REICIN-RESCIND: REduction of rIsk for Contrast Induced Nephropathy

Sponsor

Guangdong Provincial People's Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01402232

Collaborator

First Affiliated Hospital, Sun Yat-Sen University (Other), Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other), Nanfang Hospital of Southern Medical University (Other), Guangzhou General Hospital of Guangzhou Military Command (Other), Guangdong Medical College (Other), Dongguan Kanghua Hospital (Other), Dongguan People's Hospital (Other), Maoming People's Hospital (Other), Futian People's Hospital (Other), Longyan City First Hospital (Other), First People's Hospital of Kashgar (Other)

5,000

Enrollment

Locations

Duration (Months)

416.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Feb 1, 2016

Anticipated Study Completion Date :

Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
coronary angiography We recruit all consecutive patients who were undergoing coronary angiography or percutaneous coronary intervention.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Fail to undergo CAG/PCI or die during the procedure；
End-stage renal diseases or renal replacement；
Pre-procedural unstable renal funciton (acute increase in serum creatinine more than 0.5mg/ml in the past 24 h)；
Intravascular administration of a contrast medium within the previous 48 hours；
Allergic to contrast medium;
Pregnancy, lactation or malignant tumoror life expectancy< 1 year;
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;
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaihong Chen	Longyan	Fujian	China
2	Guoliang Jia	Dongguan	Guangdong	China	510000
3	Jianfeng Ye	Dongguan	Guangdong	China	510000
4	Jian Qiu	Guangzhou	Guangdong	China	510000
5	Jingfeng Wang	Guangzhou	Guangdong	China	510000
6	Ken Wu	Guangzhou	Guangdong	China	510000
7	Yuqing Hou	Guangzhou	Guangdong	China	510000
8	Zhiming Du	Guangzhou	Guangdong	China	510000
9	Guangdong General Hospital	Guangzhou	Guangdong	China	510100
10	Yan Liang	Maoming	Guangdong	China	510000
11	Guifu Wu	Shenzhen	Guangdong	China
12	Xiaoguang Zhou	Kashi	Xinjiang	China

Investigators

Study Director: Yong Liu, MD,PhD, Guangdong Cardiovascular Institute,Guangdong General Hospital
Study Director: Shiqun Chen, MS, Guangdong Cardiovascular Institute,Guangdong General Hospital