Clinical trial NCT05117424: CArdioMetabolism and Atherosclerotic PlaqUe progreSsion
Official title: The Impact of Cardiometabolic Factors on Coronary Artery and Cardiovascular Diseases: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Diabetes Mellitus, Type 2
Dyslipidemias
Obesity
Metabolic Syndrome
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Age 18-80 years
* Established coronary artery disease or metabolic disorders, including:

  1. 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
  2. Prediabetes
  3. Obesity
  4. Chronic kidney disease
  5. Hyperuricemia
  6. Dyslipidemia

Exclusion Criteria:

* 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

Primary outcomes:
measure: Coronary plaque progression
timeFrame: 12 months
measure: Coronary lesion severity
timeFrame: 12 months
Secondary outcomes:
measure: Coronary plaque characteristics
timeFrame: 12 months
measure: Cardiovascular events
timeFrame: up to 5 years
Other outcomes:
measure: Diabetic complications
timeFrame: up to 5 years
measure: Glycated modifications of lipoproteins
timeFrame: up to 2 years
measure: Lipoprotein function assessment
timeFrame: up to 2 years
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Study officials:
affiliation: Ruijin Hospital, Shanghai Jiaotong School of Medicine
name: Lin Lu, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: Ruijin Hospital, Shanghai Jiaotong School of Medicine
name: Fenghua Ding, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Ruijin Hospital, Shanghai Jiaotong School of Medicine
name: Ruiyan Zhang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: