Clinical trial NCT02808845: Microalbuminuria Predicting CIAKI After CAG
Official title: Pre-existing Microalbuminuria Predicting Contrast-induced Acute Kidney Injury (CIAKI) Following Coronary Angiography (CAG)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Contrast-induced Acute Kidney Injury
Microalbuminuria
Keywords: coronary angiography
contrast-induced acute kidney injury
microalbuminuria
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: changes of serum creatinine (SCr, umol/L)
timeFrame: 24-48 hours after CAG
measure: number of participants with increase in SCr of at least 44.2 umol/L higher than before
timeFrame: 24-48 hours after CAG
measure: number of participants with increase of SCr over 25% higher than before
timeFrame: 24-48 hours after CAG
Secondary outcomes:
measure: changes of urine albumin to creatinine ratio (ACR, mg/g)
timeFrame: 24-48 hours after CAG
Other outcomes:
Locations:
city: Nanjing
country: China
facility: First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
name: Zhijian Yang, Doctor
role: STUDY_CHAIR
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