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Cardio-Renal SyndromeNCT04407936

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

An observational study of Cardio-Renal Syndrome and Coronary Angiography, run by Guangdong Provincial People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 January 2007 to Decemeber 2018. Read more about this study

Who is it for?
Any age
How many people
88,938 participants
Where
1 siteChina
Study dates
1 Jun 2007to 10 Mar 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The investigators reviewed all consecutive patients who were undergoing coronary angiography

Who may be able to join

  • 1. Patients referred to CAG or PCI;

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

China1 site

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

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 January 2007 to Decemeber 2018. The hospitalization information was collected in the form of direct derivation of the case, and cardiac and renal adverse events were collected through outpatient recorder system. All-cause death information was obtained from the Public Security and matched to the electronic Clinical Management System of the Guangdong Provincial People's Hospital records.

Read the detailed description

This is a single center, retrospective observation study collecting data on 88938 coronary angiography and / or coronary intervention patients from January 2007 to Decemeber 2018. 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 All-cause mortality, and secondary endpoints are Adverse Cardiovascular and Kidney Events.

Keywords
contrast-induced acute kidney injury, contrast medium, creatinine clearance, coronary angiography, chronic kidney disease, Adverse Cardiovascular and Kidney Events
Medical subject headings
Cardio-Renal Syndrome, Coronary Artery Disease, Kidney Diseases, Metabolic Syndrome, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04407936
Study groupRoleWhat they receive
coronary angiographyThe investigators recruit all consecutive patients who were undergoing coronary angiography or percutaneous coronary intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality

    Admission Patients Died for all-cause mortality within 13 years.

    Measured: From hospital admission to 13 years follow-up

Secondary outcomes (6)

  1. 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

    Measured: 48 hours

  2. 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

    Measured: 24-48 hours

  3. 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.

    Measured: 48-72 hours

  4. 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

    Measured: 3 months

  5. Incidence of major adverse cardiovascular events

    all-cause mortality (cardiovascular and noncardiovascular) and cardiovascular events.

    Measured: 3-12months

  6. 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.

    Measured: 3-12months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2020
  2. Study start1 Jun 2007
  3. Primary completion31 Dec 2018
  4. Study completion10 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
88,938 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04407936
Sponsor's protocol ID
GDREC2019555H
Status last verified
Sep 2021
First submitted
14 Apr 2020
Last updated
14 Sep 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Chen S, Huang Z, Liang Y, Zhao X, Aobuliksimu X, Wang B, He Y, Kang Y, Huang H, Li Q, Yao Y, Lu X, Qian X, Xie X, Liu J, Liu Y. Five-year mortality of heart failure with preserved, mildly reduced, and reduced ejection fraction in a 4880 Chinese cohort. ESC Heart Fail. 2022 Aug;9(4):2336-2347. doi: 10.1002/ehf2.13921. Epub 2022 Apr 18.

    PubMed 35437939

  • Lai W, Zhao X, Yu S, Mai Z, Zhou Y, Huang Z, Li Q, Huang H, Li H, Wei H, Guo D, Xie Y, Li S, Lu H, Liu J, Chen S, Liu Y. Chronic Kidney Disease Increases Risk of Incident HFrEF Following Percutaneous Coronary Intervention. Front Cardiovasc Med. 2022 Apr 1;9:856602. doi: 10.3389/fcvm.2022.856602. eCollection 2022.

    PubMed 35433884

  • Huang H, Liu J, Bao K, Huang X, Huang D, Wei H, Remutula N, Tuersun T, Lai W, Li Q, Wang B, He Y, Yang H, Chen S, Chen J, Chen K, Tan N, Wang X, Chen L, Liu Y. Prevalence and Mortality of Moderate or Severe Mitral Regurgitation Among Patients Undergoing Percutaneous Coronary Intervention With or Without Heart Failure: Results From CIN Study With 28,358 Patients. Front Cardiovasc Med. 2022 Mar 3;9:796447. doi: 10.3389/fcvm.2022.796447. eCollection 2022.

    PubMed 35310981

  • Chen L, Huang Z, Zhao X, Liang J, Lu X, He Y, Kang Y, Xie Y, Liu J, Liu Y, Yang J, Yu W, Deng W, Pan Y, Lu J, Yang Y, Xie X, Qian X, Xu Q, Chen L, Chen K, Chen S. Predictors and Mortality for Worsening Left Ventricular Ejection Fraction in Patients With HFpEF. Front Cardiovasc Med. 2022 Feb 24;9:820178. doi: 10.3389/fcvm.2022.820178. eCollection 2022.

    PubMed 35282383

  • Liu J, Huang Z, Huang H, He Y, Yu Y, Chen G, Liu L, Wang B, Li Q, Lai W, Xu D, Lu J, Yang Y, Chen L, Chen K, Tan N, Chen J, Chen S, Liu Y. Malnutrition in patients with coronary artery disease: Prevalence and mortality in a 46,485 Chinese cohort study. Nutr Metab Cardiovasc Dis. 2022 May;32(5):1186-1194. doi: 10.1016/j.numecd.2021.12.023. Epub 2022 Jan 6.

    PubMed 35260308

  • Chen S, Huang Z, Chen L, Zhao X, Kang Y, Lai W, Lu X, Zhou Y, He Y, Huang H, Li Q, Liu J, Liang Y, Dong S, Tan N, Liu Y, Chen J. Does Diabetes Mellitus Increase the Short- and Long-Term Mortality in Patients With Critical Acute Myocardial Infarction? Results From American MIMIC-III and Chinese CIN Cohorts. Front Endocrinol (Lausanne). 2021 Dec 14;12:797049. doi: 10.3389/fendo.2021.797049. eCollection 2021.

    PubMed 34970227

  • Huang Z, Yang Y, Lu J, Liang J, He Y, Yu Y, Huang H, Li Q, Wang B, Li S, Yan Z, Xu D, Liu Y, Chen K, Huang Z, Ni J, Liu J, Chen L, Chen S. Association of Lipoprotein(a)-Associated Mortality and the Estimated Glomerular Filtration Rate Level in Patients Undergoing Coronary Angiography: A 51,500 Cohort Study. Front Cardiovasc Med. 2021 Nov 17;8:747120. doi: 10.3389/fcvm.2021.747120. eCollection 2021.

    PubMed 34869651

  • Wang B, Guo Z, Liu J, Li H, Mai Z, Lin F, Ying M, Yu Y, Chen S, Li Q, Huang H, Wei W, Yang Y, Dong S, Zhou Y, Chen J, Tan N, Liu Y. Mild Malnutrition Contributes the Greatest to the Poor Prognosis in Coronary Artery Disease With Well-Controlled Low-Density Lipoprotein Cholesterol Levels: A 4,863 Chinese Cohort Study. Front Nutr. 2021 Sep 29;8:725537. doi: 10.3389/fnut.2021.725537. eCollection 2021.

    PubMed 34660661

  • Mai Z, Huang Z, Lai W, Li H, Wang B, Huang S, Shi Y, Yu S, Hu Q, Liu J, Zhang L, Liu Y, Chen J, Liang Y, Zhong S, Chen S. Association of Malnutrition, Left Ventricular Ejection Fraction Category, and Mortality in Patients Undergoing Coronary Angiography: A Cohort With 45,826 Patients. Front Nutr. 2021 Sep 16;8:740746. doi: 10.3389/fnut.2021.740746. eCollection 2021.

    PubMed 34604285

  • Liu J, Li Q, Lai D, Chen G, Wang B, Liu L, Huang H, Lun Z, Ying M, Chen G, Huang Z, Xu D, Meng L, Yan X, Qiu W, Tan N, Chen J, Liu Y, Chen S. Trends in incidence and long-term prognosis of acute kidney injury following coronary angiography in Chinese cohort with 11,943 patients from 2013 to 2017: an observational study. BMC Nephrol. 2021 Jun 25;22(1):235. doi: 10.1186/s12882-021-02427-6.

    PubMed 34172005

Questions about this trial

What is this clinical trial studying?

An observational study of Cardio-Renal Syndrome and Coronary Angiography, run by Guangdong Provincial People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality (time frame: From hospital admission to 13 years follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04407936, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.

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