Chronic Kidney DiseasesCRUISE-METNCT06383208
Cardiovascular-Renal Adverse Prognosis Assessment System for Coronary Heart Disease With Chronic Kidney Disease Based on Metabolomics
An observational study of Chronic Kidney Diseases and Coronary Heart Disease, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
Coronary heart disease (CHD) combined with chronic kidney disease (CKD) affects a substantial portion of the population and carries a significant disease burden, often leading to poor outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Coronary Heart Disease, Lipid Metabolism Disorders
- What is being tested?
- lipid metabolomics
- How many people
- 470 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 31 Mar 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population of this study will be selected from China-Japan Friendship Hospital
Who may be able to join
- Age 18-80 years old;
- Diagnosed with CHD during hospitalization through coronary angiography, including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation acute coronary syndrome (NST-ACS), stable angina pectoris;
- Patients with clarified renal function status.;
- CKD is defined as meeting one of the following criteria, with a duration of more than 3 months: eGFR < 60 ml/min/1.73 m² or eGFR ≥ 60 ml/min/1.73 m² and urinary albumin-to-creatinine ratio (uACR) ≥ 30 mg/g;
Who cannot join
- Pregnancy or lactation;
- Severe valve disease or severe mechanical complications requiring surgical intervention;
- Severe psychiatric illness or other reasons that impede follow-up compliance;
- Severe hematologic disorders or end-stage malignant tumors;
- Having undergone kidney transplantation or long-term maintenance dialysis;
- Severe liver disease (Child-Pugh class C);
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- Received acute renal failure dialysis treatment within 12 weeks prior to screening for enrollment;
- Severe chronic lung disease requiring long-term mechanical ventilation support or awaiting lung transplantation;
- Life expectancy less than 1 year.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality
Chen Qiang, MD, +86 13882712184, dawangchen@163.com
About this study
Official title: Cardiovascular-Renal Adverse oUtcome rIsk aSsessment systEm for Coronary Heart Disease Complicated With Chronic Kidney Disease Based on Targeted Lipid METabolomics
Coronary heart disease (CHD) combined with chronic kidney disease (CKD) affects a substantial portion of the population and carries a significant disease burden, often leading to poor outcomes. Despite efforts to strictly control traditional risk factors, the efficacy in improving outcomes for patients with both CHD and CKD has been limited. Recent advancements in lipid metabolism research have identified new lipid metabolites associated with the occurrence and prognosis of CHD and CKD. Our preliminary trial has shown that levels of certain lipid metabolites, such as Cer(18:1/16:0), HexCer(18:1/16:0), and PI(18:0/18:1), are notably elevated in patients with CHD and reduced kidney function compared to those with relatively normal kidney function. This suggests that dysregulation of these non-traditional lipid metabolites may contribute to residual risk for adverse outcomes in these patients.
Furthermore, the emerging concept of "cardiovascular-kidney-metabolic syndrome" and the availability of new treatment options highlight the urgent need for a risk stratification tool tailored to modern management strategies and treatment goals to guide preventive measures effectively. To address this, we propose to conduct a prospective cohort study focusing on CHD combined with CKD. This study aims to comprehensively understand the clinical characteristics, diagnosis, treatment status, and cardiovascular-kidney prognosis in these patients. Through advanced metabolomics analysis, we seek to identify lipid metabolism profiles and non-traditional lipid metabolites associated with the progression of coronary artery disease in CHD-CKD patients. Leveraging clinical databases and metabolomics data, we will develop a robust risk prediction model for adverse cardiovascular-kidney outcomes, providing valuable guidance for clinical diagnosis, treatment decisions, and ultimately improving patient prognosis.
