- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03135002
The Leicester City and County Chronic Kidney Disease Cohort (LCC-CKD)
The Leicester City and County Chronic Kidney Disease Study: An Observational Chronic Kidney Disease Cohort to Study Cardiovascular and Renal Outcomes in Multi-ethnicity Primary Care
Chronic kidney disease (CKD) is estimated to affect 6-8% of the adult population and is independently associated with increased cardiovascular (CV) disease risk. This risk increases as CKD advances both in relation to worsening glomerular filtration rate and development of proteinuria. The overall cost of CKD to the NHS (National Health Service) in England has been estimated as £1.45 billion per annum, or 1.3% of the NHS's total budget. This includes £175 million, or 13% of the CKD budget, annually spent in relation to 19,000 excess myocardial infarctions and strokes related to CKD.
The epidemiology of CKD in primary care is poorly studied. This is particularly the case in non-white populations who have an independent higher risk of progression to end stage renal failure (requiring dialysis or transplantation), CV events and death.
Further, CV disease risk in CKD remains poorly described beyond simple risk stratification by CKD stage. A recent systematic review identified some CKD-specific CV disease risk scores. However, all the risk scores had significant methodological limitations, such as a lack of external validation or the perception that they were not 'clinically useful'. The Leicester City and County Chronic Kidney Disease (LCC-CKD) cohort will be created from anonymised GP (general practice) records of individuals with CKD. We will aim to retrospectively create a cohort with 5 years follow-up to the present day. In addition, a present day cohort will be created to both aid research and provide data for practices and clinical commissioning groups for quality improvement (QI) purposes. We will aim to include 30,000 individuals with CKD in the cohort.
The principal objectives of the study are:
- To study the natural history of CKD in a multi-ethnic primary care setting
- To contribute to the creation of a risk prediction tool for heart attacks and strokes in CKD
The risk prediction tool would more accurately stratify risk of CV events for individuals with CKD. This would aid patients and clinicians in deciding on treatments aimed at reducing the risk of future myocardial infarctions and strokes. Currently, individuals with CKD, despite higher risk of CV disease, may not be receiving optimum treatment such as statins and anti-hypertensive medications. Improved management of cardiovascular risk factors in CKD is likely to see a reduction in CKD associated excess CV events and their associated costs, including longer average duration of inpatient admissions.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Leicestershire
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Leicester, Leicestershire, 영국, Le1 7rh
- University of Leicester
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Practice Level - all primary care practices within the 3 Clinical Commissioning Groups participating in the study.
- Patient Level - any individual 18 years or over with an MDRD (Modification of Diet in Renal Disease) or CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) eGFR (estimated glomerular filtration rate) less than 60ml/minute/1.73m2, proteinuria or a Read code CKD diagnosis.
Exclusion Criteria:
- Aged less than 18 years of age
- Endstage renal failure i.e. already receiving dialysis or with a kidney transplant.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cardiovascular disease events
기간: 5 years
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Major cardiovascular events, to study the natural history of CKD in a multi-ethic primary care setting and to contribute to the creation of a risk prediction tool for heart attacks and strokes in CKD
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5 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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모든 원인으로 인한 사망
기간: 5 년
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5 년
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Hospitalisation
기간: 5 years
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For individuals with CKD is associated with increased length of stay and therefore cost
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5 years
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
심혈관 질환에 대한 임상 시험
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University of Pennsylvania완전한Intrntl Classification of Diseases, 9th Revision, (ICD-9-CM) 410의 주진단 또는 이차진단 코드가 있는 환자(5번째 숫자가 2인 경우 제외)미국
다른에 대한 임상 시험
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Amsterdam University of Applied SciencesZonMw: The Netherlands Organisation for Health Research and Development; Amsterdam UMC모병