Vulnerable Atherosclerotic PlaqueNCT03849521
Plaque Calcium Characterization and Ruptured Plaques
An observational study of Vulnerable Atherosclerotic Plaque, run by Li Min at 1 site in China.
Trial summary
Recently, ultrashort echo time (UTE) MR, which allows detection of the ultrashort T2 components, has been used to image plaque calcification in ex vivo carotid and coronary arteries. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vulnerable Atherosclerotic Plaque
- What is being tested?
- MRI
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 31 Dec 2025
- How long will I take part?
- 3 Years
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Sixty patients referred for carotid endarterectomy or stent were prospectively enrolled.Patients gave written informed consent to participate in this Institutional Review Board-approved human subjects investigation. Clinical assessment at baseline using both patient interview and chart review documented presence or absence of symptoms (symptomatic and asymptomatic patients, respectively) attributable to the carotid artery disease, such as transient ischemic attack or cerebrovascular accident in the distribution of the diseased artery and absence of other source of embolism.
Who may be able to join
- Patients referred for carotid endarterectomy or stent were prospectively enrolled.
Who cannot join
- Patients with ferromagnetic metal, active implants such as pacemakers, aneurysm clips, known claustrophobia, and those who were unable to provide informed consent were excluded from enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Min Li
Jinan, Shandong, 250031
Min Li, M.D., 13953176057, liminyingxiang@163.com
About this study
Official title: In Vivo Atherosclerotic Plaque Calcium Characterization for Predicting Ruptured Plaques
Recently, ultrashort echo time (UTE) MR, which allows detection of the ultrashort T2 components, has been used to image plaque calcification in ex vivo carotid and coronary arteries. The results demonstrated that UTE images are able to identify plaque calcification and enables accurate quantification of calcium volumes. However, gadolinium-based contrast agents during in vivo CMR could not be performed in these ex vivo study. Agnese et al. believed that calcifications with 18F-NaF PET uptake might be considered to represent dormant areas where on-going mineralization, which is a key sign to identify and localise ruptured and high risk coronary plaque. We, therefore, hypothesize that enhanced carotid calcification presented by UTE MR may be a critical sign for symptomatic patients.
In this study, we will investigate the feasibility of enhanced UTE MR in human carotid arteries in vivo. Furthermore, we analyzed the correlation between UTE MR and microcalcification of in the carotid plaques. Based on the diagnostic ability of enhanced UTE MR for microcalcification, we will investigate the potential of enhanced calcification to distinguish symptomatic from asymptomatic patients with carotid atherosclerosis and research the prognostic ability of enhance calcufication in UTE MR.
Read the detailed description
Atherosclerosis, characterized by the accumulation of lipids and inflammatory cells in the large arteries, is one of the most common causes of morbidity and mortality in developed and developing countries. Atherosclerotic plaque rupture-induced thrombosis or obstruction of artery is the most important cause for the sudden and unpredictable onset of acute artery stroke. Our understanding of specific characteristics of the vulnerable atherosclerotic plaque has been enhanced by retrospective pathological studies, which have identified common phenotypic features of the atherosclerotic plaque most prone to rupture and trigger thrombotic events. A thin fibrous cap, a large lipid core, high macrophage count, and intraplaque hemorrhage have all been identified as markers of the so-called "vulnerable" plaque being related to a higher stroke risk.
Calcification of atherosclerotic lesions was long thought to be an age - related, passive process where a combination of high local concentrations of phosphates and phosphatidylserines from necrotic cells and an absence of calcification inhibitors results in the precipitation of calcium phosphate particles. Recently increasingly data has revealed that atherosclerotic calcification is a more active process, involving complex signaling pathways and bone-like genetic programs. The distinction of early or active calcification as a destabilizing process and late calcification as a more stable state has also been supported by histological studies. This has lead to interest in characterizing early stages of calcification metabolically by making use of the positron emission tomography (PET)/CT imaging of atherosclerosis using 18F-sodium fluoride (18F-NaF), which has recently been reported having the potential to distinguish dormant areas with on-going mineralization and quiescent atherosclerotic calcium. Nevertheless, PET/CT is an expensive and a radioactive examination, which is not appropriate for large-scale screening or serial follow-up studies.
MRI is ideal for serial studies of lesions of atherosclerosis over time because it is noninvasive and is superior to other imaging modalities in distinguishing soft tissue contrast. In conventional gradient echo based MRI with TEs in the 1 to 2 ms range, however, the very short T2 relaxation time of solid calcifications on the order of some μs causes almost complete signal cancellation, which may cause significant overestimation of the calcified region and could not provide information about calcium density. Moreover, the low or zero signal from calcium with short T2 means that there is little opportunity to manipulate conspicuity by using different pulse sequences or contrast agents.
Recently, ultrashort echo time (UTE) MR, which allows detection of the ultrashort T2 components, has been used to image plaque calcification in ex vivo carotid and coronary arteries. The results demonstrated that UTE images are able to identify plaque calcification and enables accurate quantification of calcium volumes. However, gadolinium-based contrast agents during in vivo CMR could not be performed in these ex vivo study. Agnese et al. believed that calcifications with 18F-NaF PET uptake might be considered to represent dormant areas where on-going mineralization, which is a key sign to identify and localise ruptured and high risk coronary plaque. We, therefore, hypothesize that enhanced carotid calcification presented by UTE MR may be a critical sign for symptomatic patients.
In this study, we will investigate the feasibility of enhanced UTE MR in human carotid arteries in vivo. Furthermore, we analyzed the correlation between UTE MR and microcalcification of in the carotid plaques. Based on the diagnostic ability of enhanced UTE MR for microcalcification, we will investigate the potential of enhanced calcification to distinguish symptomatic from asymptomatic patients with carotid atherosclerosis and research the prognostic ability of enhance calcufication in UTE MR.
- Conditions
- Vulnerable Atherosclerotic Plaque
- Being tested
- MRI
- Keywords
- Atherosclerosis, Calcium, MR
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Enhanced carotid calcification presented by UTE MR.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic group | Group with asymptomatic patients with carotid atherosclerosis. Receives: Diagnostic Test: MRI | |
| Symptomatic group | Group with symptomatic patients with carotid atherosclerosis. Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms attributable to the carotid artery disease
Clinical assessment at baseline using both patient interview and chart review documented presence or absence of symptoms (symptomatic and asymptomatic patients, respectively) attributable to the carotid artery disease, such as transient ischemic attack or cerebrovascular accident in the distribution of the diseased artery and absence of other source of embolism.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Jun 2019 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulnerable Atherosclerotic PlaqueStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Li Min
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Min, Jinan Military General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849521
- Sponsor's protocol ID
- 201703
- Status last verified
- Feb 2019
- First submitted
- 20 Feb 2019
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Atherosclerotic Plaque Calcium Characterization for Predicting Ruptured Plaques
- ClinicalTrials.gov ID
- NCT03849521
- Acronym / sponsor ID
- 201703
- Conditions
- Vulnerable Atherosclerotic Plaque
- Keywords
- Atherosclerosis, Calcium, MR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Li MinUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Feb 2019 (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.
Recently, ultrashort echo time (UTE) MR, which allows detection of the ultrashort T2 components, has been used to image plaque calcification in ex vivo carotid and coronary arteries. The results demonstrated that UTE images are able to identify plaque calcification and enables accurate quantification of calcium volumes. However, gadolinium-based contrast agents during in vivo CMR could not be performed in these ex vivo study. Agnese et al. believed that calcifications with 18F-NaF PET uptake might be considered to represent dormant areas where on-going mineralization, which is a key sign to identify and localise ruptured and high risk coronary plaque. We, therefore, hypothesize that enhanced carotid calcification presented by UTE MR may be a critical sign for symptomatic patients.
In this study, we will investigate the feasibility of enhanced UTE MR in human carotid arteries in vivo. Furthermore, we analyzed the correlation between UTE MR and microcalcification of in the carotid plaques. Based on the diagnostic ability of enhanced UTE MR for microcalcification, we will investigate the potential of enhanced calcification to distinguish symptomatic from asymptomatic patients with carotid atherosclerosis and research the prognostic ability of enhance calcufication in UTE MR.
Detailed description
Atherosclerosis, characterized by the accumulation of lipids and inflammatory cells in the large arteries, is one of the most common causes of morbidity and mortality in developed and developing countries. Atherosclerotic plaque rupture-induced thrombosis or obstruction of artery is the most important cause for the sudden and unpredictable onset of acute artery stroke. Our understanding of specific characteristics of the vulnerable atherosclerotic plaque has been enhanced by retrospective pathological studies, which have identified common phenotypic features of the atherosclerotic plaque most prone to rupture and trigger thrombotic events. A thin fibrous cap, a large lipid core, high macrophage count, and intraplaque hemorrhage have all been identified as markers of the so-called "vulnerable" plaque being related to a higher stroke risk.
Calcification of atherosclerotic lesions was long thought to be an age - related, passive process where a combination of high local concentrations of phosphates and phosphatidylserines from necrotic cells and an absence of calcification inhibitors results in the precipitation of calcium phosphate particles. Recently increasingly data has revealed that atherosclerotic calcification is a more active process, involving complex signaling pathways and bone-like genetic programs. The distinction of early or active calcification as a destabilizing process and late calcification as a more stable state has also been supported by histological studies. This has lead to interest in characterizing early stages of calcification metabolically by making use of the positron emission tomography (PET)/CT imaging of atherosclerosis using 18F-sodium fluoride (18F-NaF), which has recently been reported having the potential to distinguish dormant areas with on-going mineralization and quiescent atherosclerotic calcium. Nevertheless, PET/CT is an expensive and a radioactive examination, which is not appropriate for large-scale screening or serial follow-up studies.
MRI is ideal for serial studies of lesions of atherosclerosis over time because it is noninvasive and is superior to other imaging modalities in distinguishing soft tissue contrast. In conventional gradient echo based MRI with TEs in the 1 to 2 ms range, however, the very short T2 relaxation time of solid calcifications on the order of some μs causes almost complete signal cancellation, which may cause significant overestimation of the calcified region and could not provide information about calcium density. Moreover, the low or zero signal from calcium with short T2 means that there is little opportunity to manipulate conspicuity by using different pulse sequences or contrast agents.
Recently, ultrashort echo time (UTE) MR, which allows detection of the ultrashort T2 components, has been used to image plaque calcification in ex vivo carotid and coronary arteries. The results demonstrated that UTE images are able to identify plaque calcification and enables accurate quantification of calcium volumes. However, gadolinium-based contrast agents during in vivo CMR could not be performed in these ex vivo study. Agnese et al. believed that calcifications with 18F-NaF PET uptake might be considered to represent dormant areas where on-going mineralization, which is a key sign to identify and localise ruptured and high risk coronary plaque. We, therefore, hypothesize that enhanced carotid calcification presented by UTE MR may be a critical sign for symptomatic patients.
In this study, we will investigate the feasibility of enhanced UTE MR in human carotid arteries in vivo. Furthermore, we analyzed the correlation between UTE MR and microcalcification of in the carotid plaques. Based on the diagnostic ability of enhanced UTE MR for microcalcification, we will investigate the potential of enhanced calcification to distinguish symptomatic from asymptomatic patients with carotid atherosclerosis and research the prognostic ability of enhance calcufication in UTE MR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic group | – | Diagnostic Test: MRIGroup with asymptomatic patients with carotid atherosclerosis. |
| Symptomatic group | – | Diagnostic Test: MRIGroup with symptomatic patients with carotid atherosclerosis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Sixty patients referred for carotid endarterectomy or stent were prospectively enrolled.Patients gave written informed consent to participate in this Institutional Review Board-approved human subjects investigation. Clinical assessment at baseline using both patient interview and chart review documented presence or absence of symptoms (symptomatic and asymptomatic patients, respectively) attributable to the carotid artery disease, such as transient ischemic attack or cerebrovascular accident in the distribution of the diseased artery and absence of other source of embolism.
Key inclusion criteria (1 listed)
- Patients referred for carotid endarterectomy or stent were prospectively enrolled.
Key exclusion criteria (1 listed)
- Patients with ferromagnetic metal, active implants such as pacemakers, aneurysm clips, known claustrophobia, and those who were unable to provide informed consent were excluded from enrollment.
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 |
|---|---|---|
| MRIEnhanced carotid calcification presented by UTE MR. | Diagnostic test | Asymptomatic group, Symptomatic group |
Primary outcome
Symptoms attributable to the carotid artery disease
Time frame: 3 years
Clinical assessment at baseline using both patient interview and chart review documented presence or absence of symptoms (symptomatic and asymptomatic patients, respectively) attributable to the carotid artery disease, such as transient ischemic attack or cerebrovascular accident in the distribution of the diseased artery and absence of other source of embolism.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- 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.
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 Vulnerable Atherosclerotic Plaque, run by Li Min 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 1 inclusion and 1 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 21 Feb 2019. 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 Zhen Yang, M.D. (18615658796, taianyangzhen@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms attributable to the carotid artery disease (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2019.