Coronary Artery DiseaseCRUISE-RNCT05841082
Coronary Revascularization in Patients On Dialysis in China-Retrospective Registry
An observational study of Coronary Artery Disease and End Stage Renal Disease, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
Coronary artery disease (CAD) is the leading cause of death in end-stage renal disease (ESRD) patients requiring dialysis. There are limited data on clinical characteristics, treatment strategies and outcomes in this special patient population in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, End Stage Renal Disease, Dialysis
- How many people
- 1,249 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 30 Jun 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of this study will be selected from January 2015 to June 2021 among 30 tertiary medical centers across 12 provinces in China
Who may be able to join
- 50% or greater stenosis in any of three main coronary arteries or left main coronary artery on visual assessment of the coronary angiogram
- Receive peritoneal dialysis or hemodialysis for more than 3 months
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: Coronary RevascUlarIzation in Patients With End-StagE Renal Disease on Dialysis in China-Retrospective Registry
Coronary artery disease (CAD) is the leading cause of death in end-stage renal disease (ESRD) patients requiring dialysis. There are limited data on clinical characteristics, treatment strategies and outcomes in this special patient population in China. As a nationwide, observational, multicenter cohort study, this study consecutively included ESRD patients on dialysis with significant CAD at 30 tertiary care centers in 12 provinces in China from January 2015 to June 2021. Patient data collected included demographics, comorbidities, cardiac history, cardiac function, location and severity of CAD, procedural information, medications, and clinical events.
- Conditions
- Coronary Artery Disease, End Stage Renal Disease, Dialysis
- Keywords
- coronary artery disease, end-stage renal disease, cardiac catheterizations, percutaneous coronary intervention, coronary artery bypass grafting, prognosis, metabolic Syndrome, revascularization, optimal medical therapy
- Medical subject headings
- Coronary Artery Disease, Kidney Failure, Chronic, Metabolic Syndrome
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 |
|---|---|---|
| CAD | The investigators recruited all consecutive end-stage renal disease patients requiring dialysis who had significant coronary artery disease, defined as 50% or greater stenosis in any of three main coronary arteries or left main coronary artery on visual assessment of the coronary angiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death
All-cause deaths include cardiovascular death and non-cardiovascular death. Cardiovascular death is defined as death due to acute myocardial infarction, heart failure, sudden cardiac death, stroke, cardiovascular procedure, or cardiovascular hemorrhage. Non-cardiovascular death: any death not covered by the above definitions, such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide, or trauma.
Measured: 12-month follow-up
Secondary outcomes (8)
Major adverse cardiovascular events
A composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.
Measured: From the hospital admission to 12-month follow-up
Major or clinically relevant nonmajor bleeding
A bleeding event meeting Bleeding Academic Research Consortium criteria type 2, 3, or 5.
Measured: From the hospital admission to 12-month follow-up
Cardiovascular death
Cardiovascular death is defined as death due to acute myocardial infarction, heart failure, sudden cardiac death, stroke, cardiovascular procedure, or cardiovascular hemorrhage.
Measured: From the hospital admission to 12-month follow-up
Non-fatal myocardial infarction
Non-fatal myocardial infarction is confirmed in patients with ischemic symptoms, elevated serum cardiac biomarkers and/or distinctive ECG changes.
Measured: From the hospital admission to 12-month follow-up
Non-fatal myocardial stroke
Non-fatal myocardial stroke is confirmed as a new neurological deficit attributed to a vascular cause in the central nervous system with imaging evidence by computed tomography or magnetic resonance imaging.
Measured: From the hospital admission to 12-month follow-up
Major bleeding
A bleeding event meeting Bleeding Academic Research Consortium criteria type 3, or 5.
Measured: From the hospital admission to 12-month follow-up
Clinically relevant nonmajor bleeding
A bleeding event meeting Bleeding Academic Research Consortium criteria type 2.
Measured: From the hospital admission to 12-month follow-up
Follow-up major adverse cardiovascular and clinical events
We will follow up the patients by telephone and outpatient service to know the all-cause mortality (cardiovascular and non-cardiovascular) and cardiovascular events.
