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NCT Number: NCT05117424

CArdioMetabolism and Atherosclerotic PlaqUe progreSsion

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Body Weight Cardiovascular Diseases Coronary Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Hyperinsulinism Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Metabolic Syndrome Myocardial Ischemia Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200025, China

Location status: Recruiting

Location contact

Fenghua Ding, M.D., Ph.D.

SUB_INVESTIGATOR

Jian Li, BS

CONTACT

[email protected]

0086 021 64370045

Lili Liu, M.E.

SUB_INVESTIGATOR

Lin Lu, M.D., Ph.D.

SUB_INVESTIGATOR

Ruiyan Zhang, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

Shuo Feng, M.D.

SUB_INVESTIGATOR

Xiaoqun Wang, M.D., Ph.D.

SUB_INVESTIGATOR

Ying Shen, M.D., Ph.D.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Chronic kidney disease
  • Hyperuricemia
  • 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

Treatment and study plan

Primary outcomes

  1. Coronary plaque progression

    Time frame: 12 months

    Assessed by coronary angiography and QCA

  2. Coronary lesion severity

    Time frame: 12 months

    Assessed by coronary angiography and QCA

Secondary outcomes

  1. Coronary plaque characteristics

    Time frame: 12 months

    Assessed by intravascular imaging (IVUS or OCT)

  2. Cardiovascular events

    Time frame: 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.)

Other outcomes

  1. Diabetic complications

    Time frame: up to 5 years

    Prevalence of diabetic complications, including peripheral artery disease, retinopathy, nephropathy, encephalopathy.

  2. Glycated modifications of lipoproteins

    Time frame: up to 2 years

    Glycated modifications of lipoproteins in patients, such as ApoA-I glycation.

  3. Lipoprotein function assessment

    Time frame: up to 2 years

    HDL functions, including reverse cholesterol transport assessed by cholesterol efflux capacity, anti-inflammatory function, and anti-oxidation function

Study contacts

Contact information is provided by the study sponsor or research team.

Shuo Feng, M.D.

CONTACT

[email protected]

+86 21 15921388296

Xiaoqun Wang, M.D., Ph.D.

CONTACT

[email protected]

+86 21 13651839760

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Acronym: CAMPUS

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Nov 11, 2021
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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