Atherosclerosis of ArteryNCT04303351
Periodontitis and Atherosclerotic-related Arterial Stenosis
An observational study of Atherosclerosis of Artery, run by Guangzhou University of Traditional Chinese Medicine.
Trial summary
This study aimed to evaluate the association between periodontitis and atherosclerosis of the cerebral vasculature in the Chinese population. Read more about this study
- Who is it for?
- Ages 18 to 98 years
- Conditions the study is for
- Atherosclerosis of Artery
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to Apr 2022
- 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 18 to 98 years
- All sexes
- Adult, Older adult
Study population: Study population are people who underwent cerebral angiography at Guangdong Provincial Hospital of Chinese Medicine from April 2020 to April 2022 and meat the inclusion and exclusion criteria
Who may be able to join
- subjects who underwent cerebral angiography at Guangdong Provincial Hospital of Chinese Medicine from April 2020 to December 2021
- subjects who voluntarily participated in this study and provided informed consent.
Who cannot join
- intracranial and extracranial artery stenosis caused by vascular inflammation, systemic connective tissue disease, and muscle fibre structure hypoplasia
- inability to cooperate with the investigation
- intracranial aneurysm and cerebral arteriovenous malformation confirmed by cerebral angiography
- receipt of periodontal treatment in the previous 24 months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Relationship Between Periodontitis and Atherosclerotic-related Arterial Stenosis in the Chinese Population
This study aimed to evaluate the association between periodontitis and atherosclerosis of the cerebral vasculature in the Chinese population.
Read the detailed description
Periodontitis has been demonstrated as a risk factor for ischaemic stroke in several clinical studies. Atherosclerosis of the cerebral vasculatureis an important pathological process causing ischaemic stroke. The investigator's study aims to investigate the relationship between tooth loss(used as a surrogate of periodontal disease) and atherosclerotic-related arterial stenosis in the Chinese population. An estimated 1,000 participants that underwent cerebral angiography at Guangdong Provincial Hospital of Chinese Medicine between Apirl 2020 and January 2022 will be recruited in this trial. Arterial stenosis features of each participants will be collected based on the results of digital subtraction angiography (DSA). The missing teeth counts of each participant will be collected and some of them will recieved comprehensive periodontal examination. Besides, blood samples will be collected in order to investigate the serum inflammatory markers(CRP,WBC,albumin,IL-6,IL-10). The relationship between tooth loss and atherosclerotic-related arterial stenosis will be analysed by regression models adjusted for conventional risk factors (sex,age, obesity,smoking,Alcohol drinking,diabetes,hypertension,hyperuricaemia,hyperhomocysteinaemia)
- Conditions
- Atherosclerosis of Artery
- Keywords
- arterial stenosis, periodontitis, atherosclerosis, risk factors
- Medical subject headings
- Periodontitis, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 0-9 missing teeth | participants with 0-9 missing teeth | |
| 10-19 missing teeth | participants with 10-19 missing teeth | |
| 23-31 missing teeth | participants with 23-31 missing teeth | |
| Edentulous | participants with no teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between atherosclerotic-related stenosis in different brain arteries and tooth loss categories
The arteries of the brains will be partitioned into the following segments: common carotid artery (CCA), internal carotid arteries (ICA, C1-C7), the external carotid artery (ECA), the anterior cerebral artery (ACA, A1-A2), the middle cerebral artery (MCA, M1-M2), the posterior cerebral artery (PCA), the basilar artery (BA), the vertebral artery (VA,V1-V4) and the subclavicular artery (SUB) .The chi-square test and Fisher's exact test will be used, as appropriate, to estimate the relationship between tooth loss and stenosis distributed in different branches
Measured: 1 day
Secondary outcomes (1)
The relationship between the severity of artery stenosis and tooth loss categories
The degree of vascular stenosis will be categorized into five group: no stenosis, mild stenosis, moderate stenosis, severe stenosis and occlusion. Ordinal logistic regression will be performed to analyse the relationship between the tooth loss categories and the degrees of artery stenosis.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study startApr 2020 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerosis of ArteryStudies 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
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303351
- Sponsor's protocol ID
- ZF2019-010
- Status last verified
- Mar 2020
- First submitted
- 8 Mar 2020
- Last updated
- 11 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Periodontitis and Atherosclerotic-related Arterial Stenosis in the Chinese Population
- ClinicalTrials.gov ID
- NCT04303351
- Acronym / sponsor ID
- ZF2019-010
- Conditions
- Atherosclerosis of Artery
- Keywords
- arterial stenosis, periodontitis, atherosclerosis, risk factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 11 Mar 2020 (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.
