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Prospective Urban Rural Epidemiology Study (PURE)

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ClinicalTrials.gov Identifier: NCT03225586
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : September 21, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Salim Yusuf's office, Population Health Research Institute

Brief 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. 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).

Condition or disease
Cardiovascular Diseases Risk Factor, Cardiovascular Health Behavior Environmental Exposure Lung Diseases Cancer Injuries Renal Disease Communicable Disease

Detailed Description:
  1. 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.
  2. 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)
  3. To examine the relationship between health related behaviors (e.g. diet, physical activity, smoking, alcohol) and health outcomes (e.g. death, non-communicable diseases)
  4. The quality of health systems across a diverse range of health resource settings, and how this impacts health outcomes
  5. Genetic factors for non-communicable diseases

Study Type : Observational
Estimated Enrollment : 200000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Urban Rural Epidemiology Study
Actual Study Start Date : January 1, 2002
Estimated Primary Completion Date : December 31, 2030
Estimated Study Completion Date : December 31, 2030

Group/Cohort
Adults
Between 35 to 70 years of age at time of enrollment



Primary Outcome Measures :
  1. incident cardiovascular disease [ Time Frame: mean follow up of 10 years ]
    cardiovascular death, stroke, myocardial infarction, heart failure


Secondary Outcome Measures :
  1. incident cancer [ Time Frame: mean follow up of 10 years ]
    total and cause specific cancers

  2. Incident COPD [ Time Frame: mean follow up of 10 years ]
    development of COPD

  3. Incident Asthma [ Time Frame: mean follow up of 10 years ]
    development of asthma

  4. Pneumonia [ Time Frame: mean follow up of 10 years ]
    hospitalization for pneumonia

  5. Respiratory outcomes [ Time Frame: mean follow up of 10 years ]
    change in pulmonary function test

  6. All Cause Hospitalizations [ Time Frame: mean follow up of 10 years ]
    All cause hospitalizations

  7. Kidney disease [ Time Frame: mean follow up of 10 years ]
    end stage renal disease, dialysis, transplant, changes in renal function

  8. All cause and cause specific mortality [ Time Frame: mean follow up of 10 years ]
    death from all causes, and cause specific deaths

  9. incident diabetes [ Time Frame: mean follow up of 10 years ]
    development of diabetes

  10. obesity [ Time Frame: mean follow up of 10 years ]
    development of obesity, change in BMI

  11. hypertension [ Time Frame: mean follow up of 10 years ]
    development of hypertension and changes in blood pressure

  12. injuries [ Time Frame: mean follow up of 10 years ]
    assessing fatal and non-fatal injuries due road traffic accidents and falls


Biospecimen Retention:   Samples With DNA
Whole blood, Serum, Plasma, Urine


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Both Men and Women
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • consenting adults between 35-70 years of age

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03225586


Contacts
Contact: Sumathy Rangarajan, MSc 905-521-2100 ext 40464 sumathy.rangarajan@phri.ca
Contact: Janette Panhuis, BScN, MBA 905-521-2100 ext 40386 janette.panhuis@phri.ca

