Risk Factors and Prognosis of Contrast-induced Acute Kidney Injury After Coronary Intervention
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|ClinicalTrials.gov Identifier: NCT04407936|
Recruitment Status : Active, not recruiting
First Posted : May 29, 2020
Last Update Posted : May 29, 2020
|Condition or disease|
|Contrast-Induced Acute Kidney Injury|
|Study Type :||Observational|
|Actual Enrollment :||89000 participants|
|Official Title:||Risk Factors and Prognosis of Contrast-induced Acute Kidney Injury After Coronary|
|Actual Study Start Date :||May 1, 2019|
|Actual Primary Completion Date :||May 1, 2019|
|Estimated Study Completion Date :||May 2021|
The investigators recruit all consecutive patients who were undergoing coronary angiography or percutaneous coronary intervention
- Contrast-Induced Acute Kidney Injury (CI-AKI) [ Time Frame: 48-72 hours ]Contrast-induced acute kidney injury was defined as a ≥ 0.5 mg/dL or 25 percent increase in serum creatinine from baseline during the first 48 to 72 hours after the procedure
- 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
- 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.
- 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: 1 year ]all-cause mortality (cardiovascular and noncardiovascular) and cardiovascular events.
- Follow-up major adverse cardiovascular and clinical events [ Time Frame: >=1 year ]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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407936
|Guangdong Provincial People's Hospital|
|Guangzhou, Guangdong, China, 510080|
|Study Director:||Liu Yong, MD,PhD||Guangdong Cardiovascular Institute,Guangdong Provincial People's Hospital|
|Study Director:||Shiqun Chen, MS||Guangdong Cardiovascular Institute,Guangdong Provincial People's Hospital|