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

Coronary Artery Disease Clinical Trial

Official title:

Risk Factors and Prognosis of Adverse Cardiovascular and Kidney Events After Coronary Intervention - Cardiorenal ImprovemeNt Registry II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05050877
• Other study ID #: 2019-555H-2
• Status: Completed
• 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
• 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: -

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 (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