western region of Saudi Arabia
Who cannot join
- age below 18 years
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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:
- Population specific focus: Our research will be focused on the population of Saudi Arabia based demographic, cultural and environmental factors influencing the incidence and outcomes of CVD and T2DM.
- Health belief: Our study will investigate health beliefs and behaviour related to CVD and T2DM. This would involve using artificial intelligence data analytic per direct questionnaires, published literature, and social media.
- Predictive modelling: We aim to conduct a predictive modelling and develop a functional model that predicts future CVE and diabetes related cardiovascular complications.
Key innovative methodologies and approaches include:
- Retrospective population-based study: A large population-based retrospective study will be conducted to determine the incidence and mortality of CVD with and without T2DM. This methodology will thus provide robust epidemiological data by adjusting for possible confounders using Cox regression models in determining hazard ratios.
- Combination of CVD with/without T2DM: The results will be compared across the four groups: individuals with no CVD and T2DM, CVD only, T2DM only, and both conditions.
- Risk factor insight: Understanding the risk factors concerning CVD and T2DM in Saudi Arabia.
- Using AI to evaluate health belief: Conducting large scale survey on health belief using AI to analyse data obtained from existing literature, digital resources, social media platforms, and direct questionnaires.
- Development of predictive model for future CV events: This model will be based on detailed analysis and interpretation of collected data. This will facilitate the forecasting of disease patterns and guiding preventive approaches.
- Collaborative approach: The project involves a collaborative effort by 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. This multidisciplinary approach ensures a comprehensive analysis that utilises diverse expertise
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.
- Workstream 1 (WS1): We will engage with those who have suffered from CVD. They will grouped into three main groups: those with Stroke, IHD and other CVD. The three groups will be subdivided into two subcategories: those with and without T2DM. This group will have individuals who are survivors of this disease, carers, public health experts, clinicians and policymakers. This group will shape the data collection, analysis and use of the data.
- Workstream 2 (WS2): We will work towards estimating the impact of the WHO ICD11 definition of stroke, atherosclerotic CAD and T2DM. The group will also try to understand the long-term outcome and care needs of CVD survivors both individually and as a population.
- Workstream 3 (WS3): We will use social media, community forums and healthcare facilities to understand the health beliefs of the individual and population groups. We will try to understand the effect on the health outcome of the individual and the population of these health beliefs.
- Workstream 4 (WS4): This stream will estimate the economic impact of care, service models, and options with the aim of improving decision-making for policymakers, survivors, and individuals at higher risk, as well as their families.
- Conditions
- Mortality of Patients with CVD, Mortality of Patients with CVD and T2DM, Mortality of Patients with T2DM, Mortality of Patients with Neither, Morbidity of CVD, Cardiovascular Diseases
- Keywords
- CVD, T2DM, mortality, morbidity, CVD risk
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CVD with type 2 diabetes | Not described | |
| CVD without type 2 diabetes | Not described | |
| T2DM only without CVD | Not described | |
| No T2DM and no CVD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study
Quantify the incidence, trends, and mortality rates of CVD and T2DM across different regions and demographics in the western region of Saudi Arabia,
Measured: 12 months
Secondary outcomes (1)
Risk Factors Evaluation
- Analyse various demographic, clinical, and lifestyle factors contributing to cardiovascular risk in individuals with CVD and T2DM to indicate inequalities among different phenotypes and identify critical risk factors for targeted prevention and management.
- Understand cultural, social, and religious factors that influence health beliefs and perceptions related to CVD and T2DM using data from social media in Saudi Arabia. This will facilitate the design of culturally appropriate health interventions.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start30 Nov 2024 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Mortality of Patients with CVDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahad Ahmed Wali, King Faisal Specialist Hospital & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674161
- Sponsor's protocol ID
- RAC/M 2024-31
- Status last verified
- Oct 2024
- First submitted
- 2 Nov 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Teare MD, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters SJ. Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials. 2014 Jul 3;15:264. doi: 10.1186/1745-6215-15-264.
PubMed 24993581Al-Jedai A, Almudaiheem H, Al-Salamah T, Aldosari M, Almutairi AR, Almogbel Y, AlRuthia Y, Althemery AU, Alluhidan M, Roudijk B, Purba FD, Awad N, O'jeil R. Valuation of EQ-5D-5L in the Kingdom of Saudi Arabia: A National Representative Study. Value Health. 2024 May;27(5):552-561. doi: 10.1016/j.jval.2024.01.017. Epub 2024 Feb 9.
PubMed 38342365Jatoi NA, Elamin YA, Said AH, Al-Namer B, Al-Muallim FA, Al-Nemer FF, Al-Halal FM. Prevalence of Cardiovascular Risk Factors Among Patients With Diabetes Mellitus Type 2 at King Fahad University Hospital, Saudi Arabia. Cureus. 2022 Sep 23;14(9):e29489. doi: 10.7759/cureus.29489. eCollection 2022 Sep.
PubMed 36299951Al-Daghri NM, Al-Attas OS, Alokail MS, Alkharfy KM, Yousef M, Sabico SL, Chrousos GP. Diabetes mellitus type 2 and other chronic non-communicable diseases in the central region, Saudi Arabia (Riyadh cohort 2): a decade of an epidemic. BMC Med. 2011 Jun 20;9:76. doi: 10.1186/1741-7015-9-76.
