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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05050877
Other study ID # 2019-555H-2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2000
Est. completion date December 31, 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 184855
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
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 (5)

Lead Sponsor Collaborator
Guangdong Provincial People's Hospital First Affiliated Hospital of Fujian Medical University, Maoming Hospital Affiliated to Southern Medical University, Shenzhen People's Hospital, Yangjiang People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other Incidence of major adverse cardiovascular events all-cause mortality (cardiovascular and noncardiovascular) and cardiovascular events. 3-12months
Other 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
Other All-cause mortality Died for any reason From the hospital admission, and up to 10 years
Primary 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
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