- Being tested
- lipid metabolomics
- Keywords
- Chronic Kidney Diseases, Coronary Heart Disease, Lipid Metabolism Disorders, Cardiovascular-Renal adverse prognosis, Metabolomics
- Medical subject headings
- Renal Insufficiency, Chronic, Coronary Disease, Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lipid metabolomicsDiagnostic test
Extract 4 milliliters of fasting peripheral venous blood from enrolled patients for targeted lipid metabolism metabolomics research. Utilize a liquid chromatography-tandem mass spectrometry (LC-MS/MS) system to conduct metabolomics analysis on patient blood samples.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cardiovascular adverse events
Cardiovascular adverse events includes Cardiovascular-related death, non-fatal myocardial infarction, non-fatal stroke, repeat revascularization, rehospitalization for heart failure.
- Cardiovascular events related to mortality: This includes 1) cardiovascular death; 2) death caused by stroke; 3) death resulting from cardiovascular surgery; 4) death from other cardiovascular causes.
- Cardiovascular death: During the follow-up period, this refers to death directly associated with documented myocardial infarction, heart failure, or arrhythmia. It also includes death events where the cause is unclear and not attributed to any other underlying conditions.
- Repeat revascularization is any unplanned repeat revascularization of either a target vessel or non-target vessel or CABG;
Measured: 12 month follow-up
Incidence of Renal composite endpoint event
Renal composite endpoint event includes renal failure, renal-related death, or a decrease in eGFR >40% from baseline (confirmed by a second test 4 weeks later).
- Renal failure: End-stage kidney disease (ESKD) or eGFR persistently below 15 ml/min/1.73 m².
- End-stage kidney disease: Receiving renal replacement therapy (RRT), including hemodialysis/peritoneal dialysis, for more than 3 months, or undergoing kidney transplantation. Acute kidney injury (AKI) events leading to dialysis and death are also considered end-stage kidney disease (ESKD) events.
- Renal-related death: Meeting both of the following criteria: 1) The patient died during the follow-up period; 2) Despite the need for renal replacement therapy (RRT) due to their condition, it was not received；3）No other clear cause of death.
Measured: 12 month follow-up
Secondary outcomes (3)
Incidence of All-cause mortality
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: 12 month follow-up
Incidence of Repeat revascularization
Repeat revascularization is any unplanned repeat revascularization of either a target vessel or non-target vessel or CABG.
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 posted25 Apr 2024
- Study start1 Apr 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- Prospective
- Enrolment
- 470 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
- Zheng Jingang, MD, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383208
- Sponsor's protocol ID
- 2024-ZF-13
- Acronym
- CRUISE-MET
- Status last verified
- Apr 2024
- First submitted
- 21 Apr 2024
- Last updated
- 25 Apr 2024
- 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 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular-Renal Adverse oUtcome rIsk aSsessment systEm for Coronary Heart Disease Complicated With Chronic Kidney Disease Based on Targeted Lipid METabolomics
- ClinicalTrials.gov ID
- NCT06383208
- Acronym / sponsor ID
- CRUISE-MET / 2024-ZF-13
- Keywords
- Chronic Kidney Diseases, Coronary Heart Disease, Lipid Metabolism Disorders, Cardiovascular-Renal adverse prognosis, Metabolomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 25 Apr 2024 (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 heart disease (CHD) combined with chronic kidney disease (CKD) affects a substantial portion of the population and carries a significant disease burden, often leading to poor outcomes. Despite efforts to strictly control traditional risk factors, the efficacy in improving outcomes for patients with both CHD and CKD has been limited. Recent advancements in lipid metabolism research have identified new lipid metabolites associated with the occurrence and prognosis of CHD and CKD. Our preliminary trial has shown that levels of certain lipid metabolites, such as Cer(18:1/16:0), HexCer(18:1/16:0), and PI(18:0/18:1), are notably elevated in patients with CHD and reduced kidney function compared to those with relatively normal kidney function. This suggests that dysregulation of these non-traditional lipid metabolites may contribute to residual risk for adverse outcomes in these patients.
Furthermore, the emerging concept of "cardiovascular-kidney-metabolic syndrome" and the availability of new treatment options highlight the urgent need for a risk stratification tool tailored to modern management strategies and treatment goals to guide preventive measures effectively. To address this, we propose to conduct a prospective cohort study focusing on CHD combined with CKD. This study aims to comprehensively understand the clinical characteristics, diagnosis, treatment status, and cardiovascular-kidney prognosis in these patients. Through advanced metabolomics analysis, we seek to identify lipid metabolism profiles and non-traditional lipid metabolites associated with the progression of coronary artery disease in CHD-CKD patients. Leveraging clinical databases and metabolomics data, we will develop a robust risk prediction model for adverse cardiovascular-kidney outcomes, providing valuable guidance for clinical diagnosis, treatment decisions, and ultimately improving patient prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population of this study will be selected from China-Japan Friendship Hospital
Key inclusion criteria (4 listed)
- Age 18-80 years old;
- Diagnosed with CHD during hospitalization through coronary angiography, including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation acute coronary syndrome (NST-ACS), stable angina pectoris;
- Patients with clarified renal function status.;
- CKD is defined as meeting one of the following criteria, with a duration of more than 3 months: eGFR < 60 ml/min/1.73 m² or eGFR ≥ 60 ml/min/1.73 m² and urinary albumin-to-creatinine ratio (uACR) ≥ 30 mg/g;
Key exclusion criteria (9 listed)
- Pregnancy or lactation;
- Severe valve disease or severe mechanical complications requiring surgical intervention;
- Severe psychiatric illness or other reasons that impede follow-up compliance;
- Severe hematologic disorders or end-stage malignant tumors;
- Having undergone kidney transplantation or long-term maintenance dialysis;
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 |
|---|---|---|
| lipid metabolomicsExtract 4 milliliters of fasting peripheral venous blood from enrolled patients for targeted lipid metabolism metabolomics research. Utilize a liquid chromatography-tandem mass spectrometry (LC-MS/MS) system to conduct metabolomics analysis on patient blood samples. | Diagnostic test | – |
Primary outcome
Incidence of cardiovascular adverse events
Time frame: 12 month follow-up
Cardiovascular adverse events includes Cardiovascular-related death, non-fatal myocardial infarction, non-fatal stroke, repeat revascularization, rehospitalization for heart failure. 1. Cardiovascular events related to mortality: This includes 1) cardiovascular death; 2) death caused by stroke; 3) death resulting from cardiovascular surgery; 4) death from other cardiovascular causes. 2. Cardiovascular death: During the follow-up period, this refers to death directly associated with documented myocardial infarction, heart failure, or arrhythmia. It also includes death events where the cause is unclear and not attributed to any other underlying conditions. 3. Repeat revascularization is any unplanned repeat revascularization of either a target vessel or non-target vessel or CABG;
Incidence of Renal composite endpoint event
Time frame: 12 month follow-up
Renal composite endpoint event includes renal failure, renal-related death, or a decrease in eGFR >40% from baseline (confirmed by a second test 4 weeks later). 1. Renal failure: End-stage kidney disease (ESKD) or eGFR persistently below 15 ml/min/1.73 m². 2. End-stage kidney disease: Receiving renal replacement therapy (RRT), including hemodialysis/peritoneal dialysis, for more than 3 months, or undergoing kidney transplantation. Acute kidney injury (AKI) events leading to dialysis and death are also considered end-stage kidney disease (ESKD) events. 3. Renal-related death: Meeting both of the following criteria: 1) The patient died during the follow-up period; 2) Despite the need for renal replacement therapy (RRT) due to their condition, it was not received；3）No other clear cause of death.
3 secondary outcomes
Incidence of All-cause mortality
Time frame: 12 month follow-up
Incidence of Repeat revascularization
Time frame: 12 month follow-up
Incidence of bleeding
Time frame: 12 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- 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.
Zheng Jingang, MD 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 Chronic Kidney Diseases and Coronary Heart 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 25 Apr 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen Qiang (+86 13882712184, dawangchen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cardiovascular adverse events (time frame: 12 month follow-up). 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 25 Apr 2024.