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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Kidney Diseases; Metabolic Syndrome; Cardio-Renal Syndrome; Coronary Angiography

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 184855

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The investigators reviewed all consecutive patients who were undergoing coronary angiography.

Description

Inclusion Criteria:

1. Patients referred to CAG or PCI;

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
coronary angiography; The investigators recruit all consecutive patients who were undergoing coronary angiography or percutaneous coronary intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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/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.	48-72 hours

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Collaborators: First Affiliated Hospital of Fujian Medical University; Shenzhen People's Hospital; Maoming Hospital Affiliated to Southern Medical University; Yangjiang People's Hospital
• Investigators: Study Director: Yong Liu, MD,PhD, Guangdong Cardiovascular Institute,Guangdong Provincial People's Hospital; Study Director: Shiqun Chen, MS, Guangdong Cardiovascular Institute,Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2000
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: chronic kidney disease; coronary angiography; contrast-induced acute kidney injury; creatinine clearance; contrast medium; Adverse Cardiovascular and Kidney Events
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Urologic Diseases; Disease; Renal Insufficiency; Insulin Resistance; Hyperinsulinism; Coronary Disease; Heart Failure; Coronary Artery Disease; Syndrome; Kidney Diseases; Metabolic Syndrome; Cardio-Renal Syndrome
• Other Study ID Numbers: 2019-555H-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED