Cardio-Renal SyndromeNCT05050877
Risk Factors and Prognosis of Adverse Cardiovascular and Kidney Events After Coronary Intervention II
An observational study of Cardio-Renal Syndrome and Coronary Angiography, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardio-Renal Syndrome, Coronary Angiography, Coronary Artery Disease
- How many people
- 184,855 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2000to 31 Dec 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.
About this study
Official title: Risk Factors and Prognosis of Adverse Cardiovascular and Kidney Events After Coronary Intervention - Cardiorenal ImprovemeNt Registry 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.
Read the 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.
- 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
- 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 group | Role | What they receive |
|---|---|---|
| coronary angiography | The 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.
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
Secondary outcomes (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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start1 Jun 2000
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Cardio-Renal SyndromeStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 184,855 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Fujian Medical University, Maoming Hospital Affiliated to Southern Medical University, Shenzhen People's Hospital, Yangjiang People's Hospital
- Responsible party
- Principal investigator, Jiyan Chen, Guangdong Provincial People's Hospital
- Investigators
- Yong Liu, MD,PhD, Study director, Guangdong Cardiovascular Institute,Guangdong Provincial People's HospitalShiqun Chen, MS, Study director, Guangdong Cardiovascular Institute,Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050877
- Sponsor's protocol ID
- 2019-555H-2
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2021
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Chen J, Lu X, Ruan X, Li Z, Aji Y, Mohsen AAFA, Guo W, Chen J, Chen S, Xu J, Liu J, Liu Y. Lipoprotein(a) and Prognostic Nutritional Index Levels Exhibit Interactive and Joint Effects on Mortality Risk in Patients With Coronary Artery Disease: Findings From a Real-World Study. Rev Cardiovasc Med. 2026 Oct 16;27(10):51948. doi: 10.31083/RCM51948. eCollection 2026 Oct.
PubMed 42985587Pan W, Lu X, Zhou Z, Liu J, Zhang S, Huang H, He Y, Deng J, Ling Y, Ruan X, Jing L, Zhang W, Chen S, Liao X, Chen J, Zhuang X, Liu Y. Excess apolipoprotein B predicts long-term survival in statin-treated CAD irrespective of achieved LDL-C levels: a pooled cohort analysis. Lipids Health Dis. 2026 Mar 24;25(1):124. doi: 10.1186/s12944-026-02928-z.
PubMed 41877106Liu J, Ruan H, Lu X, Ye W, Huang H, Tang S, Yuan Z, Huang Z, Chen S, Tan N, Chen J, Liu Y. Systemic inflammation affects the association between pericoronary fat attenuation index and adverse cardiovascular risk in patients with coronary artery disease. Int J Cardiovasc Imaging. 2026 Jul;42(7):1289-1300. doi: 10.1007/s10554-026-03662-4. Epub 2026 Feb 23.
PubMed 41729387Lu X, Wei P, Tang S, Ye W, Huang Z, Yuan Z, Ruan H, Huang H, Zhang W, Wang C, Kang Y, Hu J, Li Z, Deng J, Li Y, Wu W, Ming WK, Wong CK, Tan N, Chen S, Liu J, Chen J, Liu Y. Pericoronary fat attenuation index on coronary CT angiography and cardiovascular risk in patients with coronary artery disease and chronic kidney disease. BMC Nephrol. 2025 Nov 12;26(1):632. doi: 10.1186/s12882-025-04549-7.
PubMed 41225370Deng L, Chen H, Xu Q, Han K, Liu J, Chen S, Deng J, Tian L, Li Z, Lu X, Liu Y, Liang Y. The High-Sensitivity C-Reactive Protein to High-Density Lipoprotein Cholesterol Ratio and the Risk of Contrast-Induced Acute Kidney Injury in Patients Undergoing Percutaneous Coronary Intervention. Rev Cardiovasc Med. 2024 Sep 23;25(9):338. doi: 10.31083/j.rcm2509338. eCollection 2024 Sep.
PubMed 39355575Zhou Z, Qiao L, Ling Y, He Y, Chang T, Lu H, Yu S, Liu J, Guo W, Chen S, Liu Y, Chen J. Intermediate Hyperglycemia Increases the Risk of All-Cause Mortality in Premature Coronary Artery Disease Patients Undergoing Percutaneous Coronary Intervention. Rev Cardiovasc Med. 2023 Dec 13;24(12):352. doi: 10.31083/j.rcm2412352. eCollection 2023 Dec.
PubMed 39077077Xie Y, Xu X, Wang D, Zhou Y, Kang Y, Lai W, Lu H, Liu J, Chen S, Xu J, Yan X, Huang X, Liu Y. Fibrinogen-to-Albumin Ratio and Long-Term Mortality in Coronary Artery Disease Patients with Different Glucose Metabolism Status. Rev Cardiovasc Med. 2023 Nov 16;24(11):317. doi: 10.31083/j.rcm2411317. eCollection 2023 Nov.
PubMed 39076427Wu W, Jia C, Xu X, He Y, Xie Y, Zhou Y, Lu H, Liu J, Chen J, Liu Y. Impact of Platelet-to-HDL-Cholesterol Ratio on Long-Term Mortality in Coronary Artery Disease Patients with or Without Type 2 Diabetes: Insights from a Chinese Multicenter Cohort. J Inflamm Res. 2024 May 6;17:2731-2744. doi: 10.2147/JIR.S458950. eCollection 2024.
PubMed 38737110Jia C, Wu W, Lu H, Liu J, Chen S, Liang G, Zhou Y, Yu S, Qiao L, Chen J, Tan N, Liu Y, Chen J. Fibrinogen to HDL-Cholesterol ratio as a predictor of mortality risk in patients with acute myocardial infarction. Lipids Health Dis. 2024 Mar 25;23(1):86. doi: 10.1186/s12944-024-02071-7.
PubMed 38528580Lu J, He Y, Yang Y, Zhong X, Chen S, Wu B, Pan Y, Wang Y, Xiu J, Kang Y, Liu J, Liu Y, Chen S, Chen K, Chen L. Age-Related Effect of Uric Acid on Contrast-Induced Acute Kidney Injury of Patients Undergoing Coronary Angiography. Clin Interv Aging. 2023 Dec 7;18:2053-2061. doi: 10.2147/CIA.S419370. eCollection 2023.
PubMed 38088947Liu J, Chen S, Zhou Y, Huang H, Li Q, Liang Y, Dong S, Huang X, Chen L, Zheng X, Meng R, Jia C, Chen J, Tan N, Liu Y. Proportion and number of incident cancer deaths in coronary artery disease. Cancer Med. 2023 Oct;12(19):20140-20149. doi: 10.1002/cam4.6595. Epub 2023 Sep 27.
PubMed 37754571Liu J, Chen S, Zhou Y, Zheng X, Meng R, Tan N, Liu Y. Effect of cumulative radiation exposure from Coronary catheterization on lung cancer mortality. BMC Cancer. 2023 Aug 15;23(1):757. doi: 10.1186/s12885-023-11231-4.
PubMed 37582730Gao F, Huang Z, Liang J, Kang Y, Ling Y, He Y, Chen J, Hong D, Zhang Z, Xu S, Wang A, Yan X, Liu J, Liu Y, Chen S, Chen J. Association of malnutrition with all-cause and cardiovascular mortality in patients with mild to severe chronic kidney disease undergoing coronary angiography: a large multicenter longitudinal study. Int Urol Nephrol. 2023 Dec;55(12):3225-3236. doi: 10.1007/s11255-023-03566-5. Epub 2023 Apr 27.
PubMed 37103656
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Prognosis of Adverse Cardiovascular and Kidney Events After Coronary Intervention - Cardiorenal ImprovemeNt Registry II
- ClinicalTrials.gov ID
- NCT05050877
- Acronym / sponsor ID
- 2019-555H-2
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184,855 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Fujian Medical University, Maoming Hospital Affiliated to Southern Medical University, Shenzhen People's Hospital, Yangjiang People's Hospital
- Study start
- 1 Jun 2000 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coronary angiography | – | –The investigators recruit all consecutive patients who were undergoing coronary angiography or percutaneous coronary intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigators reviewed all consecutive patients who were undergoing coronary angiography.
Key inclusion criteria (1 listed)
- 1. Patients referred to CAG or PCI;
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcomes
Cystatin C based CI-AKI (CI-AKI cyc)
Time frame: 24-48 hours
The change of eGFR, calculate based on CrCl and serum cystatin C
Time frame: 48-72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Derived from this study: PubMed 42985587Chen J, Lu X, Ruan X, Li Z, Aji Y, Mohsen AAFA, Guo W, Chen J, Chen S, Xu J, Liu J, Liu Y. Lipoprotein(a) and Prognostic Nutritional Index Levels Exhibit Interactive and Joint Effects on Mortality Risk in Patients With Coronary Artery Disease: Findings From a Real-World Study. Rev Cardiovasc Med. 2026 Oct 16;27(10):51948. doi: 10.31083/RCM51948. eCollection 2026 Oct.
- Derived from this study: PubMed 41877106Pan W, Lu X, Zhou Z, Liu J, Zhang S, Huang H, He Y, Deng J, Ling Y, Ruan X, Jing L, Zhang W, Chen S, Liao X, Chen J, Zhuang X, Liu Y. Excess apolipoprotein B predicts long-term survival in statin-treated CAD irrespective of achieved LDL-C levels: a pooled cohort analysis. Lipids Health Dis. 2026 Mar 24;25(1):124. doi: 10.1186/s12944-026-02928-z.
- Derived from this study: PubMed 41729387Liu J, Ruan H, Lu X, Ye W, Huang H, Tang S, Yuan Z, Huang Z, Chen S, Tan N, Chen J, Liu Y. Systemic inflammation affects the association between pericoronary fat attenuation index and adverse cardiovascular risk in patients with coronary artery disease. Int J Cardiovasc Imaging. 2026 Jul;42(7):1289-1300. doi: 10.1007/s10554-026-03662-4. Epub 2026 Feb 23.
- Derived from this study: PubMed 41225370Lu X, Wei P, Tang S, Ye W, Huang Z, Yuan Z, Ruan H, Huang H, Zhang W, Wang C, Kang Y, Hu J, Li Z, Deng J, Li Y, Wu W, Ming WK, Wong CK, Tan N, Chen S, Liu J, Chen J, Liu Y. Pericoronary fat attenuation index on coronary CT angiography and cardiovascular risk in patients with coronary artery disease and chronic kidney disease. BMC Nephrol. 2025 Nov 12;26(1):632. doi: 10.1186/s12882-025-04549-7.
- Derived from this study: PubMed 39355575Deng L, Chen H, Xu Q, Han K, Liu J, Chen S, Deng J, Tian L, Li Z, Lu X, Liu Y, Liang Y. The High-Sensitivity C-Reactive Protein to High-Density Lipoprotein Cholesterol Ratio and the Risk of Contrast-Induced Acute Kidney Injury in Patients Undergoing Percutaneous Coronary Intervention. Rev Cardiovasc Med. 2024 Sep 23;25(9):338. doi: 10.31083/j.rcm2509338. eCollection 2024 Sep.
- Derived from this study: PubMed 39077077Zhou Z, Qiao L, Ling Y, He Y, Chang T, Lu H, Yu S, Liu J, Guo W, Chen S, Liu Y, Chen J. Intermediate Hyperglycemia Increases the Risk of All-Cause Mortality in Premature Coronary Artery Disease Patients Undergoing Percutaneous Coronary Intervention. Rev Cardiovasc Med. 2023 Dec 13;24(12):352. doi: 10.31083/j.rcm2412352. eCollection 2023 Dec.
- Derived from this study: PubMed 39076427Xie Y, Xu X, Wang D, Zhou Y, Kang Y, Lai W, Lu H, Liu J, Chen S, Xu J, Yan X, Huang X, Liu Y. Fibrinogen-to-Albumin Ratio and Long-Term Mortality in Coronary Artery Disease Patients with Different Glucose Metabolism Status. Rev Cardiovasc Med. 2023 Nov 16;24(11):317. doi: 10.31083/j.rcm2411317. eCollection 2023 Nov.
- Derived from this study: PubMed 38737110Wu W, Jia C, Xu X, He Y, Xie Y, Zhou Y, Lu H, Liu J, Chen J, Liu Y. Impact of Platelet-to-HDL-Cholesterol Ratio on Long-Term Mortality in Coronary Artery Disease Patients with or Without Type 2 Diabetes: Insights from a Chinese Multicenter Cohort. J Inflamm Res. 2024 May 6;17:2731-2744. doi: 10.2147/JIR.S458950. eCollection 2024.
- Derived from this study: PubMed 38528580Jia C, Wu W, Lu H, Liu J, Chen S, Liang G, Zhou Y, Yu S, Qiao L, Chen J, Tan N, Liu Y, Chen J. Fibrinogen to HDL-Cholesterol ratio as a predictor of mortality risk in patients with acute myocardial infarction. Lipids Health Dis. 2024 Mar 25;23(1):86. doi: 10.1186/s12944-024-02071-7.
- Derived from this study: PubMed 38088947Lu J, He Y, Yang Y, Zhong X, Chen S, Wu B, Pan Y, Wang Y, Xiu J, Kang Y, Liu J, Liu Y, Chen S, Chen K, Chen L. Age-Related Effect of Uric Acid on Contrast-Induced Acute Kidney Injury of Patients Undergoing Coronary Angiography. Clin Interv Aging. 2023 Dec 7;18:2053-2061. doi: 10.2147/CIA.S419370. eCollection 2023.
- Derived from this study: PubMed 37754571Liu J, Chen S, Zhou Y, Huang H, Li Q, Liang Y, Dong S, Huang X, Chen L, Zheng X, Meng R, Jia C, Chen J, Tan N, Liu Y. Proportion and number of incident cancer deaths in coronary artery disease. Cancer Med. 2023 Oct;12(19):20140-20149. doi: 10.1002/cam4.6595. Epub 2023 Sep 27.
- Derived from this study: PubMed 37582730Liu J, Chen S, Zhou Y, Zheng X, Meng R, Tan N, Liu Y. Effect of cumulative radiation exposure from Coronary catheterization on lung cancer mortality. BMC Cancer. 2023 Aug 15;23(1):757. doi: 10.1186/s12885-023-11231-4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Liu, MD,PhD study director
Guangdong Cardiovascular Institute,Guangdong Provincial People's Hospital
Shiqun Chen, MS study director
Guangdong Cardiovascular Institute,Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
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 21 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?
Contrast-Induced Acute Kidney Injury (CI-AKI 0.3) (time frame: 48 hours). 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 NCT05050877, which also lists 13 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 21 Sep 2021.