Asymptomatic Intracranial Atherosclerotic Disease in Pakistanis (AICAD)
Primary Purpose
Intracranial Atherosclerosis
Status
Completed
Phase
Locations
Pakistan
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Intracranial Atherosclerosis focused on measuring Stroke, Asymptomatic Intracranial Atherosclerotic Disease, Lifestyle and socio-economic risk factors, Clinical predictors
Eligibility 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
Sites / Locations
- Aga Khan University
- Akuh,Duhs
Arms of the Study
Arm 1
Arm 2
Arm Type
Arm Label
Asymptomatic ICAD on MRI Absent
Asymptomatic ICAD Present on MRI
Arm Description
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.
Those who are negative for Stroke Symptoms on QVSFS, Questionnaire to Verify Stroke Free Status, yet have evidence of ICAD on MRI
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Associated Brain MRI Findings with Intracranial Stenosis
Brain volume reduction, Central and Peripheral Atrophy Periventricular Lucencies Silent Brain Infarcts
Full Information
NCT ID
NCT02072876
First Posted
February 25, 2014
Last Updated
February 27, 2014
Sponsor
Aga Khan University
1. Study Identification
Unique Protocol Identification Number
NCT02072876
Brief Title
Asymptomatic Intracranial Atherosclerotic Disease in Pakistanis
Acronym
AICAD
Official Title
Asymptomatic Intracranial Atherosclerotic Disease: Prevalence, Clinical and Lifestyle Determinants in Urban Pakistan
Study Type
Observational
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Atherosclerosis
Keywords
Stroke, Asymptomatic Intracranial Atherosclerotic Disease, Lifestyle and socio-economic risk factors, Clinical predictors
7. Study Design
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Asymptomatic ICAD on MRI Absent
Arm Description
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.
Arm Title
Asymptomatic ICAD Present on MRI
Arm Description
Those who are negative for Stroke Symptoms on QVSFS, Questionnaire to Verify Stroke Free Status, yet have evidence of ICAD on MRI
Primary Outcome Measure Information:
Title
Distribution and Degree of Asymptomatic Intracranial Stenosis
Description
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.
Time Frame
MRA , Once , Over One Year
Secondary Outcome Measure Information:
Title
Associated Brain MRI Findings with Intracranial Stenosis
Description
Brain volume reduction, Central and Peripheral Atrophy Periventricular Lucencies Silent Brain Infarcts
Time Frame
MRA Once , Over One Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Study Population Description
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.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayeesha K Kamal, MBBS
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University
City
Karachi
State/Province
Sindh
ZIP/Postal Code
7400
Country
Pakistan
Facility Name
Akuh,Duhs
City
Karachi
State/Province
Sindh
Country
Pakistan
12. IPD Sharing Statement
Citations:
PubMed Identifier
25825629
Citation
Kamal AK, Majeed F, Pasha O, Islam M, Azam I, Ilyas MS, Hussain M, Masood K, Ahmed B, Nazir S, Sajjad Z, Kasner SE. Study protocol: asymptomatic intracranial atherosclerotic disease in pakistanis. J Vasc Interv Neurol. 2015 Feb;8(1):27-35.
Results Reference
derived
PubMed Identifier
25124284
Citation
Kamal AK, Majeed F, Pasha O, Rehman H, Islam M, Azam I, Ilyas MS, Hussain M, Masood K, Ahmed B, Nazir S, Sajjad Z, Kasner SE. Clinical, lifestyle, socioeconomic determinants and rate of asymptomatic intracranial atherosclerosis in stroke free Pakistanis. BMC Neurol. 2014 Aug 15;14:155. doi: 10.1186/s12883-014-0155-6.
Results Reference
derived
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Asymptomatic Intracranial Atherosclerotic Disease in Pakistanis
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