[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04185844":3,"trial-entities:NCT04185844":98,"trial-summary:NCT04185844":104},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":30,"secondary_outcomes":35,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":14,"eligibility_criteria":50,"std_ages":55,"locations":58,"central_contacts":84,"overall_officials":90,"references":93,"see_also_links":94},"NCT04185844","19-159","American Indian Chronic Renal Insufficiency Cohort Study (AI-CRIC Study)","RECRUITING","2028-06-30","2026-05","2026-05-20","2020-08-31","University of New Mexico","OTHER",false,"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.\n\nAt the Clinic Visit the following will occur:\n\n* weight is measured\n* blood pressure and heart rate are recorded\n* information about medical history and medication used recently\n* blood draw (about ½ cup) for the following tests: CBC (Complete Blood Count), tests of metabolism, and several other heart and kidney tests\n* blood pressure in the leg and arm calculated as the Ankle Brachial Index (ABI)\n* urine sample collection for kidney function testing\n* complete questionnaires about quality of life, diet, mood, thought processes and physical activity.\n\nThis 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.\n\nParticipants 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.\n\nAdditionally, 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",[18,19,20,21],"Diabetes Mellitus","Chronic Kidney Diseases","Heart Diseases","Cardiovascular Diseases",[],"OBSERVATIONAL",null,[],{"count":27,"type":28},500,"ESTIMATED",[],[31],{"measure":32,"description":33,"timeFrame":34},"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",[36,39,41,44],{"measure":37,"description":38,"timeFrame":34},"Onset of End Stage Renal Disease","The measure is reflected in decline of GFR levels",{"measure":40,"description":38,"timeFrame":34},"Significant loss of renal function",{"measure":42,"description":43,"timeFrame":34},"Composite clinical outcome defined by the occurrence of either 50% decline, or 25 l\u002Fmin\u002F1.73 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",{"measure":45,"description":46,"timeFrame":34},"Slope of change in proteinuria over time","The changes in the levels of proteinuria overtime","ALL","21 Years","80 Years",{"inclusion":51,"exclusion":53,"raw_text":54},[52],"Glomerular Filtration Rate (GFR): eGFR of =\\>61\\\u003C80 and microalbuminuria \\> 30 or eGRF of =\\\u003C60 (no microalbuminuria required).",[],"Inclusion Criteria:\n\n* Glomerular Filtration Rate (GFR): eGFR of =\\>61\\\u003C80 and microalbuminuria \\> 30 or eGRF of =\\\u003C60 (no microalbuminuria required).\n\nExclusion Criteria:\n\n1. Unable or unwilling to provide informed consent\n2. life expectancy \\\u003C3 years;\n3. institutionalized subjects;\n4. End stage renal disease or renal transplant;\n5. renal cancer;\n6. myeloma;\n7. immunosuppression;\n8. Polycystic kidney disease;\n9. participation in any clinical trial,\n10. current pregnancy\n11. current incarceration.\n12. Appears unlikely or unable to participate in the required study procedures as assessed by the investigator, study coordinator or designee.",[56,57],"ADULT","OLDER_ADULT",[59,69,77],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"geoPoint":66},"NIDDK-Phoenix Epidemiology and Clinical Research","NOT_YET_RECRUITING","Phoenix","Arizona","85016","United States",{"lat":67,"lon":68},33.44838,-112.07404,{"facility":70,"status":7,"city":71,"state":72,"zip":73,"country":65,"geoPoint":74},"First Nations Community Health Source","Albuquerque","New Mexico","87108",{"lat":75,"lon":76},35.08449,-106.65114,{"facility":78,"status":7,"city":79,"state":72,"zip":80,"country":65,"geoPoint":81},"Zuni Health Initiative Center","Black Rock","87327",{"lat":82,"lon":83},35.08837,-108.79119,[85],{"name":86,"role":87,"phone":88,"email":89},"Mark L Unruh, MD","CONTACT","505-272-8300","MLUnruh@salud.unm.edu",[91],{"name":86,"affiliation":12,"role":92},"PRINCIPAL_INVESTIGATOR",[],[95],{"label":96,"url":97},"Chronic Renal Insufficiency cohort study","http:\u002F\u002Fwww.cristudy.org\u002FChronic-Kidney-Disease\u002FChronic-Renal-Insufficiency-Cohort-Study\u002Fabout",{"nct_id":4,"conditions":99,"biomarkers":103},[100,101,18,102],"Cardiovascular Disorder","Chronic Kidney Disease","Heart Disorder",[],{"nct_id":4,"found":105,"summary":106,"prompt_version":116},true,{"design":107,"status":108,"heading":109,"summary":110,"follow_up":111,"word_count":112,"commitments":113,"compensation":114,"drugs_mentioned":115},"This is an observational study planning to enroll 500 participants. It does not involve a specific intervention or drug.","completed","AI-CRIC Study: Understanding Kidney and Heart Disease in American Indians","This observational study, called the American Indian Chronic Renal Insufficiency Cohort Study (AI-CRIC), aims to better understand chronic kidney disease (CKD) and heart disease in American Indian communities. Researchers want to identify unique risk factors for these conditions and compare how they progress in American Indians versus other populations. You might be eligible if you are between 21 and 80 years old and have certain levels of kidney function (eGFR of 61-80 with microalbuminuria, or eGFR of 60 or less). The study will look at how your kidney function changes over 5 years. The current status of this study is unclear.","Participants will be followed annually, and the primary endpoint for kidney function change is measured at 5 years.",101,"You will have an initial clinic visit lasting 1-2 hours, which includes measurements, blood draws, urine collection, and questionnaires. You will also have phone calls six months after your first visit and annual follow-up visits.","Not stated in the trial record.",[],"v2"]