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

January 14, 2024 updated by: Qilu Hospital of Shandong University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

8000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mingjun Xu, Phd
  • Phone Number: +86-18560086569
  • Email: xmj223@163.com

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China
        • Mei Zhang
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mei Zhang, Phd
        • Sub-Investigator:
          • Minghua Yao, Phd
        • Sub-Investigator:
          • Yingqi Xing, Phd
        • Sub-Investigator:
          • Fajin Dong, Phd
        • Sub-Investigator:
          • Yabin Wang, Phd
        • Sub-Investigator:
          • Shuang Liu, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients come from the following hospitals:

  • Qilu Hospital of Shandong University,
  • Xuanwu Hospital of Capital Medical University,
  • Chinese PLA General Hospital
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • Shenzhen People's Hospital
  • The Fourth Affiliated Hospital of China Medical University.

Description

Inclusion Criteria:

  • Age ≥ 60 years
  • All patients had original ultrasound images of bilateral carotid arteries with DICOM format and arteriosclerosis clinical and laboratory data
  • Original data of CCTA or examination results in the baseline status are needed for CHD patients
  • Original data of intracranial artery MRA or examination results in the baseline status are needed for patients with ischemic stroke.

Exclusion Criteria:

  • Age is <60 years old
  • Severe cardiac insufficiency, New York Heart Association(NYHA) class IV and (or) left ventricular ejection fraction <30%
  • Uncontrollable severe hypertension (systolic blood pressure≥ 180 mmHg or diastolic blood pressure≥ 110 mmHg) or uncontrollable severe diabetes mellitus, i.e., diabetes mellitus complicated with acute complications (including diabetic ketoacidosis and hypertonic hyperglycemic nonketosis coma), or acute hyperglycemic state (random blood glucose> 16.7mmol/L and (or) blood ketone 1.0-3.0mmol/L) without acute complications
  • Severe valvular disease (moderate regurgitation and / or stenosis in each valve)
  • Various cardiomyopathy caused by hypertrophic cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy, myocardial amyloidosis
  • Severe arrhythmia: persistent atrial fibrillation or atrial flutter, degree II 2 and above atrioventricular block, complete left bundle branch block
  • Severe hepatic and renal insufficiency (glutamate transaminase and / or glutamine transaminase> 3 times the upper limit of normal value, Blood creatinine> 134 μmol/L or an estimated glomerular filtration rate of <60ml/min/1.73m2)
  • Severe chronic obstructive pulmonary disease or asthma
  • Severe non-cardiovascular disease (malignant tumor, thyroid disease, infection, connective tissue disease)
  • Mental retardation or mental disorders
  • Life expectancy <3 years due to various factors
  • Refusal to sign informed consent
  • Allergy to contrast agent should also be ruled out for patients undergoing CCTA for CHD.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Coronary heart disease cohort
CCTA required for coronary heart disease cohort
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
Stroke cohort
Cranial MRA required for stroke cohort
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
Normal control group
Healthy elderly without coronary heart disease and stroke (≥ 60 years old)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular and cerebrovascular composite endpoint events
Time Frame: From the date of enrollment until the date of the first recorded endpoint event or the date of the end of the study, up to 20 months
  • Myocardial infarction
  • Cardiovascular death
  • Resuscitation with cardiac arrest
  • Revascularization
  • Stroke.
From the date of enrollment until the date of the first recorded endpoint event or the date of the end of the study, up to 20 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression of the vascular lesions
Time Frame: From the date of enrollment until the date of the first recorded endpoint event or the date of the end of the study, up to 20 months
  • Increase of vascular intima thickness
  • Increase of vascular media thickness
  • Plaque progression
  • Increase of vascular stenosis
From the date of enrollment until the date of the first recorded endpoint event or the date of the end of the study, up to 20 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Collaborators

Chinese PLA General Hospital
Xuanwu Hospital, Beijing
Shenzhen People's Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
The Fourth Affiliated Hospital of China Medical University
Shenzhen University

Investigators

  • Principal Investigator: Mei Zhang, PhD, Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2024

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 18, 2023

First Submitted That Met QC Criteria

January 14, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Actual)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 14, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLL-202212(XZ)-015-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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