Coronary Artery DiseaseCRUISENCT04953819
Coronary Revascularization in Patients With Dialysis in China
An observational study of Coronary Artery Disease and Dialysis, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
China patients in end stage renal disease receiving maintenance dialysis have a high risk of cardiovascular disease (CVD), with a prevalence of 45.5% approximately, and coronary artery disease (CAD) has been identified as the most common one. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease, Dialysis, Intervention
- What is being tested?
- Revascularization and Medical therapy
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 31 Aug 2023
- How long will I take part?
- 12 Months
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of this study will be selected from around 30 different hospitals in 7 different areas in China.
Who may be able to join
- Aged 18 or above and 85 or below.
- Receives peritoneal dialysis or hemodialysis more than 1-time weekly and for more than 3 months.
- Diagnosed with coronary artery disease, including STEMI, NST-ACD, stable coronary artery disease.
Who cannot join
- Pregnancy or lactation.
- Can't be cooperative because of a mental illness or other reasons.
- Malignant tumor or severe hepatic disease.
- Life expectancy is less than 1 year.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100000
Zhengqin Zhai, MD, 18612511571, zhengqin712@outlook.com
About this study
Official title: Coronary RevascUlarization in Patients With End-stage Renal dIsease on dialysiS in China: a Nationwide and multicEnter Cohort Study.
China patients in end stage renal disease receiving maintenance dialysis have a high risk of cardiovascular disease (CVD), with a prevalence of 45.5% approximately, and coronary artery disease (CAD) has been identified as the most common one. It remains unclear that what their treatment status is and whether this group of patients can benefit from revascularization in China. The investigators plan to recruit around 30 hospitals from 7 regions as study centers, which represent different levels of economic development in Mainland China. The detailed information includes demographics, medical history, coronary angiogram, in-hospital treatment and procedures, short-term and long-term outcomes. The aim of the study is to provide the real world knowledge about current status of coronary revascularization and prognosis in patients with CAD and dialysis.
- Conditions
- Coronary Artery Disease, Dialysis, Intervention
- Being tested
- Revascularization, Medical therapy
- Keywords
- dialysis, coronary artery disease, revascularization, optimal medical therapy, prognosis
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevascularizationOther
Also called Catheterization or coronary bypass grafting
Percutaneous coronary intervention and/or coronary bypass grafting for coronary artery disease
Medical therapyOther
Optimal medical therapy for coronary artery disease
| Study group | Role | What they receive |
|---|---|---|
| Revascularization group | This group includes patients with dialysis who have received revascularization by percutaneous coronary intervention or coronary artery bypass grafting for coronary artery disease. Receives: Other: Revascularization | |
| Medical treatment group | This group includes patients who have received medical therapy for coronary artery disease, not percutaneous coronary intervention or coronary artery bypass grafting. Receives: Other: Medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all-cause death
All-cause deaths includes cardiac death, vascular death and non-cardiovascular death.
- Cardiac death: any death due to proximate cardiac cause (eg, MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death.
- Vascular death: caused by noncoronary vascular causes, such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular diseases.
- 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: the duration of hospital stay, an expected average of 2 weeks
Incidence of all-cause death and non-fatal myocardial infarction
Non-fatal myocardial infarction is defined as elevated cardiac enzymes (troponin or myocardial band fraction of creatine kinase) above the upper reference limit with ischemic symptoms or electrocardiography findings indicative of ischemia that is not related to the index procedure.
Measured: 12-month follow-up
Secondary outcomes (3)
Incidence of all-cause death and non-fatal myocardial infarction
Definitions of all-cause death and non-fatal myocardial infarction as mentioned above.
Measured: within 30 days after discharge
Incidence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, repeat revascularization, cardiovascular rehospitalization.
- Definitions of all-cause death and non-fatal myocardial infarction as mentioned above.
- Non-fatal stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause.
- Repeat revascularization is any unplanned repeat revascularization of either a target vessel or non-target vessel or CABG.
- Cardiovascular rehospitalization is rehospitalization due to MI, angina, heart failure, stroke, arrhythmia or conduction disturbance, sudden cardiac arrest and other cardiovascular problem.
Measured: 12-month follow-up
Incidence of bleeding
Bleeding Academic Research Consortium (BARC) type 2 to 5 bleeding.
Measured: 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Nov 2020
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingang Zheng, China-Japan Friendship Hospital
- Investigators
- Jingang Zheng, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953819
- Sponsor's protocol ID
- 2020-112-K71
- Acronym
- CRUISE
- Status last verified
- Jun 2021
- First submitted
- 16 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. 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: a Nationwide and multicEnter Cohort Study.
- ClinicalTrials.gov ID
- NCT04953819
- Acronym / sponsor ID
- CRUISE / 2020-112-K71
- Conditions
- Coronary Artery Disease, Dialysis, Intervention
- Keywords
- dialysis, coronary artery disease, revascularization, optimal medical therapy, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 8 Jul 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.
China patients in end stage renal disease receiving maintenance dialysis have a high risk of cardiovascular disease (CVD), with a prevalence of 45.5% approximately, and coronary artery disease (CAD) has been identified as the most common one. It remains unclear that what their treatment status is and whether this group of patients can benefit from revascularization in China. The investigators plan to recruit around 30 hospitals from 7 regions as study centers, which represent different levels of economic development in Mainland China. The detailed information includes demographics, medical history, coronary angiogram, in-hospital treatment and procedures, short-term and long-term outcomes. The aim of the study is to provide the real world knowledge about current status of coronary revascularization and prognosis in patients with CAD and dialysis.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Revascularization group | – | Other: RevascularizationThis group includes patients with dialysis who have received revascularization by percutaneous coronary intervention or coronary artery bypass grafting for coronary artery disease. |
| Medical treatment group | – | Other: Medical therapyThis group includes patients who have received medical therapy for coronary artery disease, not percutaneous coronary intervention or coronary artery bypass grafting. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of this study will be selected from around 30 different hospitals in 7 different areas in China.
Key inclusion criteria (3 listed)
- Aged 18 or above and 85 or below.
- Receives peritoneal dialysis or hemodialysis more than 1-time weekly and for more than 3 months.
- Diagnosed with coronary artery disease, including STEMI, NST-ACD, stable coronary artery disease.
Key exclusion criteria (4 listed)
- Pregnancy or lactation.
- Can't be cooperative because of a mental illness or other reasons.
- Malignant tumor or severe hepatic disease.
- Life expectancy is less than 1 year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RevascularizationAlso: Catheterization or coronary bypass graftingPercutaneous coronary intervention and/or coronary bypass grafting for coronary artery disease | Other | Revascularization group |
| Medical therapyOptimal medical therapy for coronary artery disease | Other | Medical treatment group |
Primary outcome
Incidence of all-cause death
Time frame: the duration of hospital stay, an expected average of 2 weeks
All-cause deaths includes cardiac death, vascular death and non-cardiovascular death. 1. Cardiac death: any death due to proximate cardiac cause (eg, MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death. 2. Vascular death: caused by noncoronary vascular causes, such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular diseases. 3. 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.
Incidence of all-cause death and non-fatal myocardial infarction
Time frame: 12-month follow-up
Non-fatal myocardial infarction is defined as elevated cardiac enzymes (troponin or myocardial band fraction of creatine kinase) above the upper reference limit with ischemic symptoms or electrocardiography findings indicative of ischemia that is not related to the index procedure.
3 secondary outcomes
Incidence of all-cause death and non-fatal myocardial infarction
Time frame: within 30 days after discharge
Incidence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, repeat revascularization, cardiovascular rehospitalization.
Time frame: 12-month follow-up
Incidence of bleeding
Time frame: 12-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- 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 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 Dialysis, 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 3 inclusion and 4 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 8 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhengqin Zhai (+86 18612511571, zhengqin712@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of all-cause death (time frame: the duration of hospital stay, an expected average of 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2021.