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Despite many advances in our understanding of the natural history and progression of chronic kidney disease (CKD) and cardio vascular disease (CVD) in the parent CRIC study over the past 15 years, important questions about key risk factors for these diseases remain unanswered in the AI population. To address this burden of CKD in AI communities Investigators formed a consortium of investigators with extensive experience in conducting research of chronic diseases including diabetes, cardiovascular and kidney disease in AIs of Southwestern US. The proposed CRIC ancillary cohort study of 500 AIs (AI-CRIC) will rapidly improve our understanding of both potential risk factors for CKD progression, as well as the scope of this disease among AIs. This study leverages the current CRIC study and incorporates the planned activities of the next phase of the study - "CRIC 2018" - by implementing contemporary CRIC protocols for kidney and cardiovascular measurement and outcomes.
Investigators will conduct a longitudinal study of a CKD cohort of Southwest AIs to identify unique risk factors for CKD and CVD progression and compare CKD and CVD event rates and risk factors between AI and the populations represented in CRIC. Investigators will establish a specimen bank to support future ancillary studies designed to identify and examine biomarkers associated with the progression of CKD in AIs.
At the Clinic Visit the following will occur:
This visit takes about 1 to 2 hours. Participants will be contacted by telephone six months after the Baseline Visit to ask about recent medical events and medications.
Participants will be asked to return to the center for annual visits during which many but not all of the procedures described above will be conducted.
Additionally, participants will be asked to participate in one of two substudies using remote data collection techniques to identify trajectories of kidney function and cardiovascular risk sub-phenotypes
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| Measure | Description | Time Frame |
|---|---|---|
| Slope of the GFR | Primary outcomes regarding Cardio vascular disease will focus on clinical events indicative of ischemic heart disease, CHF, stroke, and peripheral vascular disease supplemented by radiographic evidence of progressive CVD. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of End Stage Renal Disease | The measure is reflected in decline of GFR levels | 5 years |
| Significant loss of renal function | The measure is reflected in decline of GFR levels |
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Inclusion Criteria:
Exclusion Criteria:
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American Indians at 3 sites.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark L Unruh, MD | Contact | 505-272-8300 | MLUnruh@salud.unm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mark L Unruh, MD | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIDDK-Phoenix Epidemiology and Clinical Research | Not yet recruiting | Phoenix | Arizona | 85016 | United States | |
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| Label | URL |
|---|---|
| Chronic Renal Insufficiency cohort study | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D051436 | Renal Insufficiency, Chronic |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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blood, urine serum, plasma, DNA, RNA
| 5 years |
| Composite clinical outcome defined by the occurrence of either 50% decline, or 25 l/min/1.73 m2 decline in GFR from baseline, or onset of ESRD | The composite clinical outcome includes onset of End Stage Renal Disease, Significant loss of renal function or changes in proteinuria over time from baseline | 5 years |
| Slope of change in proteinuria over time | The changes in the levels of proteinuria overtime | 5 years |
| First Nations Community Health Source |
| Recruiting |
| Albuquerque |
| New Mexico |
| 87108 |
| United States |
| Zuni Health Initiative Center | Recruiting | Black Rock | New Mexico | 87327 | United States |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |