Clinical trial NCT02868723: PROspective Study to OPTimize thE HEALTH of Patients With TIAs (Transient Ischemic Attacks) and Stroke Admitted to the Hamad General Hospital
Official title: PROspective Study to OPTimize thE HEALTH of Patients With TIAS (Transient Ischemic Attack) and Stroke Admitted to the Hamad General Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Transient Ischemic Attack (TIA)
Keywords: cerebrovascular disease
patient management
stroke management
prognosis
3D Carotid Doppler Imaging
Randomization
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2016-08-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 time.The 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 0.05 and beta error at 0.20, 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.


Eligibility criteria: Inclusion Criteria:

* ISCHEMIC STROKE OR TIA including ocular stroke such as Amaurosis Fugax, within the past year (not intracranial hemorrhage or due to trauma, malignancy or cardio-embolic related to structural heart disease)
* MEETS AT LEAST ONE OF THE FOLLOWING THREE CRITERIA:

  * systolic Bp\>140 mmHg but \<200 mmHg (at 24 HR from admission/if clinic visit 3 readings 5 minutes apart)
  * fasting LDL cholestrol \>2.0 (MEASURED WITHIN PREVIOUS 6 MONTH)
  * total: HDL cholestrol ratio \>4.0 (measured within previous 6 month)
* Willing to participate (by signing consent form)and willing to return for study-related scheduled follow up visits for one year from the time of enrollment into the study

Exclusion Criteria:

* Participation in concurrent interventional trial related to stroke or vascular disease
* Any condition, including foreshortened life-expectancy or severe comorbidities that would preclude treatment benefit or 12-month follow up.
* Institutionalized in a long term care facility
* Already on maximal therapy for risk factors:

  * On 3 ANTI HTN drugs at maximal dose (if htn is inclusion criteria)
  * On maximal dose of statin (if elevated LDL-cholesterol is inclusion criteria)
* CT or MRI shows evidence of primary intracranial hemorrhage or neoplasm
* Active coronary artery disease
* Severe Renal on hemo-dialysis(HD) or Severe Hepatic dysfunction
* Cognitive dysfunction severe enough to interfere with patients ability to give informed consent
* Severe systemic illness that will not allow for the patient to complete the one year trial
* History of intolerance to statins or commonly used anti-hypertensive medications(intolerance/contraindication to statin(if elevated LDL-c is the inclusion criteria)
* Unable to tolerate antiplatelet agents
* Decline of consent
* Reside outside Qatar
* Unable to participate (due cognition, mobility, language barrier)

Primary outcomes:
measure: Progression/regression of 3D plaque volume
timeFrame: one year
Secondary outcomes:
measure: Measurement of blood pressure
timeFrame: one year
measure: Measurement of Lipid levels
timeFrame: one year
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Corporation
Study officials:
affiliation: Hamad Medical Corporation
name: YAHIA Z BASHIER IMAM, MBBS,MRCP,MRCPE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Imam YZ, Mohamed MFH, Abdelmoneim MS, Santos M, Alkhawad N, Salam A, Amir N, Saqqur M, Muhammad A, Elsoutohy A, Kamran S, Akhtar N, Kiliyanni AS, Own A, Deleu D, Shuaib A. Prospective study to optimize the health of patients with TIAS (transient ischemic attack) and stroke admitted to the Hamad General Hospital. Medicine (Baltimore). 2020 Jul 10;99(28):e20694. doi: 10.1097/MD.0000000000020694.