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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04407936
Other study ID # GDREC2019555H
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2007
Est. completion date March 10, 2020

Study information

Verified date September 2021
Source Guangdong Provincial People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 88938
Est. completion date March 10, 2020
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Patients referred to CAG or PCI; Exclusion Criteria: -

Study Design


Locations

Country Name City State
China Guangdong Provincial People's Hospital Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause mortality Admission Patients Died for all-cause mortality within 13 years. From hospital admission to 13 years follow-up
Secondary Contrast-Induced Acute Kidney Injury (CI-AKI 0.3) defined as a = 0.3 mg/dL absolute increase in serum creatinine from baseline during the first 48 hours after the procedure 48 hours
Secondary Cystatin C based CI-AKI (CI-AKI cyc) 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 24-48 hours
Secondary The change of eGFR, calculate based on CrCl and serum cystatin C The eGFR creatinine-cystatin C was calculated by the 2012 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin C equation: 135 *min(Scr/?, 1)a * max(Scr/?, 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, ? is 0.7 for females and 0.9 for males, a is -0.248 for females and -0.207 for males, min indicates the minimum of Scr/? or 1, and max indicates the maximum of Scr/? or 1. 48-72 hours
Secondary Contrast-induced Persistent kidney injury (CI-PKI) 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 3 months
Secondary Incidence of major adverse cardiovascular events all-cause mortality (cardiovascular and noncardiovascular) and cardiovascular events. 3-12months
Secondary Follow-up major adverse cardiovascular and clinical events 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. 3-12months
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