This study aimed to evaluate the association between periodontitis and atherosclerosis of the cerebral vasculature in the Chinese population.
Detailed description
Periodontitis has been demonstrated as a risk factor for ischaemic stroke in several clinical studies. Atherosclerosis of the cerebral vasculatureis an important pathological process causing ischaemic stroke. The investigator's study aims to investigate the relationship between tooth loss(used as a surrogate of periodontal disease) and atherosclerotic-related arterial stenosis in the Chinese population. An estimated 1,000 participants that underwent cerebral angiography at Guangdong Provincial Hospital of Chinese Medicine between Apirl 2020 and January 2022 will be recruited in this trial. Arterial stenosis features of each participants will be collected based on the results of digital subtraction angiography (DSA). The missing teeth counts of each participant will be collected and some of them will recieved comprehensive periodontal examination. Besides, blood samples will be collected in order to investigate the serum inflammatory markers(CRP,WBC,albumin,IL-6,IL-10). The relationship between tooth loss and atherosclerotic-related arterial stenosis will be analysed by regression models adjusted for conventional risk factors (sex,age, obesity,smoking,Alcohol drinking,diabetes,hypertension,hyperuricaemia,hyperhomocysteinaemia)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0-9 missing teeth | – | –participants with 0-9 missing teeth |
| 10-19 missing teeth | – | –participants with 10-19 missing teeth |
| 23-31 missing teeth | – | –participants with 23-31 missing teeth |
| Edentulous | – | –participants with no teeth |
Who may qualify
- Ages
- 18 to 98 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study population are people who underwent cerebral angiography at Guangdong Provincial Hospital of Chinese Medicine from April 2020 to April 2022 and meat the inclusion and exclusion criteria
Key inclusion criteria (2 listed)
- subjects who underwent cerebral angiography at Guangdong Provincial Hospital of Chinese Medicine from April 2020 to December 2021
- subjects who voluntarily participated in this study and provided informed consent.
Key exclusion criteria (4 listed)
- intracranial and extracranial artery stenosis caused by vascular inflammation, systemic connective tissue disease, and muscle fibre structure hypoplasia
- inability to cooperate with the investigation
- intracranial aneurysm and cerebral arteriovenous malformation confirmed by cerebral angiography
- receipt of periodontal treatment in the previous 24 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The relationship between atherosclerotic-related stenosis in different brain arteries and tooth loss categories
Time frame: 1 day
The arteries of the brains will be partitioned into the following segments: common carotid artery (CCA), internal carotid arteries (ICA, C1-C7), the external carotid artery (ECA), the anterior cerebral artery (ACA, A1-A2), the middle cerebral artery (MCA, M1-M2), the posterior cerebral artery (PCA), the basilar artery (BA), the vertebral artery (VA,V1-V4) and the subclavicular artery (SUB) .The chi-square test and Fisher's exact test will be used, as appropriate, to estimate the relationship between tooth loss and stenosis distributed in different branches
1 secondary outcome
The relationship between the severity of artery stenosis and tooth loss categories
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis of Artery, run by Guangzhou University of Traditional Chinese Medicine.
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 2 inclusion and 4 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 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Jianwen Guo, MD (13724899379, jianwen_guo@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between atherosclerotic-related stenosis in different brain arteries and tooth loss categories (time frame: 1 day). 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 11 Mar 2020.