American Indian Chronic Renal Insufficiency Cohort Study (AI-CRIC Study) (AI-CRIC)
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|ClinicalTrials.gov Identifier: NCT04185844|
Recruitment Status : Not yet recruiting
First Posted : December 4, 2019
Last Update Posted : December 4, 2019
|Condition or disease|
|Diabetes Mellitus Chronic Kidney Diseases Heart Diseases Cardiovascular Diseases|
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:
- weight is measured
- blood pressure and heart rate are recorded
- information about medical history and medication used recently
- blood draw (about ½ cup) for the following tests: CBC (Complete Blood Count), tests of metabolism, and several other heart and kidney tests
- blood pressure in the leg and arm calculated as the Ankle Brachial Index (ABI)
- urine sample collection for kidney function testing
- complete questionnaires about quality of life, diet, mood, thought processes and physical activity.
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
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||American Indian Chronic Renal Insufficiency Cohort Study (AI-CRIC Study)|
|Estimated Study Start Date :||January 6, 2020|
|Estimated Primary Completion Date :||January 1, 2024|
|Estimated Study Completion Date :||June 30, 2024|
- Slope of the GFR [ Time Frame: 5 years ]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.
- Onset of End Stage Renal Disease [ Time Frame: 5 years ]The measure is reflected in decline of GFR levels
- Significant loss of renal function [ Time Frame: 5 years ]The measure is reflected in decline of GFR levels
- 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 [ Time Frame: 5 years ]The composite clinical outcome includes onset of End Stage Renal Disease, Significant loss of renal function or changes in proteinuria over time from baseline
- Slope of change in proteinuria over time [ Time Frame: 5 years ]The changes in the levels of proteinuria overtime
Biospecimen Retention: Samples With DNA
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): NCT04185844
|Contact: Vallabh Shah||505-272-9615||VShah@salud.unm.edu|
|United States, Arizona|
|NIDDK-Phoenix Epidemiology and Clinical Research||Not yet recruiting|
|Phoenix, Arizona, United States, 85016|
|United States, New Mexico|
|First Nations Community Health Source||Not yet recruiting|
|Albuquerque, New Mexico, United States, 87108|
|Zuni Health Initiative Center||Not yet recruiting|
|Black Rock, New Mexico, United States, 87327|
|Principal Investigator:||Vallabh Shah||University of New Mexico|