Prospective Urban Rural Epidemiology Study (PURE)

January 29, 2024 updated by: Salim Yusuf's office, Population Health Research Institute
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).

Study Overview

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

Enrollment (Estimated)

200000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Santa Fe
      • São Paulo, Brazil
        • Recruiting
        • Dante Pazzanese Institute of Cardiology
        • Contact:
    • British Columbia
    • Ontario
      • Hamilton, Ontario, Canada, L8L2X2
        • Recruiting
        • Population Health Research Institute
        • Contact:
        • Principal Investigator:
          • Koon Teo, MB, PhD
      • Ottawa, Ontario, Canada, K1H8L6
        • Recruiting
        • University of Ottawa
        • Contact:
    • Quebec
      • Quebec City, Quebec, Canada
        • Recruiting
        • Université Laval Institut universitaire de cardiologie et de pneumologie de Québec
        • Contact:
      • Temuco, Chile
        • Recruiting
        • Universidad de La Frontera
        • Contact:
      • Beijing, China
        • Recruiting
        • State Key Laboratory of Cardiovascular Disease, Fuwai Hospital
        • Contact:
    • Santander
      • Floridablanca, Santander, Colombia
        • Recruiting
        • Fundacion Oftalmologica de Santander - FOSCAL
        • Contact:
      • Chandigarh, India
        • Recruiting
        • Post Graduate Institute of Medical Education and Research (PGIMER)
        • Contact:
    • Karnataka
      • Bangalore, Karnataka, India
        • Recruiting
        • St John's Research Institute
        • Contact:
    • Kerala
      • Thiruvananthapuram, Kerala, India
        • Recruiting
        • Health Action by People
        • Contact:
    • Rajasthan
      • Jaipur, Rajasthan, India
        • Recruiting
        • Eternal Heart Care Centre and Research Institute
        • Contact:
    • Tamil Nadu
      • Chennai, Tamil Nadu, India
      • Isfahan, Iran, Islamic Republic of
      • Almaty, Kazakhstan
        • Recruiting
        • Research Institute of Cardiology & Internal Diseases
        • Contact:
      • Bishkek, Kyrgyzstan
        • Recruiting
        • Kyrgyz Society of Cardiology, National Center of Cardiology and Internal Disease
        • Contact:
      • Kuala Lumpur, Malaysia
        • Recruiting
        • Universiti Teknologi MARA, UCSI Universiti
        • Contact:
      • Kuala Lumpur, Malaysia
        • Recruiting
        • University Kebangsaan Malaysia
        • Contact:
      • Karachi, Pakistan
      • Ramallah, Palestinian Territory, occupied
      • Lima, Peru
        • Recruiting
        • Universidad Peruana Cayetano Heredia
        • Contact:
      • Manila, Philippines
        • Recruiting
        • University of Philippines, Section of Adult Medicine & Medical Research Unit
        • Contact:
      • Wrocław, Poland
        • Recruiting
        • Wroclaw Medical University & Department of Internal Medicine
        • Contact:
      • Kemerovo, Russian Federation
        • Recruiting
        • Research Institute for Complex Issues of Cardiovascular Diseases
        • Contact:
      • Bellville, South Africa
        • Recruiting
        • School of Public Health, University of the Western Cape
        • Contact:
      • Potchefstroom, South Africa
      • Göteborg, Sweden
        • Recruiting
        • Sahlgrenska University Hospital/Östra Hospital
        • Contact:
      • Moshi, Tanzania
        • Recruiting
        • Pamoja Tunaweza Women Center
        • Contact:
      • İstanbul, Turkey
      • Dubai, United Arab Emirates
      • Harare, Zimbabwe
        • Recruiting
        • University of Zimbabwe College of Health Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

Inclusion Criteria:

  • consenting adults between 35-70 years of age

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incident cardiovascular disease
Time Frame: mean follow up of 10 years
cardiovascular death, stroke, myocardial infarction, heart failure
mean follow up of 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incident cancer
Time Frame: mean follow up of 10 years
total and cause specific cancers
mean follow up of 10 years
Incident COPD
Time Frame: mean follow up of 10 years
development of COPD
mean follow up of 10 years
Incident Asthma
Time Frame: mean follow up of 10 years
development of asthma
mean follow up of 10 years
Pneumonia
Time Frame: mean follow up of 10 years
hospitalization for pneumonia
mean follow up of 10 years
Respiratory outcomes
Time Frame: mean follow up of 10 years
change in pulmonary function test
mean follow up of 10 years
All Cause Hospitalizations
Time Frame: mean follow up of 10 years
All cause hospitalizations
mean follow up of 10 years
Kidney disease
Time Frame: mean follow up of 10 years
end stage renal disease, dialysis, transplant, changes in renal function
mean follow up of 10 years
All cause and cause specific mortality
Time Frame: mean follow up of 10 years
death from all causes, and cause specific deaths
mean follow up of 10 years
incident diabetes
Time Frame: mean follow up of 10 years
development of diabetes
mean follow up of 10 years
obesity
Time Frame: mean follow up of 10 years
development of obesity, change in BMI
mean follow up of 10 years
hypertension
Time Frame: mean follow up of 10 years
development of hypertension and changes in blood pressure
mean follow up of 10 years
incident injuries
Time Frame: mean follow up of 10 years
assessing fatal and non-fatal injuries due road traffic accidents and falls
mean follow up of 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Salim Yusuf, DPhil, Executive Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2002

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

July 19, 2017

First Submitted That Met QC Criteria

July 19, 2017

First Posted (Actual)

July 21, 2017

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Time Frame

complete recruitment and a minimum of 10 years follow up in all

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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