Circle of Willis; Aneurysm, Congenital, RupturedCOWNCT06751420
Circle of Willis Variants in Nepali Population Evaluated in TOF MR Angiography
An observational study of Circle of Willis; Aneurysm, Congenital, Ruptured, run by Grande International Hospital, Nepal at 1 site in Nepal.
Trial summary
The brain, though it constitutes only 2% of total body weight, receives 20% of the cardiac output. Blood supply to the brain comes from two major pairs of arteries: the anterior carotid arteries and the posterior vertebral arteries, which form an important collateral network. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Circle of Willis; Aneurysm, Congenital, Ruptured
- What is being tested?
- Magnetic Resonance Imaging
- How many people
- 383 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jul 2024to 20 Dec 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients of all gender and age 18 and above
Who may be able to join
- adult patients (18+ years) with high-quality, three-dimensional time-of-flight MR angiography (TOF-MRA) imaging that clearly visualizes the Circle of Willis (CoW) and is performed for neurological assessments, such as headache or transient ischemic attacks.
Who cannot join
- patients with incomplete or poor-quality imaging, prior neurosurgical interventions, or significant vascular pathologies (e.g., aneurysms, arteriovenous malformations, severe atherosclerosis) that could distort natural CoW anatomy. Additionally, images with motion artifacts and cases with missing essential demographic or clinical information are excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring Variants of Circle of Willis Through 3 Dimensional Time-of-Flight Magnetic Resonance Angiography Imaging: A Retrospective Cross Section Study
The brain, though it constitutes only 2% of total body weight, receives 20% of the cardiac output. Blood supply to the brain comes from two major pairs of arteries: the anterior carotid arteries and the posterior vertebral arteries, which form an important collateral network. This network ensures that blood flow is maintained even if one of the arteries is obstructed. In 1664, Sir Thomas Willis first described this system, which was later named the "Circle of Willis" (COW) after him. Normally, there is little blood mixing between the branches of the circle, but during blockages in the main arteries, these collaterals can activate to maintain cerebral perfusion. The COW consists of an anterior and posterior portion. The anterior portion, supplied by the carotid arteries and their branches, and the posterior portion, formed by the vertebrobasilar system, provide critical blood flow to the brain. The key arteries involved in the COW include the internal carotid arteries (ICAs), anterior cerebral arteries (ACAs), anterior communicating artery (ACom), posterior cerebral arteries (PCAs), basilar artery (BA), and posterior communicating arteries (PComs). Anatomical variations in the COW are common, with a complete arterial circle being rare. Studies have documented a range of normal variants of the COW, which are likely to arise during vasculogenesis. Magnetic resonance imaging (MRI), using the non-invasive time of flight (TOF) technique, is a cost-effective and contrast-free method for visualizing the COW in three dimensions, making it preferable to conventional angiography.
The variants of COW and diameters of arteries of COW are of clinical importance given its critical role in brain blood supply. Understanding CoW variants can reveal predispositions to conditions like stroke and aneurysms. This research will provide prevalence data on CoW configurations, aiding diagnostic and treatment strategies for cerebrovascular diseases, and may offer insights into vascular development influences.
