Completed

NCT Number: NCT05050877

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

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Key information

Conditions

Cardio-Renal Syndrome Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chronic Disease Coronary Angiography Coronary Artery Disease Coronary Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Heart Diseases Heart Failure Hyperinsulinism Insulin Resistance Kidney Diseases Male Urogenital Diseases Metabolic Diseases Metabolic Syndrome Myocardial Ischemia Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients referred to CAG or PCI;

Exclusion criteria

Treatment and study plan

Primary outcomes

Contrast-Induced Acute Kidney Injury (CI-AKI 0.3)

Time frame: 48 hours

defined as a ≥ 0.3 mg/dL absolute increase in serum creatinine from baseline during the first 48 hours after the procedure

Secondary outcomes

Cystatin C based CI-AKI (CI-AKI cyc)

Time frame: 24-48 hours

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.
The change of eGFR, calculate based on CrCl and serum cystatin C

Time frame: 48-72 hours

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.

Other outcomes

Contrast-induced Persistent kidney injury (CI-PKI)

Time frame: 3 months

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.
Incidence of major adverse cardiovascular events

Time frame: 3-12months

all-cause mortality (cardiovascular and noncardiovascular) and cardiovascular events.
Follow-up major adverse cardiovascular and clinical events

Time frame: 3-12months

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.
All-cause mortality

Time frame: From the hospital admission, and up to 10 years

Died for any reason

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Collaborators

First Affiliated Hospital of Fujian Medical University
Maoming Hospital Affiliated to Southern Medical University
Shenzhen People's Hospital
Yangjiang People's Hospital

Registry information

Official study title

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

Important dates

Study start: 2000
Primary completion: 2020
Study completion: 2020
First posted: Sep 21, 2021
Registry last updated: Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed