Microalbuminuria Predicting CIAKI After CAG (MPCC)

June 21, 2016 updated by: The First Affiliated Hospital with Nanjing Medical University

Pre-existing Microalbuminuria Predicting Contrast-induced Acute Kidney Injury (CIAKI) Following Coronary Angiography (CAG)

The purpose of this study is to investigate the association between pre-existing microalbuminuria and contrast-induced acute kidney injury (CIAKI) following coronary angiography (CAG).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

800

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
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • First Affiliated Hospital of Nanjing Medical University

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with eGFR ≥ 30 ml/min and without macroalbuminuria (defined as urine albumin to creatinine ratio (ACR) >300 mg/g) on admission are prepared to accept scheduled invasive coronary angiography during hospitalization.

Description

Inclusion Criteria:

  • Patients with eGFR≥30ml/min and without macroalbuminuria undergoing CAG.

Exclusion Criteria:

  • Pregnancy
  • Lactation
  • Allergic history of contrast media
  • Having been received contrast media within 7 days
  • Use of nephrotoxic medications within 7 days
  • eGFR <30 ml/min, macroalbuminuria (ACR >300 mg/g)
  • Renal transplantation, emergent coronary angiography
  • Cardiogenic shock, pulmonary edema
  • Use of intra-aortic balloon pump (IABP) or mechanical ventilation
  • Multiple myeloma and other malignant tumor
  • Life expectancy less than 12 months

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
Intervention / Treatment
microalbuminuria with eGFR≥60ml/min
microalbuminuria group with estimated glomerular filtration rate (eGFR) ≥60ml/min.
Other: microalbuminuria
normal-albuminuria group with eGFR≥60ml/min
normal-albuminuria group with estimated glomerular filtration rate (eGFR) ≥60ml/min.
microalbuminuria group with eGFR<60ml/min
microalbuminuria group with estimated glomerular filtration rate (eGFR) <60ml/min.
Other: microalbuminuria
normal-albuminuria group with eGFR<60ml/min
normal-albuminuria group with estimated glomerular filtration rate (eGFR) <60ml/min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes of serum creatinine (SCr, umol/L)
Time Frame: 24-48 hours after CAG
the difference of SCr before and after CAG.
24-48 hours after CAG
number of participants with increase in SCr of at least 44.2 umol/L higher than before
Time Frame: 24-48 hours after CAG
number of participants with the difference of SCr before and after CAG over 44.2 umol/L.
24-48 hours after CAG
number of participants with increase of SCr over 25% higher than before
Time Frame: 24-48 hours after CAG
number of participants with an increase of SCr over 25% higher than before.
24-48 hours after CAG

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes of urine albumin to creatinine ratio (ACR, mg/g)
Time Frame: 24-48 hours after CAG
the difference of ACR before and after CAG
24-48 hours after CAG

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Study Chair: Zhijian Yang, Doctor, First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

December 1, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

June 13, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimate)

June 22, 2016

Study Record Updates

Last Update Posted (Estimate)

June 22, 2016

Last Update Submitted That Met QC Criteria

June 21, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIAKI-1

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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