CArdioMetabolism and Atherosclerotic PlaqUe progreSsion

Recruiting

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

• Registration Number: NCT05117424
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2021-10-19
• Study First Submitted QC: 2021-11-01
• Study First Posted: 2021-11-11
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coronary plaque progression	12 months	Assessed by coronary angiography and QCA
Coronary lesion severity	12 months	Assessed by coronary angiography and QCA

Secondary Outcome Measures

Name	Time	Method
Coronary plaque characteristics	12 months	Assessed by intravascular imaging (IVUS or OCT)
Cardiovascular events	up to 5 years	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.)

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China