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StrokePROMOTE-HEALTHNCT02868723

PROspective Study to OPTimize thE HEALTH of Patients With TIAs (Transient Ischemic Attacks) and Stroke Admitted to the Hamad General Hospital

A study testing Aggressive Management in people with Stroke and Transient Ischemic Attack (TIA), run by Hamad Medical Corporation at 1 site in Qatar.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Stroke, Transient Ischemic Attack (TIA)
What is being tested?
Aggressive Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteQatar
Study dates
12 Nov 2017to 30 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 16Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

YAHIA Z BASHIER IMAM, MBBS,MD,MRCP,MRCPE contact

55246887

yimam@hamad.qa

NIMA K EL KHAWAD MOHAMED AHMED, MBBS contact

33141880

drnima88@gmail.com

Qatar1 site, 1 recruiting
  • Hamad Medical Corporation

    Doha, 3050

    YAHIA Z BASHIER IMAM, MD,MRCP,MRCPE, 55246887, yimam@hamad.qa

    NIMA K EL KHAWAD MOHAMED AHMED, MBBS, 33141880, drnima88@gmail.com

    Recruiting

Other trials in Qatar

About this study

Official title: PROspective Study to OPTimize thE HEALTH of Patients With TIAS (Transient Ischemic Attack) and Stroke Admitted to the Hamad General Hospital

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.

Being tested
Aggressive Management
Keywords
cerebrovascular disease, patient management, stroke management, prognosis, 3D Carotid Doppler Imaging, Randomization
Medical subject headings
Stroke, Ischemic Attack, Transient, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aggressive ManagementOther

    With the aid of the nurse and pharmacist, the individuals in the interventional group will receive additional management of stroke by change is diet plan, increased exercise

Study groups in NCT02868723
Study groupRoleWhat they receive
Control; standard of careNo interventionAll the subjects enrolled in this arm will receive counseling as the usual standard of care by the stroke neurologists. These will include procedures and guidelines as approved by American Heart Association (AHA), follow up and guidance as offered by Hamad General Hospital's policies.
Intervention; Lifestyle counselling: BehaviouralActive comparatorSubjects in this group will receive a more detailed guidance on rigorous management of stroke and will be provided assistance from a stroke trained nurse and pharmacist additional to the counseling offered by the Stroke Neurologist.
Receives: Other: Aggressive Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression/regression of 3D plaque volume

    3D carotid doppler imaging studies

    Measured: one year

Secondary outcomes (2)
  1. Measurement of blood pressure

    management of life style

    Measured: one year

  2. Measurement of Lipid levels

    management of lifestyle

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2016 (estimated)
  2. Study start12 Nov 2017
  3. Primary completion30 Nov 2019 (estimated)
  4. Study completion30 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02868723
Sponsor's protocol ID
MRC-IRGC-02-NI-059
Acronym
PROMOTE-HEALTH
Status last verified
Aug 2018
First submitted
30 Jun 2016
Last updated
6 Sep 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32664066

Questions about this trial

What is this clinical trial studying?

A study testing Aggressive Management in people with Stroke and Transient Ischemic Attack (TIA), run by Hamad Medical Corporation at 1 site in Qatar.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact YAHIA Z BASHIER IMAM, MBBS,MD,MRCP,MRCPE (55246887, yimam@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression/regression of 3D plaque volume (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02868723, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.

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