Asymptomatic Intracranial Atherosclerotic Disease in Pakistanis

Intracranial Atherosclerosis Clinical Trial

— AICAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02072876
• Other study ID #: 5D43TW008660-03
• Status: Completed
• Phase: N/A
• First received: February 25, 2014
• Last updated: February 27, 2014
• Start date: March 2013
• Est. completion date: June 2013

Study information

• Verified date: February 2014
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Atherosclerosis
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi	Sindh
Pakistan	Akuh,Duhs	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution and Degree of Asymptomatic Intracranial Stenosis	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.	MRA , Once , Over One Year	No
Secondary	Associated Brain MRI Findings with Intracranial Stenosis	Brain volume reduction, Central and Peripheral Atrophy Periventricular Lucencies Silent Brain Infarcts	MRA Once , Over One Year	No