NCT06221618

Evaluation of Vascular Structure in Elderly Using High-frequency Ultrasound and Construction of a Multimodal Risk Assessment System for Cardiovascular Diseases: a Multicenter Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 8,000 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

Coronary heart disease(CHD), stroke, and hypertension are major diseases that seriously affect human health.Pathologic changes in the arteries involved in the above diseases mainly occur in the intimal or medial layer of the arteries. Among them, cardiovascular and cerebrovascular diseases (CHD and stroke) have become the top two causes of death worldwide, with elderly patients accounting for the vast majority. CHD is an important cause of death, and atherosclerosis (AS) is the main pathology underlying it.AS predominantly occurs in the intima layer, and the use of high-resolution imaging techniques to visualize anatomical changes in the intima-media layer of the arteries alone is valuable for the study of AS. Coronary computed tomographic angiography (CCTA) and intracranial vascular magnetic resonance angiography (MRA) can clearly visualize coronary and intracranial arterial lesions, measure luminal stenosis and other important information, and provide a basis for diagnosis, treatment and prognosis of the disease. By integrating CCTA/MRA/Ultrasound multimodal imaging technology, investigators aim to develop a non-invasive CHD and stroke intelligent screening and evaluation system, which is bound to have great clinical and social value. This study is a national multi-center follow-up observational study, which is expected to collect and establish a database of clinical and imaging information of no less than 20,000 cases of elderly subjects. Some data is derived from the pre-established database (\>12,000 cases) in cooperative research centers, while additional data will be collected from the newly established prospective follow-up database. Investigators performed noninvasive high-frequency ultrasound to detect arterial vascular structural changes, vascular dynamics and other indicators based on the existing database and the newly established imaging database to explore the characteristics of carotid atherosclerosis changes and ultrasound monitoring methods in the elderly. Finally, investigators integrated clinical and multimodal noninvasive imaging information to construct a noninvasive imaging-based intelligent risk assessment system for CHD and stroke. Primary endpoint was the cardiovascular-complex endpoint event,including myocardial infarction, cardiovascular death, resuscitation with cardiac arrest, revascularization, and stroke. Secondary endpoint was vascular lesion progression, including increase of vascular intima thickness, increase of vascular media thickness, plaque progression, and increase of vascular stenosis. All enrolled patients were followed up every six months to record whether the primary endpoint and secondary endpoint events occurred and to record the time and type of occurrence.

Conditions

• Atherosclerosis
• Stroke
• Coronary Disease

Interventions

Type	Name	Description
OTHER	High-frequency carotid arteries ultrasound, CCTA, Cranial MRA	CCTA and carotid high-frequency ultrasound for all patients in the coronary heart disease cohort. Cranial MRA and carotid high-frequency ultrasound for all people in the stroke cohort.Carotid high-frequency ultrasound for all patients in the normal control group.All patients were treated optimally according to guidelines

Timeline

• Start date: 2024-02-15
• Primary completion: 2025-10-31
• Completion: 2025-12-31
• First posted: 2024-01-24
• Last updated: 2024-01-24

Locations

1 site across 1 country: China