REduction of rIsk for Contrast Induced Nephropathy

• Conditions: Contrast Induced Nephropathy

• Registration Number: NCT01402232
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Study Timeline

• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Study Start: 2013-01
• Primary Completion: 2016-02
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-03
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
contrast-induced nephropathy	48-72 h	Contrast-Induced Nephropathy was defined as a ≥ 0.5 mg/dL or 25% increase in serum creatinine from baseline during the first 48 to 72 hours after the procedure.

Secondary Outcome Measures

Name	Time	Method
contrast-induced acute kidney injury (CI-AKI0.3)	48h	defined as a ≥ 0.3 mg/dL absolute increase in serum creatinine from baseline during the first 48 hours after the procedure
Cystatin C based CI-AKI (CI-AKIcyc)	24-48h	defined as a ≥10% absolute increase in serum cystatin C during the first 24 hours after the procedure and and a ≥ 0.3 mg/dL absolute increase in serum creatinine from baseline during the first 48 hours after the procedure.
The change of eGFR, calculate based on CrCl and serum cystatin C	48-72 h	The eGFRcreatinine-cystatin C was calculated by the 2012 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin C equation: 135 × min(Scr/κ, 1)α × max(Scr/κ, 1)-0.601 × min(Scys/0.8, 1)-0.375 × max (Scys/0.8, 1)-0.711 × 0.995Age \[× 0.969 if female\] \[× 1.08 if black\], where Scr is serum creatinine, Scys is serum cystatin C, κ is 0.7 for females and 0.9 for males, α is -0.248 for females and -0.207 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1.
Persistent CI-AKI (CI-AKIp)	3 months	defined as residual impairment of renal function indicated by a ≥ 25% reduction in creatinine clearance at 3 months in comparison with baseline.
In-hospital major adverse cardiovascular and clinical events	In-hospital	all-cause mortality (cardiovascular and noncardiovascular), required renal replacement therapy (RRT), cardiovascular events (acute myocardial infarction, acute heart failure，cardiac shock, heart/ventricular septal rupture,clinical arrhythmia), Cerebrovascular events (Stroke), and bleeding (TIMI grade) .
Follow-up major adverse cardiovascular and clinical events	>=1 year	all-cause mortality, RRT, re-hospitalization, cardiovascular events, cerebrovascular events, and bleeding.

Trial Locations

Locations (12)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China

Yan Liang; 🇨🇳 Maoming, Guangdong, China

Guifu Wu; 🇨🇳 Shenzhen, Guangdong, China

Jingfeng Wang; 🇨🇳 Guangzhou, Guangdong, China

Zhiming Du; 🇨🇳 Guangzhou, Guangdong, China

Guoliang Jia; 🇨🇳 Dongguan, Guangdong, China

Yuqing Hou; 🇨🇳 Guangzhou, Guangdong, China

Ken Wu; 🇨🇳 Guangzhou, Guangdong, China

Kaihong Chen; 🇨🇳 Longyan, Fujian, China

Jianfeng Ye; 🇨🇳 Dongguan, Guangdong, China

Jian Qiu; 🇨🇳 Guangzhou, Guangdong, China

Xiaoguang Zhou; 🇨🇳 Kashi, Xinjiang, China