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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Nepal1 site
  • Tokha Road, Dhapasi

    Kathmandu, Bagmati, 44600

Other trials in Nepal

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.

  1. 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.

  1. First posted27 Dec 2024
  2. Study start1 Jul 2024
  3. Primary completion20 Dec 2024
  4. Study completion20 Dec 2024

Resources

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)
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

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.

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