REduction of rIsk for Contrast Induced Nephropathy

Contrast Induced Nephropathy Clinical Trial

— REICIN-RESCIND  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01402232
• Other study ID #: Y20110721
• Status: Active, not recruiting
• Start date: January 2013
• Est. completion date: November 2018

Study information

• Verified date: August 2018
• Source: Guangdong General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: November 2018
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Contrast Induced Nephropathy
• Kidney Diseases

Locations

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

Sponsors (12)

Lead Sponsor

Collaborator

Guangdong General Hospital

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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/?, 1)a × max(Scr/?, 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, ? is 0.7 for females and 0.9 for males, a is -0.248 for females and -0.207 for males, min indicates the minimum of Scr/? or 1, and max indicates the maximum of Scr/? or 1.	48-72 h
Secondary	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
Secondary	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
Secondary	Follow-up major adverse cardiovascular and clinical events	all-cause mortality, RRT, re-hospitalization, cardiovascular events, cerebrovascular events, and bleeding.	>=1 year