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

September 5, 2018 updated by: Hamad Medical Corporation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: YAHIA Z BASHIER IMAM, MBBS,MD,MRCP,MRCPE
  • Phone Number: 55246887
  • Email: yimam@hamad.qa

Study Contact Backup

  • Name: NIMA K EL KHAWAD MOHAMED AHMED, MBBS
  • Phone Number: 33141880
  • Email: drnima88@gmail.com

Study Locations

  • Qatar
      • Doha, Qatar, 3050
        • Recruiting
        • Hamad Medical Corporation
        • Contact:
        • Contact:
          • YAHIA Z BASHIER IMAM, MD,MRCP,MRCPE
          • Phone Number: 55246887
          • Email: yimam@hamad.qa
        • Sub-Investigator:
          • NUMAN AMIR, MB,BS
        • Sub-Investigator:
          • MAHER SAQQUR, FRCPC
        • Sub-Investigator:
          • AHMAD MUHAMMAD, MBBS
        • Sub-Investigator:
          • DIRK DELEU, PHD
        • Sub-Investigator:
          • AHMED OWN, MD
        • Sub-Investigator:
          • AHMED EL SOTOUHY, MD
        • Sub-Investigator:
          • ABDULSALIM KILIYANNI, MD
        • Sub-Investigator:
          • ABDUL SALAM, PHD
        • Sub-Investigator:
          • MOHAMED S ABDELMONEIM, MSC
        • Sub-Investigator:
          • PAULA BOURKE, PGC
        • Sub-Investigator:
          • DEBORAH MARGARET, BSC
        • Sub-Investigator:
          • MARK SANTOS, MAN
        • Sub-Investigator:
          • SUJATHA JOSEPH, MSC
        • Sub-Investigator:
          • pablo garcia, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control; standard of care
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.
Active Comparator: Intervention; Lifestyle counselling: Behavioural
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.
Other: Aggressive Management
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression/regression of 3D plaque volume
Time Frame: one year
3D carotid doppler imaging studies
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of blood pressure
Time Frame: one year
management of life style
one year
Measurement of Lipid levels
Time Frame: one year
management of lifestyle
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamad Medical Corporation

Investigators

  • Principal Investigator: YAHIA Z BASHIER IMAM, MBBS,MRCP,MRCPE, Hamad Medical Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2017

Primary Completion (Anticipated)

November 30, 2019

Study Completion (Anticipated)

December 30, 2019

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

August 14, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRC-IRGC-02-NI-059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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