Read the detailed description
A study from Nepal conducted by Sharma et al.(1) investigated anatomical variations of the Circle of Willis (CoW) in the Nepalese population using 3D Time-of-Flight Magnetic Resonance Angiography (TOF-MRA). Among 118 subjects, only 46.6% exhibited the typical CoW configuration, with the most common variation being the absence or hypoplasia of the posterior communicating artery (PCOM), particularly the right PCOM (13.6% of cases). The findings suggest that morphological variations in CoW are common in Nepal, similar to global studies. Notably, women were more likely to present variant configurations than men, though no age-related trends in CoW morphology were observed. A study similar to our was done by Kızılgöz et al.(2) in Turkish population. This study enrolled 867 patients who had undergone MR angiography (MRA) to assess the Circle of Willis (CoW). Using three-dimensional time-of-flight MRA images, the researchers re-evaluated vessel diameters across all CoW components and classified CoW variations. They also analyzed how vessel calibers and CoW integrity related to gender and age groups. The study had a higher proportion of female participants, with an average age of 48. Type A was the most frequent variation in both anterior (75.78%) and posterior (53.98%) circulations. In the anterior circulation, types G and H were also common, while types E and D were the second and third most frequent in the posterior CoW, respectively. Females generally had smaller calibers in both ICAs, both P1s, and the BA compared to males. In patients with a complete CoW, the diameters of the BA and both P1 segments were lower, while the left PCom diameter was significantly larger. There was a notable variation by sex and age in the distribution of complete, partially complete, and incomplete CoW configurations. These findings on vessel calibers in complete, partial, and incomplete CoWs suggest that further research is needed, and meta-analyses with other studies could provide insights into CoW morphology. A study from India by Naveen et al.(3) examined CoW configurations in a South Indian population using TOF-MRA on 300 subjects. They found that only 16.6% had a complete CoW, with the most frequent variation being hypoplasia or absence of PCOM, observed predominantly in the posterior circulation. Incomplete CoW configurations were more common in older adults, with significant differences between age and sex groups. These findings highlight the CoW's role as a collateral pathway and its potential impact on cerebrovascular health. In Norway, Hindenes et al.(4) studied CoW variants in a large population using 3D TOF-MRA. They identified 47 unique configurations, with the complete CoW variant found in only 11.9% of cases. The study revealed that missing posterior communicating arteries were most common and associated with older age, indicating reduced collateral capacity. No significant sex differences were noted. This study underscores the CoW's variability and the effect of aging on its structure, emphasizing the clinical significance of collateral pathways in cerebrovascular health. Another study done by Diljohn et al. in Trinidian population showed complete Circle of Willis (CoW) in 24.3% of participants, with a higher occurrence in younger individuals (≤45 years) and Afro-Trinidadians. No gender preference for a complete CoW was identified. The most frequent variations in the CoW were a hypoplastic anterior communicating artery (8.6%, n=13) and bilateral aplastic posterior communicating arteries (18.4%, n=28) in the anterior and posterior segments, respectively.
- Being tested
- Magnetic Resonance Imaging
- Keywords
- Circle of Willis, Time Of Flight Magnetic Resonance Angiogram, Brain
- Medical subject headings
- Aneurysm, Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDiagnostic test
Magnetic Resonance Imaging Time Of Flight Angiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of different type of anterior and posterior circulation
Prevalence of different type of anterior and posterior circulation in Nepali population
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Jul 2024
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circle of Willis; Aneurysm, Congenital, RupturedStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grande International Hospital, Nepal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PRAJWAL DAHAL, Grande International Hospital, Nepal
- Investigators
- PRAJWAL DAHAL, MD, Principal investigator, Grande International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751420
- Sponsor's protocol ID
- 11/2024
- Other IDs
- GIH
- Acronym
- COW
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 27 Dec 2024
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Variants of Circle of Willis Through 3 Dimensional Time-of-Flight Magnetic Resonance Angiography Imaging: A Retrospective Cross Section Study
- ClinicalTrials.gov ID
- NCT06751420
- Acronym / sponsor ID
- COW / 11/2024
- Keywords
- Circle of Willis, Time Of Flight Magnetic Resonance Angiogram, Brain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- Grande International Hospital, NepalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 27 Dec 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.
The brain, though it constitutes only 2% of total body weight, receives 20% of the cardiac output. Blood supply to the brain comes from two major pairs of arteries: the anterior carotid arteries and the posterior vertebral arteries, which form an important collateral network. This network ensures that blood flow is maintained even if one of the arteries is obstructed. In 1664, Sir Thomas Willis first described this system, which was later named the "Circle of Willis" (COW) after him. Normally, there is little blood mixing between the branches of the circle, but during blockages in the main arteries, these collaterals can activate to maintain cerebral perfusion. The COW consists of an anterior and posterior portion. The anterior portion, supplied by the carotid arteries and their branches, and the posterior portion, formed by the vertebrobasilar system, provide critical blood flow to the brain. The key arteries involved in the COW include the internal carotid arteries (ICAs), anterior cerebral arteries (ACAs), anterior communicating artery (ACom), posterior cerebral arteries (PCAs), basilar artery (BA), and posterior communicating arteries (PComs). Anatomical variations in the COW are common, with a complete arterial circle being rare. Studies have documented a range of normal variants of the COW, which are likely to arise during vasculogenesis. Magnetic resonance imaging (MRI), using the non-invasive time of flight (TOF) technique, is a cost-effective and contrast-free method for visualizing the COW in three dimensions, making it preferable to conventional angiography.
The variants of COW and diameters of arteries of COW are of clinical importance given its critical role in brain blood supply. Understanding CoW variants can reveal predispositions to conditions like stroke and aneurysms. This research will provide prevalence data on CoW configurations, aiding diagnostic and treatment strategies for cerebrovascular diseases, and may offer insights into vascular development influences.
