Cardiovascular DiseasesPURENCT03225586
Prospective Urban Rural Epidemiology Study
An observational study of Cardiovascular Diseases and Risk Factor, Cardiovascular, run by Population Health Research Institute at 34 sites in 25 countries.
Trial summary
To examine the impact of health determinants at the individual (e.g. health related behaviors) and societal level (e.g. environmental factors, health related policy, quality of health systems) on health outcomes (e.g. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Cardiovascular Diseases, Risk Factor, Cardiovascular, Health Behavior
- How many people
- 200,000 participants
- Where
- 34 sitesin 25 countries
- Study dates
- 1 Jan 2002to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 35 to 70 years
- All sexes
- Adult, Older adult
Study population: Adults aged 35 to 70 years from communities in low-, middle-, and high-income regions of the world representing various levels of development and encompassing great sociocultural diversity.
Who may be able to join
- consenting adults between 35-70 years of age
Who cannot join
- none
Trial locations and contacts
34 sites in 25 countries. Contact the study team or a site near you to ask about taking part.
34 sites in 25 countries
India5 sites, 5 recruiting
- Recruiting
St John's Research Institute
Bangalore, Karnataka
Prem K Mony, MD, MSc, premkmony@gmail.com
- Recruiting
Post Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh
Rajesh Kumar, MD, dr.rajeshkumar@gmail.com
- Recruiting
Madras Diabetes Research Foundation
Chennai, Tamil Nadu
V Mohan, MD, drmohans@diabetes.ind.in
- Recruiting
Eternal Heart Care Centre and Research Institute
Jaipur, Rajasthan
Rajeev Gupta, MD, PhD, rajeevgg@gmail.com
- Recruiting
Health Action by People
Thiruvananthapuram, Kerala
Raman Kutty, MD, MPH, kuttyr@gmail.com
Canada4 sites, 4 recruiting
- Recruiting
Population Health Research Institute
Hamilton, Ontario, L8L2X2
Sandy Trottier, 905-521-2100 ext. 40456, sandy.trottier@phri.ca
Koon Teo, MB, PhD
- Recruiting
University of Ottawa
Ottawa, Ontario, K1H8L6
Andreas Wielgosz, MD, PhD, wielgosz@uottawa.ca
- Recruiting
Université Laval Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec
Gilles Dagenais, MD, Gilles.Dagenais@criucpq.ulaval.ca
- Recruiting
Simon Fraser University
Vancouver, British Columbia
Scott Lear, PhD, SLear@providencehealth.bc.ca
Malaysia2 sites, 2 recruiting
- Recruiting
Universiti Teknologi MARA, UCSI Universiti
Kuala Lumpur
Khalid Yusoff, MBBS, kyusoff@gmail.com
- Recruiting
University Kebangsaan Malaysia
Kuala Lumpur
Noorhassim Ismail, MD, ramalbaru@gmail.com
South Africa2 sites, 2 recruiting
- Recruiting
School of Public Health, University of the Western Cape
Bellville
Thandi Puoane, MPH, Dr PH, tpuoane@uwc.ac.za
- Recruiting
North-West University
Potchefstroom
Lanthe Kruger, PhD, lanthe.kruger@nwu.ac.za
Argentina1 site, 1 recruiting
- Recruiting
Estudios Clinicos Latinoamerica ECLA
Rosario, Santa Fe Province
Rafael Diaz, MD, rdiazmd@eclainternational.org
Bangladesh1 site, 1 recruiting
- Recruiting
Independent University, Bangladesh
Dhaka
Omar Rahman, MD, MPH, DSc, orahman@iub.edu.bd
Rita Yusuf, PhD, ritayusuf@iub.edu.bd
Brazil1 site, 1 recruiting
- Recruiting
Dante Pazzanese Institute of Cardiology
São Paulo
Alvaro Avezum, MD. PhD, avezum@yahoo.com
Chile1 site, 1 recruiting
- Recruiting
