Coronary Artery DiseaseCAMPUSNCT05117424
CArdioMetabolism and Atherosclerotic PlaqUe progreSsion
An observational study of Coronary Artery Disease and Diabetes Mellitus, Type 2, run by Ruijin Hospital at 1 site in China.
Trial summary
Systematic metabolic diseases are closely related to prevalence and progression of atherosclerosis. This prospective cohort consecutively enrolls patients with coronary artery disease compliacted with metabolic abnormalities such as diabtetes, prediabetes, obesity, chronic kidney disease and hyperuricemia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Diabetes Mellitus, Type 2, Dyslipidemias
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Dec 2025
- How long will I take part?
- 5 Years
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is a single-center cohort study. Patients with metabolic disorders (as listed in eligibility criteria) and suspected coronary artery disease undergone coronary angiography at Ruijin Hospital, Shanghai, China are consecutively enrolled.
Who may be able to join
- Age 18-80 years
- Established coronary artery disease or metabolic disorders, including:
- Type 2 diabetes diagnosed by one of the following criteria:
- HbA1c >/= 6.5% Fasting plasma glucose >/= 7.0 mmol/l (confirmed) 2h plasma glucose value during OGTT >/= 11.1 mmol/l Already receiving glucose-lowering agents
- Prediabetes
- Obesity
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- Chronic kidney disease
- Hyperuricemia
- Dyslipidemia
Who cannot join
- Severe liver failure (Child-Pugh grade B to C)
- Severe anemia (hemoglobin < 60g/L)
- Familial hypercholesterolemia
- Active malignant tumor
- Active autoimmune diseases on corticosteroids
- Acute or chronic infection
- Life expectancy < 1 year
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200025
Jian Li, BS, 0086 021 64370045, ruijincrc@126.com
Ruiyan Zhang, M.D., Ph.D.
About this study
Official title: The Impact of Cardiometabolic Factors on Coronary Artery and Cardiovascular Diseases: a Prospective Cohort Study
Systematic metabolic diseases are closely related to prevalence and progression of atherosclerosis. This prospective cohort consecutively enrolls patients with coronary artery disease compliacted with metabolic abnormalities such as diabtetes, prediabetes, obesity, chronic kidney disease and hyperuricemia.
Read the detailed description
CArdioMetabolism and Atherosclerotic PlaqUe progreSsion (CAMPUS) study is a single center, prospective cohort study to investigate the impact of cardiometabolic factors on coronary diseases. This study consecutively enrolls patients with coronary artery diseases complicatied with metabolic abnormalities, including diabetes, prediabetes, obesity, chronic kidney disease and hyperuricemia.
- Conditions
- Coronary Artery Disease, Diabetes Mellitus, Type 2, Dyslipidemias, Obesity, Metabolic Syndrome
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus, Type 2, Dyslipidemias, Obesity, Metabolic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary plaque progression
Assessed by coronary angiography and QCA
Measured: 12 months
Coronary lesion severity
Assessed by coronary angiography and QCA
Measured: 12 months
Secondary outcomes (2)
Coronary plaque characteristics
Assessed by intravascular imaging (IVUS or OCT)
Measured: 12 months
Cardiovascular events
The incidence of MACCE (major adverse cardio and cerebral vascular events), lesion associated events (target lesion myocardial infarction, target lesion faliure, target vessel revascularization, etc.)
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Jan 2017
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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 Ruijin 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
- 3,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RUIYAN ZHANG, Ruijin Hospital
- Investigators
- Lin Lu, M.D., Ph.D., Study director, Ruijin Hospital, Shanghai Jiaotong School of MedicineFenghua Ding, M.D., Ph.D., Study chair, Ruijin Hospital, Shanghai Jiaotong School of MedicineRuiyan Zhang, M.D., Ph.D., Principal investigator, Ruijin Hospital, Shanghai Jiaotong School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117424
- Sponsor's protocol ID
- RJH-CAMPUS
- Acronym
- CAMPUS
- Status last verified
- Aug 2024
- First submitted
- 19 Oct 2021
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Cardiometabolic Factors on Coronary Artery and Cardiovascular Diseases: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05117424
- Acronym / sponsor ID
- CAMPUS / RJH-CAMPUS
- Conditions
- Coronary Artery Disease, Diabetes Mellitus, Type 2, Dyslipidemias, Obesity, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Nov 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.
Systematic metabolic diseases are closely related to prevalence and progression of atherosclerosis. This prospective cohort consecutively enrolls patients with coronary artery disease compliacted with metabolic abnormalities such as diabtetes, prediabetes, obesity, chronic kidney disease and hyperuricemia.
Detailed description
CArdioMetabolism and Atherosclerotic PlaqUe progreSsion (CAMPUS) study is a single center, prospective cohort study to investigate the impact of cardiometabolic factors on coronary diseases. This study consecutively enrolls patients with coronary artery diseases complicatied with metabolic abnormalities, including diabetes, prediabetes, obesity, chronic kidney disease and hyperuricemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a single-center cohort study. Patients with metabolic disorders (as listed in eligibility criteria) and suspected coronary artery disease undergone coronary angiography at Ruijin Hospital, Shanghai, China are consecutively enrolled.
Key inclusion criteria (9 listed)
- Age 18-80 years
- Established coronary artery disease or metabolic disorders, including:
- HbA1c >/= 6.5% Fasting plasma glucose >/= 7.0 mmol/l (confirmed) 2h plasma glucose value during OGTT >/= 11.1 mmol/l Already receiving glucose-lowering agents
Key exclusion criteria (7 listed)
- Severe liver failure (Child-Pugh grade B to C)
- Severe anemia (hemoglobin < 60g/L)
- Familial hypercholesterolemia
- Active malignant tumor
- Active autoimmune diseases on corticosteroids
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
Coronary plaque progression
Time frame: 12 months
Assessed by coronary angiography and QCA
Coronary lesion severity
Time frame: 12 months
Assessed by coronary angiography and QCA
2 secondary outcomes
Coronary plaque characteristics
Time frame: 12 months
Cardiovascular events
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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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.
Lin Lu, M.D., Ph.D. study director
Ruijin Hospital, Shanghai Jiaotong School of Medicine
Fenghua Ding, M.D., Ph.D. study chair
Ruijin Hospital, Shanghai Jiaotong School of Medicine
Ruiyan Zhang, M.D., Ph.D. principal investigator
Ruijin Hospital, Shanghai Jiaotong School of Medicine
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 Diabetes Mellitus, Type 2, run by Ruijin 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 9 inclusion and 7 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 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoqun Wang, M.D., Ph.D. (+86 21 13651839760, xiaoqun_wang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary plaque progression (time frame: 12 months). 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 6 Aug 2024.