Detailed description
A study from Nepal conducted by Sharma et al.(1) investigated anatomical variations of the Circle of Willis (CoW) in the Nepalese population using 3D Time-of-Flight Magnetic Resonance Angiography (TOF-MRA). Among 118 subjects, only 46.6% exhibited the typical CoW configuration, with the most common variation being the absence or hypoplasia of the posterior communicating artery (PCOM), particularly the right PCOM (13.6% of cases). The findings suggest that morphological variations in CoW are common in Nepal, similar to global studies. Notably, women were more likely to present variant configurations than men, though no age-related trends in CoW morphology were observed. A study similar to our was done by Kızılgöz et al.(2) in Turkish population. This study enrolled 867 patients who had undergone MR angiography (MRA) to assess the Circle of Willis (CoW). Using three-dimensional time-of-flight MRA images, the researchers re-evaluated vessel diameters across all CoW components and classified CoW variations. They also analyzed how vessel calibers and CoW integrity related to gender and age groups. The study had a higher proportion of female participants, with an average age of 48. Type A was the most frequent variation in both anterior (75.78%) and posterior (53.98%) circulations. In the anterior circulation, types G and H were also common, while types E and D were the second and third most frequent in the posterior CoW, respectively. Females generally had smaller calibers in both ICAs, both P1s, and the BA compared to males. In patients with a complete CoW, the diameters of the BA and both P1 segments were lower, while the left PCom diameter was significantly larger. There was a notable variation by sex and age in the distribution of complete, partially complete, and incomplete CoW configurations. These findings on vessel calibers in complete, partial, and incomplete CoWs suggest that further research is needed, and meta-analyses with other studies could provide insights into CoW morphology. A study from India by Naveen et al.(3) examined CoW configurations in a South Indian population using TOF-MRA on 300 subjects. They found that only 16.6% had a complete CoW, with the most frequent variation being hypoplasia or absence of PCOM, observed predominantly in the posterior circulation. Incomplete CoW configurations were more common in older adults, with significant differences between age and sex groups. These findings highlight the CoW's role as a collateral pathway and its potential impact on cerebrovascular health. In Norway, Hindenes et al.(4) studied CoW variants in a large population using 3D TOF-MRA. They identified 47 unique configurations, with the complete CoW variant found in only 11.9% of cases. The study revealed that missing posterior communicating arteries were most common and associated with older age, indicating reduced collateral capacity. No significant sex differences were noted. This study underscores the CoW's variability and the effect of aging on its structure, emphasizing the clinical significance of collateral pathways in cerebrovascular health. Another study done by Diljohn et al. in Trinidian population showed complete Circle of Willis (CoW) in 24.3% of participants, with a higher occurrence in younger individuals (≤45 years) and Afro-Trinidadians. No gender preference for a complete CoW was identified. The most frequent variations in the CoW were a hypoplastic anterior communicating artery (8.6%, n=13) and bilateral aplastic posterior communicating arteries (18.4%, n=28) in the anterior and posterior segments, respectively.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of all gender and age 18 and above
Key inclusion criteria (1 listed)
- adult patients (18+ years) with high-quality, three-dimensional time-of-flight MR angiography (TOF-MRA) imaging that clearly visualizes the Circle of Willis (CoW) and is performed for neurological assessments, such as headache or transient ischemic attacks.
Key exclusion criteria (1 listed)
- patients with incomplete or poor-quality imaging, prior neurosurgical interventions, or significant vascular pathologies (e.g., aneurysms, arteriovenous malformations, severe atherosclerosis) that could distort natural CoW anatomy. Additionally, images with motion artifacts and cases with missing essential demographic or clinical information are excluded.
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 |
|---|---|---|
| Magnetic Resonance ImagingMagnetic Resonance Imaging Time Of Flight Angiography | Diagnostic test | – |
Primary outcome
Prevalence of different type of anterior and posterior circulation
Time frame: 6 months
Prevalence of different type of anterior and posterior circulation in Nepali population
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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.
PRAJWAL DAHAL, MD principal investigator
Grande International Hospital
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 Circle of Willis; Aneurysm, Congenital, Ruptured, run by Grande International Hospital, Nepal at 1 site in Nepal.
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: finished, as of the sponsor's last update on 27 Dec 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 Nepal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of different type of anterior and posterior circulation (time frame: 6 months). 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 27 Dec 2024.