Asymptomatic Intracranial Atherosclerotic Disease in Pakistanis

The incidence of stroke has increased by 100% in the last four decades in developing countries like Pakistan. Intracranial atherosclerotic disease (ICAD) is the most frequent causative subtype of ischemic stroke in the world including Pakistan. ICAD is progressive narrowing of the arteries at the base of the brain due to atherosclerosis. After a stroke from ICAD, recurrence rate is highest in any sub-type of stroke, up to 28% with limited therapeutic options. Therefore, it is imperative to delineate the determinants of asymptomatic ICAD prior to stroke. Investigators hypothesized that there is at least a 20% difference in the proportion of clinical, life-style (dietary, physical activity, obesity, smoking and stress/depression), and socio-economic predictors of asymptomatic ICAD than those with no ICAD.

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Key information

Conditions

Intracranial Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Intracranial Arteriosclerosis Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aga Khan University, Karachi, Sindh, Pakistan

About this study

Stroke is a major emerging cause of adult disability and the 3rd leading non-communicable cause of mortality in the world . With half of the world's population living in Asia, stroke epidemiology and its risk factor determination is important globally. The changes in population demographics and continuing industrialization in Asia have also led to a change in the epidemiology of stroke sub-types . Among the ischemic stroke sub-types, Intracranial Atherosclerotic disease is now emerging as the most prevalent vascular cause of stroke with high prevalence in Asian, African and Hispanic individuals .

Patients with ICAD are at a significant risk for recurrent stroke, with a risk as high as 25% in the first two years . Rate of recurrent stroke also varies by the location of the affected artery. Risk factor management is extremely important for the primary and secondary prevention of stroke in Asia as it is in Western countries. With the changing demographics and relatively fewer cost effective treatment modalities available, particularly for resource poor countries like Pakistan, it is imperative to delineate the clinical as well as lifestyle risk factors at an earlier asymptomatic stage to prevent future life-threatening consequences.

Therefore the primary objective of this study is to determine the clinical, lifestyle, dietary and psycho-social determinants of asymptomatic Intracranial Atherosclerotic disease (ICAD) and its other associated Brain MRI findings namely brain volume reduction, silent brain infarcts, and peri-ventricular hyper intensities in clinically normal adults with ICAD on MRI Brain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult Pakistani men and women ≥ 18years getting MRI brain for any indication other than stroke.
Permanent residents of Pakistan for at least 1 year.
No prior history of stroke which was confirmed by screening with Questionnaire for verifying stroke free status (QVSFS).
Able to give written informed consent.

Exclusion criteria

QVSFS +ve.
Severe disability, life expectancy less than 6 months at enrollment.
Patients in whom MRI prolongation for 5 minutes can be harmful for the patient (Anesthesia, claustrophobia, sedation etc.).
Any clear contraindications to MRI, like pacemakers, metallic valves

Treatment and study plan

Primary outcomes

Distribution and Degree of Asymptomatic Intracranial Stenosis

Time frame: MRA , Once , Over One Year

This was defined as any artery (Internal Carotid Artery ICA, Middle Cerebral Artery MCA,Anterior Cerebral Artery ACA,Posterior Cerebral Artery PCA, Basilar Artery BA, and Vertebral Artery VA) having >25% stenosis on MRA. An internationally standardized ( WASID) equation was used to calculate the degree of stenosis.

Percent stenosis= [1- (Dstenosis/D normal)*100], where D Stenosis is the diameter of the artery at the site of the most severe stenosis, and D normal= diameter of the proximal normal artery.

Secondary outcomes

Associated Brain MRI Findings with Intracranial Stenosis

Time frame: MRA Once , Over One Year

Brain volume reduction, Central and Peripheral Atrophy Periventricular Lucencies Silent Brain Infarcts

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

Asymptomatic Intracranial Atherosclerotic Disease: Prevalence, Clinical and Lifestyle Determinants in Urban Pakistan

Acronym: AICAD

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Feb 27, 2014
Registry last updated: Feb 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed