Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Risk Factors and Prognosis of Contrast-induced Acute Kidney Injury After Coronary Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04407936
Recruitment Status : Active, not recruiting
First Posted : May 29, 2020
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Jiyan Chen, Guangdong Provincial People's Hospital

Brief Summary:
As a single center, retrospective observation study in Guangdong Institute of Cardiovascular Diseases, this study included the main study population of patients who underwent coronary angiography and / or coronary intervention from 2000 to 2019. The hospitalization information was collected in the form of direct derivation of the case, and the follow-up information was collected through outpatient service and telephone follow-up.

Condition or disease
Contrast-Induced Acute Kidney Injury

Detailed Description:
This is a single center, retrospective observation study collecting data on 89000 coronary angiography and / or coronary intervention patients from 2000 to 2019.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 Contrast-induced acute kidney injury (CI-AKI), defined as a ≥ 0.5 mg/dL or 25% increase in serum creatinine (SCr) from baseline during the first 48 to 72 hours after the procedure.

Layout table for study information
Study Type : Observational
Actual Enrollment : 89000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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

  5. Incidence of major adverse cardiovascular events [ Time Frame: 1 year ]
    all-cause mortality (cardiovascular and noncardiovascular) and cardiovascular events.

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The investigators reviewed all consecutive patients who were undergoing coronary angiography
Criteria

Inclusion Criteria:

  1. Patients referred to CAG or PCI;
  2. Age ≥ 18 years

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407936


Locations
Layout table for location information
China, Guangdong
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Guangdong Provincial People's Hospital
Investigators
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: Jiyan Chen, Director, Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT04407936    
Other Study ID Numbers: GDREC2019555H
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Keywords provided by Jiyan Chen, Guangdong Provincial People's Hospital:
contrast-induced acute kidney injury
contrast medium
creatinine clearance
coronary angiography
chronic kidney disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases