Ignite Creation Date:
2024-05-06 @ 8:58 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02868723
Status:
UNKNOWN
Last Update Posted:
2018-09-06
First Post:
2016-06-30
Brief Title:
PROspective Study to OPTimize thE HEALTH of Patients With TIAs Transient Ischemic Attacks and Stroke Admitted to the Hamad General Hospital
Sponsor:
Hamad Medical Corporation
Organization:
Hamad Medical Corporation
Study Overview
Official Title:
PROspective Study to OPTimize thE HEALTH of Patients With TIAS Transient Ischemic Attack and Stroke Admitted to the Hamad General Hospital
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMOTE-HEALTH
Brief Summary:
This will be a prospective randomized 2 year study of patients admitted to the Hamad General Hospital HGH and the Stroke Prevention Clinic with a diagnosis of ischemic stroke IS and Transit ischemic attacks TIAs After signing of the informed consent forms and initial evaluation and investigations all patients enrolled in the two arms study arm and control arm of the study will be followed for one year monthly visits for the first three months followed by visits three months until completion of study total of 6 follow up visits and the pre-specified investigations repeated at the one year follow up In one arm the control group the patients will be offered best risk factor management strategies as currently being practiced by stroke specialists at HGH in Qatar And in the second the subject group arm with assistance of a nurse-practitioner and pharmacist the investigators will make aggressive attempts to meet to target defined risk factors and have the evaluations and investigations completed as in the initial year cohort All patients will have risk factor stratification according the Framingham Risk Score FRS and the change in score measured over timeThe primary objective will be to determine if an approach that utilizes a comprehensive strategy results in a significantly outcome A clinically meaningful difference in the blood pressure BP and lipid control of 10 between the aggressively managed versus patients treated with the standard of care will require minimum of 200 patients in each group alpha error set at 005 and beta error at 020 power 80 to be recruited over 1 year and followed for one year total study duration 2 years
All patients will have screening magnetic resonance imaging MRI including gradient echo GRE sequence carotid 3D Doppler measurement of plaque volume and PAD assessments C-reactive protein CRP and evaluation for protein urea at baseline These studies will be repeated in 1 year at the time of exit from the study The co-primary objective would be to monitor progression or regression of plaque build-up on 3D Doppler imaging of the carotid arteries between the two cohorts The investigators hypothesize that aggressive management of vascular risk factors to recommended target levels will lead to better vascular health Compared to current practice comprehensive and coordinated approach at preventive measures will lead to more patients with better control of blood pressure and lipid levels Improved risk factor management will result in slowing of atherosclerosis and its downstream effects which will be measurable on sophisticated blood and imaging testing Clinically this will translate into fewer hospital re-admissions
All patients will have screening magnetic resonance imaging MRI including gradient echo GRE sequence carotid 3D Doppler measurement of plaque volume and PAD assessments C-reactive protein CRP and evaluation for protein urea at baseline These studies will be repeated in 1 year at the time of exit from the study The co-primary objective would be to monitor progression or regression of plaque build-up on 3D Doppler imaging of the carotid arteries between the two cohorts The investigators hypothesize that aggressive management of vascular risk factors to recommended target levels will lead to better vascular health Compared to current practice comprehensive and coordinated approach at preventive measures will lead to more patients with better control of blood pressure and lipid levels Improved risk factor management will result in slowing of atherosclerosis and its downstream effects which will be measurable on sophisticated blood and imaging testing Clinically this will translate into fewer hospital re-admissions
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None