Risk Factors and Prognosis of Adverse Cardiovascular and Kidney Events After Coronary Intervention II

Completed

• Conditions: Kidney Diseases; Cardio-Renal Syndrome; Coronary Angiography; Coronary Artery Disease; Metabolic Syndrome

• Registration Number: NCT05050877
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Study Timeline

• Study Start: 2000-06-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-09
• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-10
• Last Update Submitted: 2021-09-10
• Study First Posted: 2021-09-21
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184855

Inclusion Criteria

1. Patients referred to CAG or PCI;

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Contrast-Induced Acute Kidney Injury (CI-AKI 0.3)	48 hours	defined as a ≥ 0.3 mg/dL absolute increase in serum creatinine from baseline during the first 48 hours after the procedure

Secondary Outcome Measures

Name	Time	Method
The change of eGFR, calculate based on CrCl and serum cystatin C	48-72 hours	The eGFR creatinine-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.
Cystatin C based CI-AKI (CI-AKI cyc)	24-48 hours	Cystatin C based CI-AKI, 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.mg/dL absolute increase in serum creatinine from baseline during the first 48 hours after the procedure.

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China