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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04407936
• Other study ID #: GDREC2019555H
• Status: Completed
• 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
• 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: -

Related Conditions & MeSH terms

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

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