Prospective Cohort Study of Panvascular Disease

ASCVD Clinical Trial

Official title:

Prospective Cohort Study of Panvascular Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06295861
• Other study ID #: 2023-1194
• Status: Active, not recruiting
• Start date: February 21, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: February 2024
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To construct a comprehensive big data platform for Chinese people with panvascular disease, and establish a Chinese panvascular disease oriented to guide treatment decisions Cohort and imaging, biological database; According to the clinical features, morphological structure, pathological characteristics of panvascularization, vascular age As the core of the evaluation, a standard evaluation system and a risk prediction model of intervention technology suitable for the diagnosis and treatment of patients with panvascular disease in China were established. Into the Further optimize the treatment strategies, protocols and clinical pathways for panvascular disease to improve patient prognosis and promote its application.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50000
• Est. completion date: December 31, 2028
• Est. primary completion date: November 30, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. Age =18 years old 2. Patients with panvascular disease: i.e., 2 or more of the following vascular diseases.

2.1 Coronary artery: 2.1.1 Coronary atherosclerotic heart disease: including acute coronary syndrome, stable angina, moderate or more stenosis of the coronary artery, history of myocardial infarction, history of coronary revascularization such as stent implantation or bypass grafting.

2.2. Cerebrovascular: 2.2.1 Intracranial atherosclerotic disease: including ischemic stroke, transient ischemic attack or moderate or more stenosis of the intracranial artery.

2.2.2 Cervical atherosclerotic disease: including carotid artery disease, vertebral artery disease.

2.3. Aorta: 2.3.1 Aortic atherosclerotic disease: including severe aortic plaque, aortic ulcer, aortic stenosis or atresia, aortic dissection, aortic aneurysm, etc.

2.4. Peripheral arteries: 2.4.1 Upper limb atherosclerotic disease: including subclavian artery, axillary artery, brachial artery and other sites.

Edition 2 January 25, 2024 2.4.2 Renal atherosclerotic disease 2.4.3 Mesenteric atherosclerotic disease 2.4.4 Lower limb atherosclerotic disease 3. Clinical data and biological samples are available 4. The subjects or their legal representatives were informed of the nature of the study and agreed to all terms of participation in the study, and signed the informed consent approved by the ethics committee of each clinical center.

Exclusion Criteria:

• 1. Currently undergoing treatment for malignant tumor (radiotherapy, chemotherapy, during surgery, etc.) 2. Current medical conditions requiring urgent treatment (this criterion is not excluded after the condition is stabilized): such as acute infection, hypertension crisis, diabetic ketoacidosis, aortic dissection, etc.

3. Current severe heart failure (NYHA class 4) 4. Current liver failure (ALT or AST = 5 times the upper limit of normal) or current renal failure (decreased renal function caused by any reason (defined as eGFR < 30mL/(min·1.73m2)) 5. Pregnant or lactating women, or women who plan to become pregnant during the study period 6. Current severe mental illness (except mild to moderate anxiety and depression) 7. Organ transplantation 8. Estimated survival time <3 years 9. Blood-borne infectious diseases: including HIV infection, AIDS, active hepatitis B, hepatitis C, etc.

10. Any condition considered inappropriate for participation in the study by the investigators.

Related Conditions & MeSH terms

• ASCVD

Intervention

Other:
• no different intervention between the two cohort.
no different intervention between the two cohort.

Locations

Country	Name	City	State
China	Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular adverse events		1, 3, and 5 years follow-up
Primary	Cardiovascular mortality		1, 3, and 5 years follow-up
Secondary	Rate of receiving vascular revascularization		1, 3, and 5 years follow-up
Secondary	Readmission rate for vascular reasons		1, 3, and 5 years follow-up