  Hide Study Locations
Locations
Argentina
Estudios Clinicos Latinoamerica ECLA Recruiting
Rosario, Santa Fe, Argentina
Contact: Rafael Diaz, MD       rdiazmd@eclainternational.org   
Bangladesh
Independent University, Bangladesh Recruiting
Dhaka, Bangladesh
Contact: Omar Rahman, MD, MPH, DSc       orahman@iub.edu.bd   
Contact: Rita Yusuf, PhD       ritayusuf@iub.edu.bd   
Brazil
Dante Pazzanese Institute of Cardiology Recruiting
São Paulo, Brazil
Contact: Alvaro Avezum, MD. PhD       avezum@yahoo.com   
Canada, British Columbia
Simon Fraser University Recruiting
Vancouver, British Columbia, Canada
Contact: Scott Lear, PhD       SLear@providencehealth.bc.ca   
Canada, Ontario
Population Health Research Institute Recruiting
Hamilton, Ontario, Canada, L8L2X2
Contact: Sandy Trottier    905-521-2100 ext 40456    sandy.trottier@phri.ca   
Principal Investigator: Koon Teo, MB, PhD         
University of Ottawa Recruiting
Ottawa, Ontario, Canada, K1H8L6
Contact: Andreas Wielgosz, MD, PhD       wielgosz@uottawa.ca   
Canada, Quebec
Université Laval Institut universitaire de cardiologie et de pneumologie de Québec Recruiting
Quebec City, Quebec, Canada
Contact: Gilles Dagenais, MD       Gilles.Dagenais@criucpq.ulaval.ca   
Chile
Universidad de La Frontera Recruiting
Temuco, Chile
Contact: Fernando Lanas, MD, MSc       lanastomas@gmail.com   
China
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital Recruiting
Beijing, China
Contact: Wei Li, PhD       liwei@mrbc-nccd.com   
Colombia
Fundacion Oftalmologica de Santander - FOSCAL Recruiting
Floridablanca, Santander, Colombia
Contact: Patricio Lopez-Jaramillo, MD, PhD       jplopezj@gmail.com   
India
St John's Research Institute Recruiting
Bangalore, Karnataka, India
Contact: Prem K Mony, MD, MSc       premkmony@gmail.com   
Health Action by People Recruiting
Thiruvananthapuram, Kerala, India
Contact: Raman Kutty, MD, MPH       kuttyr@gmail.com   
Eternal Heart Care Centre and Research Institute Recruiting
Jaipur, Rajasthan, India
Contact: Rajeev Gupta, MD, PhD       rajeevgg@gmail.com   
Madras Diabetes Research Foundation Recruiting
Chennai, Tamil Nadu, India
Contact: V Mohan, MD       drmohans@diabetes.ind.in   
Post Graduate Institute of Medical Education and Research (PGIMER) Recruiting
Chandigarh, India
Contact: Rajesh Kumar, MD       dr.rajeshkumar@gmail.com   
Iran, Islamic Republic of
Isfahan University of Medical Sciences Recruiting
Isfahan, Iran, Islamic Republic of
Contact: Roya Kelishadi, MD       roya.kelishadi@gmail.com   
Kazakhstan
Research Institute of Cardiology & Internal Diseases Recruiting
Almaty, Kazakhstan
Contact: Kairat Davletov, MD       davletovkairat@gmail.com   
Kyrgyzstan
Kyrgyz Society of Cardiology, National Center of Cardiology and Internal Disease Recruiting
Bishkek, Kyrgyzstan
Contact: Erkin Mirrakhimov, MD       erkmirr@gmail.com   
Malaysia
Universiti Teknologi MARA, UCSI Universiti Recruiting
Kuala Lumpur, Malaysia
Contact: Khalid Yusoff, MBBS       kyusoff@gmail.com   
University Kebangsaan Malaysia Recruiting
Kuala Lumpur, Malaysia
Contact: Noorhassim Ismail, MD       ramalbaru@gmail.com   
Pakistan
Aga Khan University Recruiting
Karachi, Pakistan
Contact: Romaina Iqbal, PhD       romaina.iqbal@aku.edu   
Palestinian Territory, occupied
Birzeit University, Birzeit Recruiting
Ramallah, Palestinian Territory, occupied
Contact: Rasha Khatib, PhD       Rasha.Khatib@phri.ca   
Peru
Universidad Peruana Cayetano Heredia Recruiting
Lima, Peru
Contact: Jaime Miranda, MD, PhD       jaime.miranda@upch.pe   
Philippines
University of Philippines, Section of Adult Medicine & Medical Research Unit Recruiting
Manila, Philippines
Contact: Antonio L Dans, MD       antoniodans@gmail.com   
Poland
Wroclaw Medical University & Department of Internal Medicine Recruiting
Wrocław, Poland
Contact: Andrzej Szuba, MD, PhD       andrzej.szuba@umed.wroc.pl   
Russian Federation
Research Institute for Complex Issues of Cardiovascular Diseases Recruiting
Kemerovo, Russian Federation
Contact: Olga Barbarash       olb61@mail.ru   
Saudi Arabia
King Saud University Recruiting
Riyadh, Saudi Arabia
Contact: Khalid F AlHabib, MBBS       khalidalhabib13@hotmail.com   
South Africa
School of Public Health, University of the Western Cape Recruiting
Bellville, South Africa
Contact: Thandi Puoane, MPH, Dr PH       tpuoane@uwc.ac.za   
North-West University Recruiting
Potchefstroom, South Africa
Contact: Lanthe Kruger, PhD       lanthe.kruger@nwu.ac.za   
Sweden
Sahlgrenska University Hospital/Östra Hospital Recruiting
Göteborg, Sweden
Contact: Annika Rosengren, MD, PhD       annika.rosengren@gu.se   
Tanzania
Pamoja Tunaweza Women Center Recruiting
Moshi, Tanzania
Contact: Karen Yeates, MD       yeatesk@queensu.ca   
Turkey
Istanbul Medeniyet University Recruiting
İstanbul, Turkey
Contact: Aytekin Oguz, MD       aytekinoguz@hotmail.com   
United Arab Emirates
Dubai Medical University Recruiting
Dubai, United Arab Emirates
Contact: Afzalhussein Yusufali, MD       ahYusufali@dha.gov.ae   
Zimbabwe
University of Zimbabwe College of Health Sciences Recruiting
Harare, Zimbabwe
Contact: Jephat Chifamba, DPhil       chifamb@medic.uz.ac.zw   
Sponsors and Collaborators
Population Health Research Institute
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Ontario
Investigators
Principal Investigator: Salim Yusuf, DPhil Executive Director

Additional Information:
Publications of Results:

Other Publications:

Responsible Party: Salim Yusuf's office, Executive Director, Population Health Research Institute, Principal Investigator, Population Health Research Institute
ClinicalTrials.gov Identifier: NCT03225586     History of Changes
Other Study ID Numbers: PURE
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: complete recruitment and a minimum of 10 years follow up in all
Access Criteria: 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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Salim Yusuf's office, Population Health Research Institute:
Non-communicable Diseases, Risk Factors

Additional relevant MeSH terms:
Cardiovascular Diseases
Lung Diseases
Communicable Diseases
Infection
Respiratory Tract Diseases