Меню
Идёт набор NCT04185844

American Indian Chronic Renal Insufficiency Cohort Study (AI-CRIC Study)

— Наблюдательное Diabetes Mellitus Chronic Kidney Diseases Heart Diseases Cardiovascular Diseases

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Diabetes Mellitus, Chronic Kidney Diseases, Heart Diseases, Cardiovascular Diseases. Базовые параметры: 21 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

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.

Подробное описание

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

Первичные конечные точки

  • Slope of the GFR [Срок оценки: 5 years]
Вторичные конечные точки (4)
  • Onset of End Stage Renal Disease [Срок оценки: 5 years]
  • Significant loss of renal function [Срок оценки: 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 [Срок оценки: 5 years]
  • Slope of change in proteinuria over time [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • Glomerular Filtration Rate (GFR): eGFR of =>61<80 and microalbuminuria > 30 or eGRF of =<60 (no microalbuminuria required).

Критерии исключения

  • Unable or unwilling to provide informed consent
  • life expectancy <3 years;
  • institutionalized subjects;
  • End stage renal disease or renal transplant;
  • renal cancer;
  • myeloma;
  • immunosuppression;
  • Polycystic kidney disease;
  • participation in any clinical trial,
  • current pregnancy
  • current incarceration.
  • Appears unlikely or unable to participate in the required study procedures as assessed by the investigator, study coordinator or designee.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 3 центра
  • NIDDK-Phoenix Epidemiology and Clinical Research — Phoenix
  • First Nations Community Health Source — Albuquerque
  • Zuni Health Initiative Center — Black Rock

Идентификаторы

NCT: NCT04185844 · 19-159

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