REduction of rIsk for Contrast Induced Nephropathy

Guangdong Provincial People's Hospital5,000 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

5,000

Conditions

Contrast Induced Nephropathy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (12)

Kaihong Chen

Longyan, Fujian, China

Guoliang Jia

Dongguan, Guangdong, China

Jianfeng Ye

Dongguan, Guangdong, China

Jian Qiu

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

contrast-induced nephropathy

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.

Time frame: 48-72 h

Secondary Outcomes

contrast-induced acute kidney injury (CI-AKI0.3)

defined as a ≥ 0.3 mg/dL absolute increase in serum creatinine from baseline during the first 48 hours after the procedure

Time frame: 48h

Cystatin C based CI-AKI (CI-AKIcyc)

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.

Time frame: 24-48h

The change of eGFR, calculate based on CrCl and serum cystatin C

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.

Time frame: 48-72 h

Persistent CI-AKI (CI-AKIp)

defined as residual impairment of renal function indicated by a ≥ 25% reduction in creatinine clearance at 3 months in comparison with baseline.

Time frame: 3 months

In-hospital major adverse cardiovascular and clinical events

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) .

Data from ClinicalTrials.gov

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