Universidad de La Frontera
Temuco
Fernando Lanas, MD, MSc, lanastomas@gmail.com
China1 site, 1 recruiting
- Recruiting
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital
Beijing
Wei Li, PhD, liwei@mrbc-nccd.com
Colombia1 site, 1 recruiting
- Recruiting
Fundacion Oftalmologica de Santander - FOSCAL
Floridablanca, Santander Department
Patricio Lopez-Jaramillo, MD, PhD, jplopezj@gmail.com
Iran1 site, 1 recruiting
- Recruiting
Isfahan University of Medical Sciences
Isfahan
Roya Kelishadi, MD, roya.kelishadi@gmail.com
Kazakhstan1 site, 1 recruiting
- Recruiting
Research Institute of Cardiology & Internal Diseases
Almaty
Kairat Davletov, MD, davletovkairat@gmail.com
Kyrgyzstan1 site, 1 recruiting
- Recruiting
Kyrgyz Society of Cardiology, National Center of Cardiology and Internal Disease
Bishkek
Erkin Mirrakhimov, MD, erkmirr@gmail.com
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University
Karachi
Romaina Iqbal, PhD, romaina.iqbal@aku.edu
Palestinian Territories1 site, 1 recruiting
- Recruiting
Birzeit University, Birzeit
Ramallah
Rasha Khatib, PhD, Rasha.Khatib@phri.ca
Peru1 site, 1 recruiting
- Recruiting
Universidad Peruana Cayetano Heredia
Lima
Jaime Miranda, MD, PhD, jaime.miranda@upch.pe
Philippines1 site, 1 recruiting
- Recruiting
University of Philippines, Section of Adult Medicine & Medical Research Unit
Manila
Antonio L Dans, MD, antoniodans@gmail.com
Poland1 site, 1 recruiting
- Recruiting
Wroclaw Medical University & Department of Internal Medicine
Wroclaw
Andrzej Szuba, MD, PhD, andrzej.szuba@umed.wroc.pl
Russia1 site, 1 recruiting
- Recruiting
Research Institute for Complex Issues of Cardiovascular Diseases
Kemerovo
Olga Barbarash, olb61@mail.ru
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Saud University
Riyadh
Khalid F AlHabib, MBBS, khalidalhabib13@hotmail.com
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital/Östra Hospital
Gothenburg
Annika Rosengren, MD, PhD, annika.rosengren@gu.se
Tanzania1 site, 1 recruiting
- Recruiting
Pamoja Tunaweza Women Center
Moshi
Karen Yeates, MD, yeatesk@queensu.ca
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medeniyet University
Istanbul
Aytekin Oguz, MD, aytekinoguz@hotmail.com
United Arab Emirates1 site, 1 recruiting
- Recruiting
Dubai Medical University
Dubai
Afzalhussein Yusufali, MD, ahYusufali@dha.gov.ae
Zimbabwe1 site, 1 recruiting
- Recruiting
University of Zimbabwe College of Health Sciences
Harare
Jephat Chifamba, DPhil, chifamb@medic.uz.ac.zw
About this study
To examine the impact of health determinants at the individual (e.g. health related behaviors) and societal level (e.g. environmental factors, health related policy, quality of health systems) on health outcomes (e.g. death, non-communicable disease development) across a range of socioeconomic and health resource settings. Additional components of this study will examine genetic factors for non-communicable diseases. This will be examined both through a cross sectional component, and prospectively (cohort component).
Read the detailed description
- To examine the relationship between societal influences and prevalence of risk factors and chronic noncommunicable diseases. Societal determinants are measured by an index of measures from each of the 4 domains of interest: built environment, food and nutrition policy, psychosocial/socioeconomic factors, and tobacco.
- To examine the relationship between societal determinants and incidence of chronic noncommunicable disease events (e.g. cardiovascular disease, cancer) and on changes in rates of selected risk factors (e.g. smoking)
- To examine the relationship between health related behaviors (e.g. diet, physical activity, smoking, alcohol) and health outcomes (e.g. death, non-communicable diseases)
- The quality of health systems across a diverse range of health resource settings, and how this impacts health outcomes
- Genetic factors for non-communicable diseases
- Conditions
- Cardiovascular Diseases, Risk Factor, Cardiovascular, Health Behavior, Environmental Exposure, Lung Diseases, Cancer
- Keywords
- Non-communicable Diseases, Risk Factors
- Medical subject headings
- Cardiovascular Diseases, Health Behavior, Lung Diseases, Neoplasms, Wounds and Injuries, Kidney Diseases, Communicable Diseases, Noncommunicable 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 |
|---|---|---|
| Adults | Between 35 to 70 years of age at time of enrollment |
What is being measured
The primary outcome is the main question the study is designed to answer.
incident cardiovascular disease
cardiovascular death, stroke, myocardial infarction, heart failure
Measured: mean follow up of 10 years
Secondary outcomes (12)
incident cancer
total and cause specific cancers
Measured: mean follow up of 10 years
Incident COPD
development of COPD
Measured: mean follow up of 10 years
Incident Asthma
development of asthma
Measured: mean follow up of 10 years
Pneumonia
hospitalization for pneumonia
Measured: mean follow up of 10 years
Respiratory outcomes
change in pulmonary function test
Measured: mean follow up of 10 years
All Cause Hospitalizations
All cause hospitalizations
Measured: mean follow up of 10 years
Kidney disease
end stage renal disease, dialysis, transplant, changes in renal function
Measured: mean follow up of 10 years
All cause and cause specific mortality
death from all causes, and cause specific deaths
Measured: mean follow up of 10 years
incident diabetes
development of diabetes
Measured: mean follow up of 10 years
obesity
development of obesity, change in BMI
Measured: mean follow up of 10 years
hypertension
development of hypertension and changes in blood pressure
Measured: mean follow up of 10 years
incident injuries
assessing fatal and non-fatal injuries due road traffic accidents and falls
Measured: mean follow up of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Jan 2002
- 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 (64)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Ontario
- Responsible party
- Principal investigator, Salim Yusuf's office, Population Health Research Institute
- Investigators
- Salim Yusuf, DPhil, Principal investigator, Executive Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225586
- Sponsor's protocol ID
- PURE
- Acronym
- PURE
- Status last verified
- Jan 2024
- First submitted
- 19 Jul 2017
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: During study conduct only with the investigators who have participated /contributed to the study. Select summary data may be shared with policy makers for specific purposes.The study exec will consider specific requests for data analyses by non-contributing individuals 3 years after the study has been completed (i.e. complete recruitment and a minimum of 10 years follow up in all) and the participating investigators have had an opportunity to explore questions that they are interested in. Costs related to data curating ,and related efforts will need to be met by anybody not contributing to the study and requesting analyses
Publications
Dehghan M, Al Hamad N, Yusufali A, Nusrath F, Yusuf S, Merchant AT. Development of a semi-quantitative food frequency questionnaire for use in United Arab Emirates and Kuwait based on local foods. Nutr J. 2005 May 27;4:18. doi: 10.1186/1475-2891-4-18.
PubMed 15921524Merchant AT, Dehghan M, Chifamba J, Terera G, Yusuf S. Nutrient estimation from an FFQ developed for a Black Zimbabwean population. Nutr J. 2005 Dec 13;4:37. doi: 10.1186/1475-2891-4-37.
PubMed 16351722Merchant AT, Dehghan M. Food composition database development for between country comparisons. Nutr J. 2006 Jan 19;5:2. doi: 10.1186/1475-2891-5-2.
PubMed 16423289Vaz M, Bharathi AV, Thomas T, Yusuf S, Kurpad AV. The repeatability of self reported physical activity patterns in rural South India. Asia Pac J Clin Nutr. 2009;18(1):71-5.
PubMed 19329398Dehghan M, del Cerro S, Zhang X, Cuneo JM, Linetzky B, Diaz R, Merchant AT. Validation of a semi-quantitative Food Frequency Questionnaire for Argentinean adults. PLoS One. 2012;7(5):e37958. doi: 10.1371/journal.pone.0037958. Epub 2012 May 25.