PubMed 21689399Assiri AA, Alahmari KA, Alqhtani NS, AlShamrani NA, Mubarak AS, Alshehri KM, Alselmi AA. Prevalence of cardiovascular events among patients with type 2 diabetes in the west region of Saudi Arabia. Saudi Pharm J. 2022 Dec;30(12):1825-1829. doi: 10.1016/j.jsps.2022.10.012. Epub 2022 Nov 3.
PubMed 36601500Alshamiri M, Ghanaim MMA, Barter P, Chang KC, Li JJ, Matawaran BJ, Santoso A, Shaheen S, Suastika K, Thongtang N, Yusof AK. Expert opinion on the applicability of dyslipidemia guidelines in Asia and the Middle East. Int J Gen Med. 2018 Jul 18;11:313-322. doi: 10.2147/IJGM.S160555. eCollection 2018.
PubMed 30050317Cheng YJ, Imperatore G, Geiss LS, Saydah SH, Albright AL, Ali MK, Gregg EW. Trends and Disparities in Cardiovascular Mortality Among U.S. Adults With and Without Self-Reported Diabetes, 1988-2015. Diabetes Care. 2018 Nov;41(11):2306-2315. doi: 10.2337/dc18-0831. Epub 2018 Aug 21.
PubMed 30131397Yun JS, Ko SH. Current trends in epidemiology of cardiovascular disease and cardiovascular risk management in type 2 diabetes. Metabolism. 2021 Oct;123:154838. doi: 10.1016/j.metabol.2021.154838. Epub 2021 Jul 30.
PubMed 34333002Chow CK, Islam S, Bautista L, Rumboldt Z, Yusufali A, Xie C, Anand SS, Engert JC, Rangarajan S, Yusuf S. Parental history and myocardial infarction risk across the world: the INTERHEART Study. J Am Coll Cardiol. 2011 Feb 1;57(5):619-27. doi: 10.1016/j.jacc.2010.07.054. No abstract available.
PubMed 21272754Lloyd-Jones DM, Nam BH, D'Agostino RB Sr, Levy D, Murabito JM, Wang TJ, Wilson PW, O'Donnell CJ. Parental cardiovascular disease as a risk factor for cardiovascular disease in middle-aged adults: a prospective study of parents and offspring. JAMA. 2004 May 12;291(18):2204-11. doi: 10.1001/jama.291.18.2204.
PubMed 15138242D'Agostino RB Sr, Vasan RS, Pencina MJ, Wolf PA, Cobain M, Massaro JM, Kannel WB. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 2008 Feb 12;117(6):743-53. doi: 10.1161/CIRCULATIONAHA.107.699579. Epub 2008 Jan 22.
PubMed 18212285Savji N, Rockman CB, Skolnick AH, Guo Y, Adelman MA, Riles T, Berger JS. Association between advanced age and vascular disease in different arterial territories: a population database of over 3.6 million subjects. J Am Coll Cardiol. 2013 Apr 23;61(16):1736-43. doi: 10.1016/j.jacc.2013.01.054. Epub 2013 Apr 2.
PubMed 23500290Asia Pacific Cohort Studies Collaboration. Joint effects of systolic blood pressure and serum cholesterol on cardiovascular disease in the Asia Pacific region. Circulation. 2005 Nov 29;112(22):3384-90. doi: 10.1161/CIRCULATIONAHA.105.537472. Epub 2005 Nov 21.
PubMed 16301345Lowe LP, Greenland P, Ruth KJ, Dyer AR, Stamler R, Stamler J. Impact of major cardiovascular disease risk factors, particularly in combination, on 22-year mortality in women and men. Arch Intern Med. 1998 Oct 12;158(18):2007-14. doi: 10.1001/archinte.158.18.2007.
PubMed 9778200Global Cardiovascular Risk Consortium; Magnussen C, Ojeda FM, Leong DP, Alegre-Diaz J, Amouyel P, Aviles-Santa L, De Bacquer D, Ballantyne CM, Bernabe-Ortiz A, Bobak M, Brenner H, Carrillo-Larco RM, de Lemos J, Dobson A, Dorr M, Donfrancesco C, Drygas W, Dullaart RP, Engstrom G, Ferrario MM, Ferrieres J, de Gaetano G, Goldbourt U, Gonzalez C, Grassi G, Hodge AM, Hveem K, Iacoviello L, Ikram MK, Irazola V, Jobe M, Jousilahti P, Kaleebu P, Kavousi M, Kee F, Khalili D, Koenig W, Kontsevaya A, Kuulasmaa K, Lackner KJ, Leistner DM, Lind L, Linneberg A, Lorenz T, Lyngbakken MN, Malekzadeh R, Malyutina S, Mathiesen EB, Melander O, Metspalu A, Miranda JJ, Moitry M, Mugisha J, Nalini M, Nambi V, Ninomiya T, Oppermann K, d'Orsi E, Pajak A, Palmieri L, Panagiotakos D, Perianayagam A, Peters A, Poustchi H, Prentice AM, Prescott E, Riserus U, Salomaa V, Sans S, Sakata S, Schottker B, Schutte AE, Sepanlou SG, Sharma SK, Shaw JE, Simons LA, Soderberg S, Tamosiunas A, Thorand B, Tunstall-Pedoe H, Twerenbold R, Vanuzzo D, Veronesi G, Waibel J, Wannamethee SG, Watanabe M, Wild PS, Yao Y, Zeng Y, Ziegler A, Blankenberg S. Global Effect of Modifiable Risk Factors on Cardiovascular Disease and Mortality. N Engl J Med. 2023 Oct 5;389(14):1273-1285. doi: 10.1056/NEJMoa2206916. Epub 2023 Aug 26.
PubMed 37632466