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Contrast Induced NephropathyREICIN-RESCINDNCT01402232

REduction of rIsk for Contrast Induced Nephropathy

An observational study of Contrast Induced Nephropathy, run by Guangdong Provincial People's Hospital at 12 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Contrast Induced Nephropathy
How many people
5,000 participants
Where
12 sitesChina
Study dates
Jan 2013to Nov 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: We reviewed all consecutive patients who were undergoing coronary angiography

Who may be able to join

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

Who cannot join

  • 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;
  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Guoliang Jia

    Dongguan, Guangdong, 510000

  • Jianfeng Ye

    Dongguan, Guangdong, 510000

  • Jian Qiu

    Guangzhou, Guangdong, 510000

  • Jingfeng Wang

    Guangzhou, Guangdong, 510000

  • Ken Wu

    Guangzhou, Guangdong, 510000

  • Yuqing Hou

    Guangzhou, Guangdong, 510000

  • Zhiming Du

    Guangzhou, Guangdong, 510000

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510100

  • Xiaoguang Zhou

    Kashgar, Xinjiang

  • Kaihong Chen

    Longyan, Fujian

  • Yan Liang

    Maoming, Guangdong, 510000

  • Guifu Wu

    Shenzhen, Guangdong

Other trials in China

About this study

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)

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.

Keywords
contrast-induced nephropathy, contrast medium, creatinine clearance, coronary angiography, diabetes, chronic kidney disease, predictive
Medical subject headings
Diabetes Mellitus, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01402232
Study groupRoleWhat they receive
coronary angiographyWe recruit all consecutive patients who were undergoing coronary angiography or percutaneous coronary intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 48-72 h

Secondary outcomes (6)

  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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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) .

    Measured: In-hospital

  6. Follow-up major adverse cardiovascular and clinical events

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

    Measured: >=1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2011 (estimated)
  2. Study startJan 2013
  3. Primary completionFeb 2016
  4. Study completionNov 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01402232
Sponsor's protocol ID
Y20110721
Acronym
REICIN-RESCIND
Status last verified
Aug 2018
First submitted
25 Jul 2011
Last updated
3 Aug 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Contrast Induced Nephropathy, run by Guangdong Provincial People's Hospital at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

contrast-induced nephropathy (time frame: 48-72 h). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01402232.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.

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