NCT01402232

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

3.1 years

First QC Date

July 25, 2011

Last Update Submit

August 1, 2018

Conditions

Keywords

contrast-induced nephropathycontrast mediumcreatinine clearancecoronary angiographydiabeteschronic kidney diseasepredictive

Outcome Measures

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.

    48-72 h

Secondary Outcomes (6)

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

    48h

  • Cystatin C based CI-AKI (CI-AKIcyc)

    24-48h

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

    48-72 h

  • Persistent CI-AKI (CI-AKIp)

    3 months

  • In-hospital major adverse cardiovascular and clinical events

    In-hospital

  • +1 more secondary outcomes

Study Arms (1)

coronary angiography

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We reviewed all consecutive patients who were undergoing coronary angiography

You may qualify if:

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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Kaihong Chen

Longyan, Fujian, China

Location

Guoliang Jia

Dongguan, Guangdong, 510000, China

Location

Jianfeng Ye

Dongguan, Guangdong, 510000, China

Location

Jian Qiu

Guangzhou, Guangdong, 510000, China

Location

Jingfeng Wang

Guangzhou, Guangdong, 510000, China

Location

Ken Wu

Guangzhou, Guangdong, 510000, China

Location

Yuqing Hou

Guangzhou, Guangdong, 510000, China

Location

Zhiming Du

Guangzhou, Guangdong, 510000, China

Location

Guangdong General Hospital

Guangzhou, Guangdong, 510100, China

Location

Yan Liang

Maoming, Guangdong, 510000, China

Location

Guifu Wu

Shenzhen, Guangdong, China

Location

Xiaoguang Zhou

Kashgar, Xinjiang, China

Location

MeSH Terms

Conditions

Diabetes MellitusRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yong Liu, MD,PhD

    Guangdong Cardiovascular Institute,Guangdong General Hospital

    STUDY DIRECTOR
  • Shiqun Chen, MS

    Guangdong Cardiovascular Institute,Guangdong General Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 25, 2011

First Posted

July 26, 2011

Study Start

January 1, 2013

Primary Completion

February 1, 2016

Study Completion

November 1, 2018

Last Updated

August 3, 2018

Record last verified: 2018-08

Locations