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Cardiac Rehabilitation for TIA Patients (CR-TIA)

L

Lawson Health Research Institute

Status and phase

Completed
Phase 3

Conditions

TIA (Transient Ischemic Attack)

Treatments

Behavioral: Comprehensive Cardiac Rehabilitation (CR)

Study type

Interventional

Funder types

Other

Identifiers

NCT00536562
R-07-251

Details and patient eligibility

About

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.

Full 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.

Enrollment

132 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

132 participants in 2 patient groups

Usual Care
No Intervention group
Description:
Usual Care as provided through the Stroke Prevention Clinic
Cardiac Rehabilitation
Active Comparator group
Description:
Usual Care plus Comprehensive Cardiac Rehabilitation Program
Treatment:
Behavioral: Comprehensive Cardiac Rehabilitation (CR)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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