MedPath

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

Completed
Conditions
Kidney Diseases
Coronary Angiography
Coronary Artery Disease
Metabolic Syndrome
Cardio-Renal Syndrome
Registration Number
NCT04407936
Lead Sponsor
Guangdong Provincial People's Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
88938
Inclusion Criteria
  1. Patients referred to CAG or PCI;
Exclusion Criteria

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
All-cause mortalityFrom hospital admission to 13 years follow-up

Admission Patients Died for all-cause mortality within 13 years.

Secondary Outcome Measures
NameTimeMethod
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

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

The change of eGFR, calculate based on CrCl and serum cystatin C48-72 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.

Contrast-induced Persistent kidney injury (CI-PKI)3 months

Serum creatinine was measured by endpoint colorimetry or enzymatic assays. CI-PKI was defined as residual impairment of renal function indicated by a ≥ 25% reduction in creatinine clearance at 3 months in comparison with baseline. comparison with baseline

Incidence of major adverse cardiovascular events3-12months

all-cause mortality (cardiovascular and noncardiovascular) and cardiovascular events.

Follow-up major adverse cardiovascular and clinical events3-12months

We will follow up the patients by telephone and outpatient service to know the one year all-cause mortality (cardiovascular and noncardiovascular) and cardiovascular events.

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital

🇨🇳

Guangzhou, Guangdong, China

© Copyright 2025. All Rights Reserved by MedPath