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Status unknownNCT01402232REICIN-RESCINDUpdated Aug 3, 2018

REduction of rIsk for Contrast Induced Nephropathy

An observational study in Contrast Induced Nephropathy, sponsored by Guangdong Provincial People's Hospital. Status unknown at 12 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-03.

Sponsored by Guangdong Provincial People's Hospital · Observational

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Contrast Induced Nephropathy

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Keywords

  • contrast-induced nephropathy
  • contrast medium
  • creatinine clearance
  • coronary angiography
  • diabetes
  • chronic kidney disease
  • predictive
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Guangdong Provincial People's Hospital is the lead sponsor of 231 studies on the registry; 101 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

We reviewed all consecutive patients who were undergoing coronary angiography

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

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)

Groups and cohorts

  • coronary angiography

    We recruit all consecutive patients who were undergoing coronary angiography or percutaneous coronary intervention.

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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) .

    Time frame: In-hospital

  6. Follow-up major adverse cardiovascular and clinical events

    all-cause mortality, RRT, re-hospitalization, cardiovascular events, cerebrovascular events, and bleeding.

    Time frame: >=1 year

07

Study locations

12 sites
  • Kaihong Chen
    Longyan, Fujian, China
  • Guoliang Jia
    Dongguan, Guangdong 510000, China
  • Jianfeng Ye
    Dongguan, Guangdong 510000, China
  • Jian Qiu
    Guangzhou, Guangdong 510000, China
  • Jingfeng Wang
    Guangzhou, Guangdong 510000, China
  • Ken Wu
    Guangzhou, Guangdong 510000, China
  • Yuqing Hou
    Guangzhou, Guangdong 510000, China
  • Zhiming Du
    Guangzhou, Guangdong 510000, China
  • Guangdong General Hospital
    Guangzhou, Guangdong 510100, China
  • Yan Liang
    Maoming, Guangdong 510000, China
  • Guifu Wu
    Shenzhen, Guangdong, China
  • Xiaoguang Zhou
    Kashi, Xinjiang, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01402232
Lead sponsor
Guangdong Provincial People's Hospital
Collaborators
First Affiliated Hospital, Sun Yat-Sen University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Nanfang Hospital, Southern Medical University, Guangzhou General Hospital of Guangzhou Military Command, Guangdong Medical College, Dongguan Kanghua Hospital, Dongguan People's Hospital, Maoming People's Hospital, Futian People's Hospital, Longyan City First Hospital, First People's Hospital of Kashgar
Responsible party
Jiyan Chen (MD, Guangdong Provincial People's Hospital) — Principal investigator
First posted
Jul 26, 2011
Start date
Jan 2013
Primary completion
Feb 2016
Completion
Nov 2018 (estimated)
Last update
Aug 3, 2018

Study contacts

Yong Liu, MD,PhD
study director · Guangdong Cardiovascular Institute,Guangdong General Hospital
Shiqun Chen, MS
study director · Guangdong Cardiovascular Institute,Guangdong General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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