Clinical trial NCT05050877: Risk Factors and Prognosis of Adverse Cardiovascular and Kidney Events After Coronary Intervention II
Official title: Risk Factors and Prognosis of Adverse Cardiovascular and Kidney Events After Coronary Intervention - Cardiorenal ImprovemeNt Registry II
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
Collaborators: name: First Affiliated Hospital of Fujian Medical University
name: Maoming Hospital Affiliated to Southern Medical University
name: Shenzhen People's Hospital
name: Yangjiang People's Hospital
First posted: 2021-09-21
Enrollment: 184855
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 multi-center, retrospective observation study in southern China, this study included the main study population of patients who underwent coronary angiography at 5 hospitals from Guangzhou, Shenzhen, Yangjiang, Maoming and Longyan from January 2000 to Decemeber 2020. The hospitalization information was collected in the form of direct derivation of the case, and cardiac and renal adverse events were collected through outpatient system. Data on all-cause death were obtained from the Guangdong Provincial Public Security and matched to the electronic Clinical Management System of the Guangdong Provincial People's Hospital records.

Detailed description: This is a multi-center, retrospective observation study collecting data on 184855 coronary angiography patients from January 2000 to Decemeber 2020. 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 Adverse Cardiovascular and Kidney Events.

Eligibility criteria: Inclusion Criteria:

1. Patients referred to CAG or PCI;

Exclusion Criteria:

-

Primary outcomes:
measure: Contrast-Induced Acute Kidney Injury (CI-AKI 0.3)
timeFrame: 48 hours
Secondary outcomes:
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
Other outcomes:
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
measure: All-cause mortality
timeFrame: From the hospital admission, and up to 10 years
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: Yong Liu, MD,PhD
role: STUDY_DIRECTOR
affiliation: Guangdong Cardiovascular Institute,Guangdong Provincial People's Hospital
name: Shiqun Chen, MS
role: STUDY_DIRECTOR
References: