Prospective Cohort Study of Panvascular Disease

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.

Study Overview

• Status: Active, not recruiting
• Conditions: ASCVD
• Intervention / Treatment: Other: no different intervention between the two cohort.

• Study Type: Observational
• Enrollment (Estimated): 50000

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Second Affiliated Hospital, School of Medicine, Zhejiang University
    • Hangzhou, Zhejiang, China, 310000
      • Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This is a prospective cohort study with 50,000 patients.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ASCVD cohort; The patient had atherosclerosis in 2 or more vessels	Other: no different intervention between the two cohort.; no different intervention between the two cohort.
healthy cohort; The patient had no atherosclerosis in vessels	Other: no different intervention between the two cohort.; no different intervention between the two cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cardiovascular adverse events	1, 3, and 5 years follow-up
Cardiovascular mortality	1, 3, and 5 years follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of receiving vascular revascularization	1, 3, and 5 years follow-up
Readmission rate for vascular reasons	1, 3, and 5 years follow-up

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2024
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Estimated): March 6, 2024

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-1194

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No