AtherosclerosisNCT06221618
Evaluation of Vascular Structure in Elderly Using High-frequency Ultrasound and Construction of a Multimodal Risk Assessment System for Cardiovascular Diseases: a Multicenter Study
An observational study of Atherosclerosis and Stroke, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Stroke, Coronary Disease
- What is being tested?
- High-frequency carotid arteries ultrasound, CCTA, Cranial MRA
- How many people
- 8,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Mei Zhang
Jinan, Shandong
Mei Zhang, Phd, +86-18560086629, daixh@vip.sina.com
Mingjun Xu, Phd, +86-18560086569, xmj223@163.com
About this study
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
- Being tested
- High-frequency carotid arteries ultrasound, CCTA, Cranial MRA
- Keywords
- Stroke, Coronary heart disease, Risk assessment, Multimodality imaging, Cardiovascular diseases
- Medical subject headings
- Atherosclerosis, Stroke, Coronary Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-frequency carotid arteries ultrasound, CCTA, Cranial MRAOther
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
| Study group | Role | What they receive |
|---|---|---|
| Coronary heart disease cohort | CCTA required for coronary heart disease cohort Receives: Other: High-frequency carotid arteries ultrasound, CCTA, Cranial MRA | |
| Stroke cohort | Cranial MRA required for stroke cohort Receives: Other: High-frequency carotid arteries ultrasound, CCTA, Cranial MRA | |
| Normal control group | Healthy elderly without coronary heart disease and stroke (≥ 60 years old) Receives: Other: High-frequency carotid arteries ultrasound, CCTA, Cranial MRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular and cerebrovascular composite endpoint events
- Myocardial infarction
- Cardiovascular death
- Resuscitation with cardiac arrest
- Revascularization
- Stroke.
Measured: 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 outcomes (1)
Progression of the vascular lesions
- Increase of vascular intima thickness
- Increase of vascular media thickness
- Plaque progression
- Increase of vascular stenosis
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start15 Feb 2024 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Xuanwu Hospital, Beijing, Shenzhen People's Hospital, Shenzhen University, The Fourth Affiliated Hospital of China Medical University
- Responsible party
- Sponsor
- Investigators
- Mei Zhang, PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221618
- Sponsor's protocol ID
- KYLL-202212(XZ)-015-1
- Status last verified
- Dec 2023
- First submitted
- 18 Dec 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lusis AJ. Atherosclerosis. Nature. 2000 Sep 14;407(6801):233-41. doi: 10.1038/35025203.
PubMed 11001066Schoenhagen P, Vince DG. Intravascular photoacoustic tomography of coronary atherosclerosis: riding the waves of light and sound. J Am Coll Cardiol. 2014 Jul 29;64(4):391-3. doi: 10.1016/j.jacc.2014.05.018. No abstract available.
PubMed 25060375Ruengsakulrach P, Sinclair R, Komeda M, Raman J, Gordon I, Buxton B. Comparative histopathology of radial artery versus internal thoracic artery and risk factors for development of intimal hyperplasia and atherosclerosis. Circulation. 1999 Nov 9;100(19 Suppl):II139-44. doi: 10.1161/01.cir.100.suppl_2.ii-139.
PubMed 10567293
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vascular Structure in Elderly Using High-frequency Ultrasound and Construction of a Multimodal Risk Assessment System for Cardiovascular Diseases: a Multicenter Study
- ClinicalTrials.gov ID
- NCT06221618
- Acronym / sponsor ID
- KYLL-202212(XZ)-015-1
- Conditions
- Atherosclerosis, Stroke, Coronary Disease
- Keywords
- Stroke, Coronary heart disease, Risk assessment, Multimodality imaging, Cardiovascular diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Xuanwu Hospital, Beijing, Shenzhen People's Hospital, Shenzhen University, The Fourth Affiliated Hospital of China Medical University
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Coronary heart disease cohort | – | Other: High-frequency carotid arteries ultrasound, CCTA, Cranial MRACCTA required for coronary heart disease cohort |
| Stroke cohort | – | Other: High-frequency carotid arteries ultrasound, CCTA, Cranial MRACranial MRA required for stroke cohort |
| Normal control group | – | Other: High-frequency carotid arteries ultrasound, CCTA, Cranial MRAHealthy elderly without coronary heart disease and stroke (≥ 60 years old) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-frequency carotid arteries ultrasound, CCTA, Cranial MRACCTA 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 | Other | Coronary heart disease cohort, Normal control group, Stroke cohort |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Background: PubMed 11001066Lusis AJ. Atherosclerosis. Nature. 2000 Sep 14;407(6801):233-41. doi: 10.1038/35025203.
- Background: PubMed 25060375Schoenhagen P, Vince DG. Intravascular photoacoustic tomography of coronary atherosclerosis: riding the waves of light and sound. J Am Coll Cardiol. 2014 Jul 29;64(4):391-3. doi: 10.1016/j.jacc.2014.05.018. No abstract available.
- Background: PubMed 10567293Ruengsakulrach P, Sinclair R, Komeda M, Raman J, Gordon I, Buxton B. Comparative histopathology of radial artery versus internal thoracic artery and risk factors for development of intimal hyperplasia and atherosclerosis. Circulation. 1999 Nov 9;100(19 Suppl):II139-44. doi: 10.1161/01.cir.100.suppl_2.ii-139.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei Zhang, PhD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Stroke, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mei Zhang, PhD (+86-18560086629, daixh@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06221618, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.