Clinical trial NCT00536562: Cardiac Rehabilitation for TIA Patients
Official title: Comprehensive Cardiac Rehabilitation Programming For Patients Following Transient Ischemic Attack
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: TIA (Transient Ischemic Attack)
Keywords: Comprehensive Cardiac Rehabilitation
Randomized Controlled Trial
TIA (Transient Ischemic Attack)
Mild Non-Disabling Stroke
Vascular Protection
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
First posted: 2007-09-28
Enrollment: 132
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine, in patients following a TIA, whether a 6-month case-managed exercise based multi-factorial cardiac rehabilitation program (CR), similar to those used in patients following a heart attack, can significantly improve exercise capacity, reduce cholesterol, reduce depression, and improve thinking ability.

Detailed description: Similar risk factors predispose patients to both cardiovascular and cerebrovascular events. Two hundred consecutive patients from Stroke Prevention Clinics (SPC) at London Health Sciences Centre and the Ottawa Hospital (100 patients from each site) who have sustained a Transient Ischemic Attack (TIA) or mild non-disabling stroke will participate in a randomized controlled trial in which they will either receive Usual Care (UC) as delivered by the SPC, or enter the existing multi-disciplinary 6-month comprehensive cardiac rehabilitation (CR) intervention at LHSC and Ottawa in addition to receiving UC. This study seeks to determine the benefits of providing a CR program to TIA/mild non-disabling stroke patients.

Eligibility criteria: Inclusion Criteria:

* Documented TIA or mild non-disabling stroke within the previous 3 months.
* At least one of the following vascular risk factors: hypertension, ischemic heart disease, diabetes mellitus, dyslipidemia or cigarette smoking

Exclusion Criteria:

* Inability to speak or understand English or provide informed consent.
* Severe aphasia that renders communication difficult or impossible.
* Modified Rankin Scale score of greater than or equal to 3.
* Mini-Mental Status Examination score of less than or equal to 20.
* Evidence of intracranial hemorrhage confirmed by CT scan or MRI study.
* Anticipated or recent (\<30 days) carotid endarterectomy, angioplasty and/or stenting.
* Resides \>1 hour travel time from London or Ottawa.
* Prior participation in a CCR program.
* Inability to perform expected exercise training of CCR program.
* Evidence of cardioembolic source for TIA/stroke such as atrial fibrillation, valvular disease, septal defect or left ventricular wall motion abnormality.
* Participation in another clinical trial that could interfere with the intervention or outcomes of the current study.

Primary outcomes:
measure: To determine compared to usual care, whether a 6-month CR strategy results in significant improvements of functional capacity, lipid profile, depression symptoms and cognition.
timeFrame: 6 months
Secondary outcomes:
measure: Outcomes include cerebrovascular and cardiovascular events, pre-post changes in physiological, anthropometric and behavioral vascular risk factors, neurocognitive measures, and quality of life.
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: University of Western Ontario & London Health Sciences Centre
name: Neville G. Suskin, MBChB, MSc
role: PRINCIPAL_INVESTIGATOR
References: