Asymptomatic Intracranial Atherosclerotic Disease in Pakistanis

NCT02072876 | Completed DMC

• 1 other identifier: 5D43TW008660-03
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Intracranial Atherosclerosis

Keywords

Stroke; Asymptomatic Intracranial Atherosclerotic Disease; Lifestyle and socio-economic risk factors; Clinical predictors

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Associated Brain MRI Findings with Intracranial Stenosis

  MRA Once , Over One Year

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (2)

Aga Khan University

Karachi, Sindh, 7400, Pakistan

Location

Akuh,Duhs

Karachi, Sindh, Pakistan

Location

Related Publications (2)

• 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.

  PMID: 25825629 DERIVED

• 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.

  PMID: 25124284 DERIVED

MeSH Terms

Conditions

Intracranial Arteriosclerosis; Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Ayeesha K Kamal, MBBS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Neurology,Director Stroke Fellowship Program

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: February 27, 2014
• Study Start: March 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 28, 2014

Record last verified: 2014-02

Locations

PA (2)