REduction of rIsk for Contrast Induced Nephropathy (REICIN-RESCIND)

August 1, 2018 updated by: Jiyan Chen, Guangdong Provincial People's Hospital

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

We reviewed all consecutive patients who were undergoing coronary angiography

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
coronary angiography
We recruit all consecutive patients who were undergoing coronary angiography or percutaneous coronary intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
contrast-induced nephropathy
Time Frame: 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.
48-72 h

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
contrast-induced acute kidney injury (CI-AKI0.3)
Time Frame: 48h
defined as a ≥ 0.3 mg/dL absolute increase in serum creatinine from baseline during the first 48 hours after the procedure
48h
Cystatin C based CI-AKI (CI-AKIcyc)
Time Frame: 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.
24-48h
The change of eGFR, calculate based on CrCl and serum cystatin C
Time Frame: 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.
48-72 h
Persistent CI-AKI (CI-AKIp)
Time Frame: 3 months
defined as residual impairment of renal function indicated by a ≥ 25% reduction in creatinine clearance at 3 months in comparison with baseline.
3 months
In-hospital major adverse cardiovascular and clinical events
Time Frame: 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) .
In-hospital
Follow-up major adverse cardiovascular and clinical events
Time Frame: >=1 year
all-cause mortality, RRT, re-hospitalization, cardiovascular events, cerebrovascular events, and bleeding.
>=1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangdong Provincial People's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
First Affiliated Hospital, Sun Yat-Sen University
Nanfang Hospital of Southern Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Dongguan People's Hospital
Guangzhou General Hospital of Guangzhou Military Command
Guangdong Medical College
Dongguan Kanghua Hospital
Longyan City First Hospital
Maoming People's Hospital
Futian People's Hospital
First People's Hospital of Kashgar

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yong Liu, MD,PhD, Guangdong Cardiovascular Institute,Guangdong General Hospital
  • Study Director: Shiqun Chen, MS, Guangdong Cardiovascular Institute,Guangdong General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Y20110721

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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