CArdioMetabolism and Atherosclerotic PlaqUe progreSsion

Obesity Clinical Trial

— CAMPUS  

Official title:

The Impact of Cardiometabolic Factors on Coronary Artery and Cardiovascular Diseases: a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05117424
• Other study ID #: RJH-CAMPUS
• Status: Recruiting
• Start date: November 1, 2018
• Est. completion date: March 31, 2024

Study information

• Verified date: February 2023
• Source: Ruijin Hospital
• Contact: Xiaoqun Wang, M.D., Ph.D.
• Phone: +86 21 13651839760
• Email: xiaoqun_wang[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18-80 years

• 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

• Chronic kidney disease

• Hyperuricemia

• Receiving coronary angiography for clinically suspected coronary artery disease

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Diabetes Mellitus, Type 2
• Dyslipidemias
• Metabolic Syndrome
• Obesity

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diabetic complications	Prevalence of diabetic complications, including peripheral artery disease, retinopathy, nephropathy, encephalopathy.	up to 5 years
Other	Glycated modifications of lipoproteins	Glycated modifications of lipoproteins in patients, such as ApoA-I glycation.	up to 2 years
Other	Lipoprotein function assessment	HDL functions, including reverse cholesterol transport assessed by cholesterol efflux capacity, anti-inflammatory function, and anti-oxidation function	up to 2 years
Primary	Coronary plaque progression	Assessed by coronary angiography and QCA	12 months
Primary	Coronary lesion severity	Assessed by coronary angiography and QCA	12 months
Secondary	Coronary plaque characteristics	Assessed by intravascular imaging (IVUS or OCT)	12 months
Secondary	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.)	up to 5 years