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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: * 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
Age
21 - 80 years
Sex
ALL
Healthy Volunteers
No
NIDDK-Phoenix Epidemiology and Clinical Research
Phoenix, Arizona, United States
First Nations Community Health Source
Albuquerque, New Mexico, United States
Zuni Health Initiative Center
Black Rock, New Mexico, United States
Start Date
August 31, 2020
Primary Completion Date
June 30, 2028
Completion Date
June 30, 2028
Last Updated
May 15, 2025
500
ESTIMATED participants
Lead Sponsor
University of New Mexico
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07480161