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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05050877
Enrollment
184855
Registered
2021-09-21
Start date
2000-06-01
Completion date
2020-12-31
Last updated
2021-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

contrast-induced acute kidney injury, contrast medium, creatinine clearance, coronary angiography, chronic kidney disease, Adverse Cardiovascular and Kidney Events

Brief 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.

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.

Interventions

None listed

Sponsors

First Affiliated Hospital of Fujian Medical University
CollaboratorOTHER
Maoming Hospital Affiliated to Southern Medical University
CollaboratorUNKNOWN
Shenzhen People's Hospital
CollaboratorOTHER
Yangjiang People's Hospital
CollaboratorOTHER
Guangdong Provincial People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1\. Patients referred to CAG or PCI;

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Contrast-Induced Acute Kidney Injury (CI-AKI 0.3)48 hoursdefined as a ≥ 0.3 mg/dL absolute increase in serum creatinine from baseline during the first 48 hours after the procedure

Secondary

MeasureTime frameDescription
Cystatin C based CI-AKI (CI-AKI cyc)24-48 hoursCystatin 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.
The change of eGFR, calculate based on CrCl and serum cystatin C48-72 hoursThe 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.

Other

MeasureTime frameDescription
All-cause mortalityFrom the hospital admission, and up to 10 yearsDied for any reason
Follow-up major adverse cardiovascular and clinical events3-12monthsWe will follow up the patients by telephone and outpatient service to know the one year all-cause mortality (cardiovascular and noncardiovascular) and cardiovascular events.
Contrast-induced Persistent kidney injury (CI-PKI)3 monthsSerum 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.
Incidence of major adverse cardiovascular events3-12monthsall-cause mortality (cardiovascular and noncardiovascular) and cardiovascular events.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026