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Asymptomatic Intracranial Atherosclerotic Disease in Pakistanis (AICAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02072876
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : February 28, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Ayeesha Kamran Kamal, Aga Khan University

Brief 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.

Condition or disease
Intracranial Atherosclerosis

Detailed 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.


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Study Type : Observational
Actual Enrollment : 200 participants
Official Title: Asymptomatic Intracranial Atherosclerotic Disease: Prevalence, Clinical and Lifestyle Determinants in Urban Pakistan
Study Start Date : March 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Group/Cohort
Asymptomatic ICAD on MRI Absent
Those who test negative on QVSFS, Questionnaire to Verify Stroke Free Status, and do not have ICAD on MRI. They are clinically and biologically free of disease.
Asymptomatic ICAD Present on MRI
Those who are negative for Stroke Symptoms on QVSFS, Questionnaire to Verify Stroke Free Status, yet have evidence of ICAD on MRI



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study recruited all adult Pakistani patients ≥ 18 yrs., with no previous clinical history of stroke, (negative on QVSFS; Questionnaire to Verify Stroke Free Status), presenting to the two tertiary care centers for MRI Brain for indications other than stroke.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072876


Locations
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Pakistan
Aga Khan University
Karachi, Sindh, Pakistan, 7400
Akuh,Duhs
Karachi, Sindh, Pakistan
Sponsors and Collaborators
Aga Khan University
Investigators
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Principal Investigator: Ayeesha K Kamal, MBBS Aga Khan University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Ayeesha Kamran Kamal, Associate Professor Neurology,Director Stroke Fellowship Program, Aga Khan University
ClinicalTrials.gov Identifier: NCT02072876     History of Changes
Other Study ID Numbers: 5D43TW008660-03 ( U.S. NIH Grant/Contract )
First Posted: February 27, 2014    Key Record Dates
Last Update Posted: February 28, 2014
Last Verified: February 2014
Keywords provided by Dr. Ayeesha Kamran Kamal, Aga Khan University:
Stroke
Asymptomatic Intracranial Atherosclerotic Disease
Lifestyle and socio-economic risk factors
Clinical predictors
Additional relevant MeSH terms:
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Intracranial Arteriosclerosis
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases