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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 : July 24, 2017
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

  Show 34 Study Locations
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: July 24, 2017
Last Verified: July 2017
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.
URL: http://

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