REduction of rIsk for Contrast Induced Nephropathy (REICIN-RESCIND)

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)

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.

Study Overview

• Status: Unknown
• Conditions: Contrast Induced Nephropathy

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 Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

Study Locations

• China
  • Fujian
    • Longyan, Fujian, China
      • Kaihong Chen
  • Guangdong
    • Dongguan, Guangdong, China, 510000
      • Guoliang Jia
    • Dongguan, Guangdong, China, 510000
      • Jianfeng Ye
    • Guangzhou, Guangdong, China, 510100
      • Guangdong General Hospital
    • Guangzhou, Guangdong, China, 510000
      • Jian Qiu
    • Guangzhou, Guangdong, China, 510000
      • Jingfeng Wang
    • Guangzhou, Guangdong, China, 510000
      • Ken Wu
    • Guangzhou, Guangdong, China, 510000
      • Yuqing Hou
    • Guangzhou, Guangdong, China, 510000
      • Zhiming Du
    • Maoming, Guangdong, China, 510000
      • Yan Liang
    • Shenzhen, Guangdong, China
      • Guifu Wu
  • Xinjiang
    • Kashi, Xinjiang, China
      • Xiaoguang Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

We reviewed all consecutive patients who were undergoing coronary angiography

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
coronary angiography; We recruit all consecutive patients who were undergoing coronary angiography or percutaneous coronary intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48-72 h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	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) .	In-hospital
Follow-up major adverse cardiovascular and clinical events	all-cause mortality, RRT, re-hospitalization, cardiovascular events, cerebrovascular events, and bleeding.	>=1 year

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Nanfang Hospital of Southern Medical University; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; Dongguan People's Hospital; Guangzhou General Hospital of Guangzhou Military Command; Guangdong Medical College; Dongguan Kanghua Hospital; Longyan City First Hospital; Maoming People's Hospital; Futian People's Hospital; First People's Hospital of Kashgar
• Investigators: Study Director: Yong Liu, MD,PhD, Guangdong Cardiovascular Institute,Guangdong General Hospital; Study Director: Shiqun Chen, MS, Guangdong Cardiovascular Institute,Guangdong General Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ANTICIPATED): November 1, 2018

Study Registration Dates

• First Submitted: July 25, 2011
• First Submitted That Met QC Criteria: July 25, 2011
• First Posted (ESTIMATE): July 26, 2011

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: diabetes; chronic kidney disease; coronary angiography; contrast-induced nephropathy; creatinine clearance; contrast medium; predictive
• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: Y20110721