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.
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.
Qatar1 site, 1 recruiting
- 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
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.
- Conditions
- Stroke, Transient Ischemic Attack (TIA)
- 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 group | Role | What they receive |
|---|---|---|
| Control; standard of care | No intervention | All 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: Behavioural | Active comparator | Subjects 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.
Progression/regression of 3D plaque volume
3D carotid doppler imaging studies
Measured: one year
Secondary outcomes (2)
Measurement of blood pressure
management of life style
Measured: one year
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.
- First posted16 Aug 2016 (estimated)
- Study start12 Nov 2017
- Primary completion30 Nov 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- YAHIA Z BASHIER IMAM, MBBS,MRCP,MRCPE, Principal investigator, Hamad Medical Corporation
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROspective Study to OPTimize thE HEALTH of Patients With TIAS (Transient Ischemic Attack) and Stroke Admitted to the Hamad General Hospital
- ClinicalTrials.gov ID
- NCT02868723
- Acronym / sponsor ID
- PROMOTE-HEALTH / MRC-IRGC-02-NI-059
- Conditions
- Stroke, Transient Ischemic Attack (TIA)
- Keywords
- cerebrovascular disease, patient management, stroke management, prognosis, 3D Carotid Doppler Imaging, Randomization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2017 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control; standard of care | No intervention | –All 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: Behavioural | Active comparator | Other: Aggressive ManagementSubjects 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- 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
Key exclusion criteria (16 listed)
- 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:
- CT or MRI shows evidence of primary intracranial hemorrhage or neoplasm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aggressive ManagementWith 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 | Other | Intervention; Lifestyle counselling: Behavioural |
Primary outcome
Progression/regression of 3D plaque volume
Time frame: one year
3D carotid doppler imaging studies
2 secondary outcomes
Measurement of blood pressure
Time frame: one year
Measurement of Lipid levels
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Derived from this study: PubMed 32664066Imam 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YAHIA Z BASHIER IMAM, MBBS,MRCP,MRCPE principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
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.