Measured: From the hospital admission, and up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Jan 2015
- Primary completion30 Jun 2021
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship 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
- 1,249 participants (actual)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aerospace Center Hospital, Beijing Chao Yang Hospital, Cangzhou Central Hospital of Tianjin Medical University, Civil Aviation General Hospital, Dongguan Tungwah Hospital, Emergency General Hospital, Fifth Affiliated Hospital of Xinjiang Medical University, First Central Hospital of Tianjin, Fuwai Yunnan Cardiovascular Hospital, Guangdong Provincial People's Hospital, Henan Provincial Chest Hospital, Ningbo No. 1 Hospital, Peking University People's Hospital, Peking University Shougang Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, Tianjin Medical University Second Hospital, Shaoxing People's Hospital, Shengjing Hospital, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital of Harbin Medical University, Zhejiang University, People's Hospital of Guangxi Zhuang Autonomous Region, The Third People's Hospital of Chengdu, Tianjin Medical University General Hospital, Tianjin Union Medicine Center, Tongji Hospital, West China Hospital, Xuanwu Hospital, Beijing, Wuhan University
- Responsible party
- Principal investigator, Jingang Zheng, China-Japan Friendship Hospital
- Investigators
- Jingang Zheng, MD, PhD, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841082
- Sponsor's protocol ID
- CRUISE-2020-12-28
- Acronym
- CRUISE-R
- Status last verified
- May 2023
- First submitted
- 22 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhao X, Xie E, Zhai Z, Sun D, Shen S, He H, Liu W, Cai L, Zeng H, Zheng J. A New and Robust Prognostic Biomarker for Mortality Risk Prediction in Dialysis Patients With Coronary Artery Disease: Red Cell Distribution Width-to-Albumin Ratio. Rev Cardiovasc Med. 2026 Apr 20;27(4):47939. doi: 10.31083/RCM47939. eCollection 2026 Apr.
PubMed 42110186Li Y, Xie E, Chen Q, Gao Y, Meng Z, Yu C, Yang Y, Sheng Z, Fu C, Du L, Pang W, Chen M, Zheng J. Effects of Angiotensin-Converting Enzyme Inhibitors/Angiotensin II Receptor Blockers on Prognosis in Acute Coronary Syndrome Patients with Preserved Ejection Fraction Undergoing Regular Dialysis. Cardiovasc Drugs Ther. 2026 Apr;40(2):589-598. doi: 10.1007/s10557-025-07720-2. Epub 2025 Jun 10.
PubMed 40493132Xie E, Wu Y, Ye Z, He Y, Zeng H, Luo J, Chen M, Pang W, Xu Y, Gao C, Guo X, Cai L, Ji Q, Yang Y, Wu D, Yuan Y, Wan J, Ma Y, Zhang J, Du Z, Yang Q, Cheng J, Ding C, Ma X, Yin C, Fan Z, Tang Q, Li Y, Sun L, Lu C, Chi J, Yao Z, Gao Y, Yu C, Ren J, Zheng J. Percutaneous coronary intervention vs . medical therapy in patients on dialysis with coronary artery disease in China. Chin Med J (Engl). 2025 Feb 5;138(3):301-310. doi: 10.1097/CM9.0000000000003295. Epub 2024 Sep 25.
PubMed 39317971
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary RevascUlarIzation in Patients With End-StagE Renal Disease on Dialysis in China-Retrospective Registry
- ClinicalTrials.gov ID
- NCT05841082
- Acronym / sponsor ID
- CRUISE-R / CRUISE-2020-12-28
- Conditions
- Coronary Artery Disease, End Stage Renal Disease, Dialysis
- Keywords
- coronary artery disease, end-stage renal disease, cardiac catheterizations, percutaneous coronary intervention, coronary artery bypass grafting, prognosis, metabolic Syndrome, revascularization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,249 participants (actual)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- Aerospace Center Hospital, Beijing Chao Yang Hospital, Cangzhou Central Hospital of Tianjin Medical University, Civil Aviation General Hospital, Dongguan Tungwah Hospital, Emergency General Hospital, Fifth Affiliated Hospital of Xinjiang Medical University, First Central Hospital of Tianjin, Fuwai Yunnan Cardiovascular Hospital, Guangdong Provincial People's Hospital, Henan Provincial Chest Hospital, Ningbo No. 1 Hospital, Peking University People's Hospital, Peking University Shougang Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, Tianjin Medical University Second Hospital, Shaoxing People's Hospital, Shengjing Hospital, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital of Harbin Medical University, Zhejiang University, People's Hospital of Guangxi Zhuang Autonomous Region, The Third People's Hospital of Chengdu, Tianjin Medical University General Hospital, Tianjin Union Medicine Center, Tongji Hospital, West China Hospital, Xuanwu Hospital, Beijing, Wuhan University
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 3 May 2023 (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.
Coronary artery disease (CAD) is the leading cause of death in end-stage renal disease (ESRD) patients requiring dialysis. There are limited data on clinical characteristics, treatment strategies and outcomes in this special patient population in China. As a nationwide, observational, multicenter cohort study, this study consecutively included ESRD patients on dialysis with significant CAD at 30 tertiary care centers in 12 provinces in China from January 2015 to June 2021. Patient data collected included demographics, comorbidities, cardiac history, cardiac function, location and severity of CAD, procedural information, medications, and clinical events.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAD | – | –The investigators recruited all consecutive end-stage renal disease patients requiring dialysis who had significant coronary artery disease, defined as 50% or greater stenosis in any of three main coronary arteries or left main coronary artery on visual assessment of the coronary angiogram |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of this study will be selected from January 2015 to June 2021 among 30 tertiary medical centers across 12 provinces in China
Key inclusion criteria (2 listed)
- 50% or greater stenosis in any of three main coronary arteries or left main coronary artery on visual assessment of the coronary angiogram
- Receive peritoneal dialysis or hemodialysis for more than 3 months
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
All-cause death
Time frame: 12-month follow-up
All-cause deaths include cardiovascular death and non-cardiovascular death. Cardiovascular death is defined as death due to acute myocardial infarction, heart failure, sudden cardiac death, stroke, cardiovascular procedure, or cardiovascular hemorrhage. Non-cardiovascular death: any death not covered by the above definitions, such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide, or trauma.
8 secondary outcomes
Major adverse cardiovascular events
Time frame: From the hospital admission to 12-month follow-up
Major or clinically relevant nonmajor bleeding
Time frame: From the hospital admission to 12-month follow-up
Cardiovascular death
Time frame: From the hospital admission to 12-month follow-up
Non-fatal myocardial infarction
Time frame: From the hospital admission to 12-month follow-up
Non-fatal myocardial stroke
Time frame: From the hospital admission to 12-month follow-up
Major bleeding
Time frame: From the hospital admission to 12-month follow-up
Clinically relevant nonmajor bleeding
Time frame: From the hospital admission to 12-month follow-up
Follow-up major adverse cardiovascular and clinical events
Time frame: From the hospital admission, and up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 42110186Zhao X, Xie E, Zhai Z, Sun D, Shen S, He H, Liu W, Cai L, Zeng H, Zheng J. A New and Robust Prognostic Biomarker for Mortality Risk Prediction in Dialysis Patients With Coronary Artery Disease: Red Cell Distribution Width-to-Albumin Ratio. Rev Cardiovasc Med. 2026 Apr 20;27(4):47939. doi: 10.31083/RCM47939. eCollection 2026 Apr.
- Derived from this study: PubMed 40493132Li Y, Xie E, Chen Q, Gao Y, Meng Z, Yu C, Yang Y, Sheng Z, Fu C, Du L, Pang W, Chen M, Zheng J. Effects of Angiotensin-Converting Enzyme Inhibitors/Angiotensin II Receptor Blockers on Prognosis in Acute Coronary Syndrome Patients with Preserved Ejection Fraction Undergoing Regular Dialysis. Cardiovasc Drugs Ther. 2026 Apr;40(2):589-598. doi: 10.1007/s10557-025-07720-2. Epub 2025 Jun 10.
- Derived from this study: PubMed 39317971Xie E, Wu Y, Ye Z, He Y, Zeng H, Luo J, Chen M, Pang W, Xu Y, Gao C, Guo X, Cai L, Ji Q, Yang Y, Wu D, Yuan Y, Wan J, Ma Y, Zhang J, Du Z, Yang Q, Cheng J, Ding C, Ma X, Yin C, Fan Z, Tang Q, Li Y, Sun L, Lu C, Chi J, Yao Z, Gao Y, Yu C, Ren J, Zheng J. Percutaneous coronary intervention vs . medical therapy in patients on dialysis with coronary artery disease in China. Chin Med J (Engl). 2025 Feb 5;138(3):301-310. doi: 10.1097/CM9.0000000000003295. Epub 2024 Sep 25.
- 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.
Jingang Zheng, MD, PhD principal investigator
China-Japan Friendship 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 Coronary Artery Disease and End Stage Renal Disease, run by China-Japan Friendship 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 2 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: status not confirmed, as of the sponsor's last update on 6 May 2023. 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?
Results are not available in the source record.
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 death (time frame: 12-month 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 NCT05841082, which also lists 3 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 6 May 2023.