PubMed 22662256Dehghan M, Martinez S, Zhang X, Seron P, Lanas F, Islam S, Merchant AT. Relative validity of an FFQ to estimate daily food and nutrient intakes for Chilean adults. Public Health Nutr. 2013 Oct;16(10):1782-8. doi: 10.1017/S1368980012004107. Epub 2012 Sep 21.
PubMed 22995762Dehghan M, Lopez Jaramillo P, Duenas R, Anaya LL, Garcia RG, Zhang X, Islam S, Merchant AT. Development and validation of a quantitative food frequency questionnaire among rural- and urban-dwelling adults in Colombia. J Nutr Educ Behav. 2012 Nov-Dec;44(6):609-13. doi: 10.1016/j.jneb.2010.10.001. Epub 2011 Jul 7.
PubMed 21737352Khatib R, Schwalm JD, Yusuf S, Haynes RB, McKee M, Khan M, Nieuwlaat R. Patient and healthcare provider barriers to hypertension awareness, treatment and follow up: a systematic review and meta-analysis of qualitative and quantitative studies. PLoS One. 2014 Jan 15;9(1):e84238. doi: 10.1371/journal.pone.0084238. eCollection 2014.
PubMed 24454721Teo K, Chow CK, Vaz M, Rangarajan S, Yusuf S; PURE Investigators-Writing Group. The Prospective Urban Rural Epidemiology (PURE) study: examining the impact of societal influences on chronic noncommunicable diseases in low-, middle-, and high-income countries. Am Heart J. 2009 Jul;158(1):1-7.e1. doi: 10.1016/j.ahj.2009.04.019.
PubMed 19540385Chow CK, Lock K, Teo K, Subramanian SV, McKee M, Yusuf S. Environmental and societal influences acting on cardiovascular risk factors and disease at a population level: a review. Int J Epidemiol. 2009 Dec;38(6):1580-94. doi: 10.1093/ije/dyn258. Epub 2009 Mar 4.
PubMed 19261658Bharathi AV, Kurpad AV, Thomas T, Yusuf S, Saraswathi G, Vaz M. Development of food frequency questionnaires and a nutrient database for the Prospective Urban and Rural Epidemiological (PURE) pilot study in South India: methodological issues. Asia Pac J Clin Nutr. 2008;17(1):178-85.
PubMed 18364343Iqbal R, Ajayan K, Bharathi AV, Zhang X, Islam S, Soman CR, Merchant AT. Refinement and validation of an FFQ developed to estimate macro- and micronutrient intakes in a south Indian population. Public Health Nutr. 2009 Jan;12(1):12-8. doi: 10.1017/S1368980008001845. Epub 2008 Mar 7.
PubMed 18325134Chow CK, Lock K, Madhavan M, Corsi DJ, Gilmore AB, Subramanian SV, Li W, Swaminathan S, Lopez-Jaramillo P, Avezum A, Lear SA, Dagenais G, Teo K, McKee M, Yusuf S. Environmental Profile of a Community's Health (EPOCH): an instrument to measure environmental determinants of cardiovascular health in five countries. PLoS One. 2010 Dec 10;5(12):e14294. doi: 10.1371/journal.pone.0014294.
PubMed 21170320Mir H, Buchanan D, Gilmore A, McKee M, Yusuf S, Chow CK. Cigarette pack labelling in 12 countries at different levels of economic development. J Public Health Policy. 2011 May;32(2):146-64. doi: 10.1057/jphp.2011.3. Epub 2011 Mar 3.
PubMed 21368847Yusuf S, Islam S, Chow CK, Rangarajan S, Dagenais G, Diaz R, Gupta R, Kelishadi R, Iqbal R, Avezum A, Kruger A, Kutty R, Lanas F, Lisheng L, Wei L, Lopez-Jaramillo P, Oguz A, Rahman O, Swidan H, Yusoff K, Zatonski W, Rosengren A, Teo KK; Prospective Urban Rural Epidemiology (PURE) Study Investigators. Use of secondary prevention drugs for cardiovascular disease in the community in high-income, middle-income, and low-income countries (the PURE Study): a prospective epidemiological survey. Lancet. 2011 Oct 1;378(9798):1231-43. doi: 10.1016/S0140-6736(11)61215-4. Epub 2011 Aug 26.
PubMed 21872920
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Urban Rural Epidemiology Study
- ClinicalTrials.gov ID
- NCT03225586
- Acronym / sponsor ID
- PURE / PURE
- Conditions
- Cardiovascular Diseases, Risk Factor, Cardiovascular, Health Behavior, Environmental Exposure, Lung Diseases, Cancer
- Keywords
- Non-communicable Diseases, Risk Factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Ontario
- Study start
- 1 Jan 2002 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine the impact of health determinants at the individual (e.g. health related behaviors) and societal level (e.g. environmental factors, health related policy, quality of health systems) on health outcomes (e.g. death, non-communicable disease development) across a range of socioeconomic and health resource settings. Additional components of this study will examine genetic factors for non-communicable diseases. This will be examined both through a cross sectional component, and prospectively (cohort component).
Detailed description
- To examine the relationship between societal influences and prevalence of risk factors and chronic noncommunicable diseases. Societal determinants are measured by an index of measures from each of the 4 domains of interest: built environment, food and nutrition policy, psychosocial/socioeconomic factors, and tobacco.
- To examine the relationship between societal determinants and incidence of chronic noncommunicable disease events (e.g. cardiovascular disease, cancer) and on changes in rates of selected risk factors (e.g. smoking)
- To examine the relationship between health related behaviors (e.g. diet, physical activity, smoking, alcohol) and health outcomes (e.g. death, non-communicable diseases)
- The quality of health systems across a diverse range of health resource settings, and how this impacts health outcomes
- Genetic factors for non-communicable diseases
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults | – | –Between 35 to 70 years of age at time of enrollment |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults aged 35 to 70 years from communities in low-, middle-, and high-income regions of the world representing various levels of development and encompassing great sociocultural diversity.
Key inclusion criteria (1 listed)
- consenting adults between 35-70 years of age
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incident cardiovascular disease
Time frame: mean follow up of 10 years
cardiovascular death, stroke, myocardial infarction, heart failure
12 secondary outcomes
incident cancer
Time frame: mean follow up of 10 years
Incident COPD
Time frame: mean follow up of 10 years
Incident Asthma
Time frame: mean follow up of 10 years
Pneumonia
Time frame: mean follow up of 10 years
Respiratory outcomes
Time frame: mean follow up of 10 years
All Cause Hospitalizations
Time frame: mean follow up of 10 years
Kidney disease
Time frame: mean follow up of 10 years
All cause and cause specific mortality
Time frame: mean follow up of 10 years
incident diabetes
Time frame: mean follow up of 10 years
obesity
Time frame: mean follow up of 10 years
hypertension
Time frame: mean follow up of 10 years
incident injuries
Time frame: mean follow up of 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Background: PubMed 15921524Dehghan M, Al Hamad N, Yusufali A, Nusrath F, Yusuf S, Merchant AT. Development of a semi-quantitative food frequency questionnaire for use in United Arab Emirates and Kuwait based on local foods. Nutr J. 2005 May 27;4:18. doi: 10.1186/1475-2891-4-18.
- Background: PubMed 16351722Merchant AT, Dehghan M, Chifamba J, Terera G, Yusuf S. Nutrient estimation from an FFQ developed for a Black Zimbabwean population. Nutr J. 2005 Dec 13;4:37. doi: 10.1186/1475-2891-4-37.
- Background: PubMed 16423289Merchant AT, Dehghan M. Food composition database development for between country comparisons. Nutr J. 2006 Jan 19;5:2. doi: 10.1186/1475-2891-5-2.
- Background: PubMed 19329398Vaz M, Bharathi AV, Thomas T, Yusuf S, Kurpad AV. The repeatability of self reported physical activity patterns in rural South India. Asia Pac J Clin Nutr. 2009;18(1):71-5.
- Background: PubMed 22662256Dehghan M, del Cerro S, Zhang X, Cuneo JM, Linetzky B, Diaz R, Merchant AT. Validation of a semi-quantitative Food Frequency Questionnaire for Argentinean adults. PLoS One. 2012;7(5):e37958. doi: 10.1371/journal.pone.0037958. Epub 2012 May 25.
- Background: PubMed 22995762Dehghan M, Martinez S, Zhang X, Seron P, Lanas F, Islam S, Merchant AT. Relative validity of an FFQ to estimate daily food and nutrient intakes for Chilean adults. Public Health Nutr. 2013 Oct;16(10):1782-8. doi: 10.1017/S1368980012004107. Epub 2012 Sep 21.
- Background: PubMed 21737352Dehghan M, Lopez Jaramillo P, Duenas R, Anaya LL, Garcia RG, Zhang X, Islam S, Merchant AT. Development and validation of a quantitative food frequency questionnaire among rural- and urban-dwelling adults in Colombia. J Nutr Educ Behav. 2012 Nov-Dec;44(6):609-13. doi: 10.1016/j.jneb.2010.10.001. Epub 2011 Jul 7.
- Background: PubMed 24454721Khatib R, Schwalm JD, Yusuf S, Haynes RB, McKee M, Khan M, Nieuwlaat R. Patient and healthcare provider barriers to hypertension awareness, treatment and follow up: a systematic review and meta-analysis of qualitative and quantitative studies. PLoS One. 2014 Jan 15;9(1):e84238. doi: 10.1371/journal.pone.0084238. eCollection 2014.
- Results publication: PubMed 19540385Teo K, Chow CK, Vaz M, Rangarajan S, Yusuf S; PURE Investigators-Writing Group. The Prospective Urban Rural Epidemiology (PURE) study: examining the impact of societal influences on chronic noncommunicable diseases in low-, middle-, and high-income countries. Am Heart J. 2009 Jul;158(1):1-7.e1. doi: 10.1016/j.ahj.2009.04.019.
- Results publication: PubMed 19261658Chow CK, Lock K, Teo K, Subramanian SV, McKee M, Yusuf S. Environmental and societal influences acting on cardiovascular risk factors and disease at a population level: a review. Int J Epidemiol. 2009 Dec;38(6):1580-94. doi: 10.1093/ije/dyn258. Epub 2009 Mar 4.
- Results publication: PubMed 18364343Bharathi AV, Kurpad AV, Thomas T, Yusuf S, Saraswathi G, Vaz M. Development of food frequency questionnaires and a nutrient database for the Prospective Urban and Rural Epidemiological (PURE) pilot study in South India: methodological issues. Asia Pac J Clin Nutr. 2008;17(1):178-85.
- Results publication: PubMed 18325134Iqbal R, Ajayan K, Bharathi AV, Zhang X, Islam S, Soman CR, Merchant AT. Refinement and validation of an FFQ developed to estimate macro- and micronutrient intakes in a south Indian population. Public Health Nutr. 2009 Jan;12(1):12-8. doi: 10.1017/S1368980008001845. Epub 2008 Mar 7.
- Study WebpageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. During study conduct only with the investigators who have participated /contributed to the study. Select summary data may be shared with policy makers for specific purposes.The study exec will consider specific requests for data analyses by non-contributing individuals 3 years after the study has been completed (i.e. complete recruitment and a minimum of 10 years follow up in all) and the participating investigators have had an opportunity to explore questions that they are interested in. Costs related to data curating ,and related efforts will need to be met by anybody not contributing to the study and requesting analyses
Related trials for Cardiovascular Diseases
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
RecruitingPhase 1/2
A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma
Relapsed/Refractory Multiple Myeloma
RecruitingPhase 2
Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Lymphoplasmacytic Lymphoma, Waldenstrom Macroglobulinemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salim Yusuf, DPhil principal investigator
Executive Director
34 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Risk Factor, Cardiovascular, run by Population Health Research Institute at 34 sites in 25 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in India, Canada, Malaysia, South Africa, Argentina and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sumathy Rangarajan, MSc (905-521-2100 ext. 40464, sumathy.rangarajan@phri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incident cardiovascular disease (time frame: mean follow up of 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03225586, which also lists 64 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.