Clinical trial NCT04407936: Risk Factors and Prognosis of Adverse Cardiovascular and Kidney Events After Coronary Intervention
Official title: Risk Factors and Prognosis of Adverse Cardiovascular and Kidney Events After Coronary Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardio-Renal Syndrome
Coronary Angiography
Coronary Artery Disease
Kidney Diseases
Metabolic Syndrome
Keywords: contrast-induced acute kidney injury
contrast medium
creatinine clearance
coronary angiography
chronic kidney disease
Adverse Cardiovascular and Kidney Events
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 88938
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators reviewed all consecutive patients who were undergoing coronary angiography

Brief summary: As a single center, retrospective observation study in Guangdong Institute of Cardiovascular Diseases, this study included the main study population of patients who underwent coronary angiography and / or coronary intervention from January 2007 to Decemeber 2018. The hospitalization information was collected in the form of direct derivation of the case, and cardiac and renal adverse events were collected through outpatient recorder system. All-cause death information was obtained from the Public Security and matched to the electronic Clinical Management System of the Guangdong Provincial People's Hospital records.

Detailed description: This is a single center, retrospective observation study collecting data on 88938 coronary angiography and / or coronary intervention patients from January 2007 to Decemeber 2018. Data regarding demographic information, admission diagnoses and history of present illness, biomarkers and details on preventive hydration and medications will be collected. The primary endpoint of this study is All-cause mortality, and secondary endpoints are Adverse Cardiovascular and Kidney Events.

Eligibility criteria: Inclusion Criteria:

1. Patients referred to CAG or PCI;

Exclusion Criteria:

-

Primary outcomes:
measure: All-cause mortality
timeFrame: From hospital admission to 13 years follow-up
Secondary outcomes:
measure: Contrast-Induced Acute Kidney Injury (CI-AKI 0.3)
timeFrame: 48 hours
measure: Cystatin C based CI-AKI (CI-AKI cyc)
timeFrame: 24-48 hours
measure: The change of eGFR, calculate based on CrCl and serum cystatin C
timeFrame: 48-72 hours
measure: Contrast-induced Persistent kidney injury (CI-PKI)
timeFrame: 3 months
measure: Incidence of major adverse cardiovascular events
timeFrame: 3-12months
measure: Follow-up major adverse cardiovascular and clinical events
timeFrame: 3-12months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Cardiovascular Institute,Guangdong Provincial People's Hospital
name: Liu Yong, MD,PhD
role: STUDY_DIRECTOR
affiliation: Guangdong Cardiovascular Institute,Guangdong Provincial People's Hospital
name: Shiqun Chen, MS
role: STUDY_DIRECTOR
References:
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