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Cardiac Rehabilitation for TIA Patients (CR-TIA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00536562
First received: September 27, 2007
Last updated: December 13, 2010
Last verified: December 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
TIA (Transient Ischemic Attack)
 Behavioral: Comprehensive Cardiac Rehabilitation (CR)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comprehensive Cardiac Rehabilitation Programming For Patients Following Transient Ischemic Attack

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • 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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Outcomes include cerebrovascular and cardiovascular events, pre-post changes in physiological, anthropometric and behavioral vascular risk factors, neurocognitive measures, and quality of life. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: September 2007
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 0
Usual Care as provided through the Stroke Prevention Clinic
Active Comparator: 1
Usual Care plus Comprehensive Cardiac Rehabilitation Program
 Behavioral: Comprehensive Cardiac Rehabilitation (CR)
6-month Comprehensive Cardiac Rehabilitation program consisting of: 1) initial medical assessment by case manager and physician to determine CR strategies; 2) entry exercise stress test; 3) multi-disciplinary assessment and intervention to achieve risk factor targets in nutrition & psychological services as needed; 4) twice per week supervised exercise training and twice per week home-based exercise following an individualized, progressive prescription; 5) Exit assessment at 6 months.

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00536562

Contacts
Contact: Rosanna Turner, B.A. 519-685-8500 ext 36570 rosanna.turner@lhsc.on.ca
Contact: Neville Suskin, MBChB MSc 519-663-3488 neville.suskin@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Rosanna Turner, BA     519-685-8500 ext 36570     rosanna.turner@lhsc.on.ca    
Principal Investigator: Neville G. Suskin, MBChB, MSc            
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Tania Bennett, BSc     613-798-5555 ext 19275     tbennett@ottawaheart.ca    
Contact: Robert Reid, PhD, MBA     613-761-5058     breid@ottawaheart.ca    
Sub-Investigator: Robert Reid, PhD, MBA            
Sponsors and Collaborators
Lawson Health Research Institute
Heart and Stroke Foundation of Ontario
Investigators
Principal Investigator: Neville G. Suskin, MBChB, MSc University of Western Ontario & London Health Sciences Centre
  More Information

No publications provided

Responsible Party: Dr. Neville Suskin, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00536562     History of Changes
Other Study ID Numbers: R-07-251
Study First Received: September 27, 2007
Last Updated: December 13, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Comprehensive Cardiac Rehabilitation
Randomized Controlled Trial
TIA (Transient Ischemic Attack)
Mild Non-Disabling Stroke
Vascular Protection

Additional relevant MeSH terms:
Ischemic Attack, Transient
Ischemia
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013