REduction of rIsk for Contrast Induced Nephropathy

NCT ID: NCT01402232

Last Updated: 2018-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2018-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Contrast Induced Nephropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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coronary angiography

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role collaborator

Guangzhou General Hospital of Guangzhou Military Command

OTHER

Sponsor Role collaborator

Guangdong Medical College

OTHER

Sponsor Role collaborator

Dongguan Kanghua Hospital

OTHER

Sponsor Role collaborator

Dongguan People's Hospital

OTHER_GOV

Sponsor Role collaborator

Maoming People's Hospital

OTHER

Sponsor Role collaborator

Futian People's Hospital

OTHER

Sponsor Role collaborator

Longyan City First Hospital

OTHER

Sponsor Role collaborator

First People's Hospital of Kashgar

UNKNOWN

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jiyan Chen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yong Liu, MD,PhD

Role: STUDY_DIRECTOR

Guangdong Cardiovascular Institute,Guangdong General Hospital

Shiqun Chen, MS

Role: STUDY_DIRECTOR

Guangdong Cardiovascular Institute,Guangdong General Hospital

Locations

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Kaihong Chen

Longyan, Fujian, China

Site Status

Guoliang Jia

Dongguan, Guangdong, China

Site Status

Jianfeng Ye

Dongguan, Guangdong, China

Site Status

Jian Qiu

Guangzhou, Guangdong, China

Site Status

Jingfeng Wang

Guangzhou, Guangdong, China

Site Status

Ken Wu

Guangzhou, Guangdong, China

Site Status

Yuqing Hou

Guangzhou, Guangdong, China

Site Status

Zhiming Du

Guangzhou, Guangdong, China

Site Status

Guangdong General Hospital

Guangzhou, Guangdong, China

Site Status

Yan Liang

Maoming, Guangdong, China

Site Status

Guifu Wu

Shenzhen, Guangdong, China

Site Status

Xiaoguang Zhou

Kashgar, Xinjiang, China

Site Status

Countries

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China

Other Identifiers

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Y20110721

Identifier Type: -

Identifier Source: org_study_id

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