Clinical trial NCT01402232: REduction of rIsk for Contrast Induced Nephropathy
Official title: REduction of rIsk for Contrast-Induced Nephropathy (REICIN) Study:RESCIND-P (Prospective Observational Study for REduction of contraSt-induced Nephropathy and Cardiaovascular Events followINg carDiac Catheterization)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Contrast Induced Nephropathy
Keywords: contrast-induced nephropathy
contrast medium
creatinine clearance
coronary angiography
diabetes
chronic kidney disease
predictive
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Nanfang Hospital, Southern Medical University
name: Guangzhou General Hospital of Guangzhou Military Command
name: Guangdong Medical College
name: Dongguan Kanghua Hospital
name: Dongguan People's Hospital
name: Maoming People's Hospital
name: Futian People's Hospital
name: Longyan City First Hospital
name: First People's Hospital of Kashgar
First posted: 2011-07-26
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We reviewed all consecutive patients who were undergoing coronary angiography

Brief summary: The REduction of rIsk for Contrast-Induced Nephropathy (REICIN) study is the largest prospective multicenter data base for CIN flowing coronary angiography (CAG) or percutaneous coronary intervention (PCI). The REICIN study has the potential to characterize contemporary CIN incidence, modified risk factors and prognosis, so that to identify strategiaes to reduce risk of CIN following CAG/PCI.

Detailed description: This is a multicenter prospective observational study collecting data on over 5000 CAG patients admitted to department of cardiology in 12 hospitals from January 2013. Data will be collected for more than 1 year on all patients undergoing CAG with or without PCI older than 18 years without baseline end-stage renal failure needing renal replacement therapy or renal transplantation. Data to be collected includes demographic information, admission diagnoses and co-morbidities, biomarkers and details on preventive hydration and medications used Contrast-induced nephropathy (CIN) is the primary endpoint, defined as a ≥ 0.5 mg/dL or 25% increase in serum creatinine (SCr) from baseline during the first 48 to 72 hours after the procedure.

Eligibility criteria: Inclusion Criteria:

1. Patients referred to CAG or PCI;
2. Age ≥ 18 years
3. Submit informed consent and adhere to the study protocol

Exclusion Criteria:

1. Fail to undergo CAG/PCI or die during the procedure；
2. End-stage renal diseases or renal replacement；
3. Pre-procedural unstable renal funciton (acute increase in serum creatinine more than 0.5mg/ml in the past 24 h)；
4. Intravascular administration of a contrast medium within the previous 48 hours；
5. Allergic to contrast medium;
6. Pregnancy, lactation or malignant tumoror life expectancy\< 1 year;
7. The use of renal toxicity drugs (non-steroidal anti-inflammatory drugs, aminoglycoside drugs, cyclosporine, cisplatin etc) within 48 h before cardiac catheter surgery and the whole process of the research;
8. Refer to receive renal artery angiography or surgical valve replacement in patients with rheumatic heart disease； For exclusion creteria 7, patients admited and taked aspirin are included in the study.

Primary outcomes:
measure: contrast-induced nephropathy
timeFrame: 48-72 h
Secondary outcomes:
measure: contrast-induced acute kidney injury (CI-AKI0.3)
timeFrame: 48h
measure: Cystatin C based CI-AKI (CI-AKIcyc)
timeFrame: 24-48h
measure: The change of eGFR, calculate based on CrCl and serum cystatin C
timeFrame: 48-72 h
measure: Persistent CI-AKI (CI-AKIp)
timeFrame: 3 months
measure: In-hospital major adverse cardiovascular and clinical events
timeFrame: In-hospital
measure: Follow-up major adverse cardiovascular and clinical events
timeFrame: >=1 year
Other outcomes:
Locations:
city: Longyan
country: China
facility: Kaihong Chen
state: Fujian
city: Dongguan
country: China
facility: Guoliang Jia
state: Guangdong
city: Dongguan
country: China
facility: Jianfeng Ye
state: Guangdong
city: Guangzhou
country: China
facility: Jian Qiu
state: Guangdong
city: Guangzhou
country: China
facility: Jingfeng Wang
state: Guangdong
city: Guangzhou
country: China
facility: Ken Wu
state: Guangdong
city: Guangzhou
country: China
facility: Yuqing Hou
state: Guangdong
city: Guangzhou
country: China
facility: Zhiming Du
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Maoming
country: China
facility: Yan Liang
state: Guangdong
city: Shenzhen
country: China
facility: Guifu Wu
state: Guangdong
city: Kashi
country: China
facility: Xiaoguang Zhou
state: Xinjiang
Study officials:
affiliation: Guangdong Cardiovascular Institute,Guangdong General Hospital
name: Yong Liu, MD,PhD
role: STUDY_DIRECTOR
affiliation: Guangdong Cardiovascular Institute,Guangdong General Hospital
name: Shiqun Chen, MS
role: STUDY_DIRECTOR
References: