Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201911798073249 Date of Approval: 29/11/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Assessment of Cognitive Function in patients with extracranial and intracranial stenosis
Official scientific title Assessment of Cognitive Function in patients with extracranial and intracranial stenosis
Brief summary describing the background and objectives of the trial Intracranial stenosis ( ICS) has gained increasing attention due to its role in causing ischemic damage and hence cognitive dysfunction. Furthermore, a hight prevalence of ICS also observed in-vivo in vascular dementia compared to AD patients ( 53% vs 18%). Therefore , we will examine the association between ICS, ECS and cognitive impairement in a sample of Egyptian population. Our objectives will be: a )To assess the cognitive function in patients with extracranial and intracranial artery stenosis before and after ballooon angioplasty and stent insertion. b)To assess the prognosis ( by using NIHSS)in patients with extracranial and intracranial artery stenosis 3 months after ballooon angioplasty and stent insertion.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial balloon angioplasty and stent insertion in IC stenosis and EC stenosis
Anticipated trial start date 23/08/2017
Actual trial start date 23/08/2017
Anticipated date of last follow up 30/12/2019
Actual Last follow-up date 30/12/2019
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group balloon angioplasty and stent insertion in Iintracranial stenotic vessels 3 years We recruit 15 patient with only intracranial stenosis . Then we do balloon angioplasty and stent insertion in , and FU of prognosis and cognitive function before and 3 months after the procedure 15
Experimental Group balloon angioplasty and stent insertion drug eluting stent 3 years We recruit 15 patient with only extracranial stenosis . Then we do balloon angioplasty and stent insertion in , and FU of prognosis and cognitive function before and 3 months after the procedure 15
Control Group nothing just doing cognitive function with no follow up no intervention. Just doing cognitive function assessmne t and P300 30 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a) Patients with intracranial/extracraniial stenosis diagnosed by MRA/CTA or DSA, with or without history of stroke or TIA. b) Their ages are above 18 years old. a) Patients suffering any other causes of dementia than vascular dementia b)Patients suffering heart failure, respiratory failure, renal failure or liver cell failure ( metabolic causes of cognitive decline ) c) Patients with concomitant neurologic disorder potentially affecting cognitive function d)Patients with enduring mental illness. e) Patients with hemispheric stroke attributed to middle cerebral artery occlusion 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/08/2017 Ain Shams University Faculty of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
38 Abbasid - next Nour Mosque - Cairo Cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome improvement of prognosis and cognitive function or at least stopping the deterioration in cognitive function resulting from either intracranial or extracranial stenosis 3 months after the procedure
Secondary Outcome Balloon angioplasty and stent insertion plus medical therapy is superior to medical therapy alone 3 months after the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospitals Next 38 Abbasia, Nour Mosque, El-Mohamady, Al Waili, Cairo Governorate cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain Shams University Hospitals Next, 38 Abbasia, Nour Mosque, El-Mohamady, Al Waili, Cairo Cairo 11566 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Hospitals 38 Abbasid - next Nour Mosque - Cairo Cairo 11566 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed El Bokl Rehab City Cairo 11841 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Amr Zaki amrsaeed@med.asu.edu.eg 01010006721 makrm Ebid
City Postal code Country Position/Affiliation
Cairo 11765 Egypt Assistent Lecturer of Neurology in Ain Shams University Hospital
Role Name Email Phone Street address
Principal Investigator Nevine ElNahas nevineelnahas30@yahoo.com 01227910517 ELShorrok
City Postal code Country Position/Affiliation
Cairo 11837 Egypt Professor of Neurology in Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Ahmed ElBassiony ahmedelbassiony@gmail.com 01222132125 New CAiro
City Postal code Country Position/Affiliation
Cairo 11835 Egypt Professor of Neurology in Ain Shams University Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Our null hypothesis is that cerebral hypoperfusion whether due to intra-cranial or extra-cranial stenosis is associated with cognitive impairment , and that intervention by balloon angioplasty +/- stent insertion is associated with improvement of cerebral blood flow , hence halting the progression of the vascular dementia. Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information