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Cardiac Rehabilitation for TIA Patients (CR-TIA)

This study is currently recruiting participants.
Verified by Lawson Health Research Institute, July 2008

Sponsors and Collaborators: Lawson Health Research Institute
Heart and Stroke Foundation of Ontario
Information provided by: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00536562
  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 III

MedlinePlus related topics:   Depression    Exercise and Physical Fitness    Rehabilitation    Transient Ischemic Attack   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:   Comprehensive Cardiac Rehabilitation Programming For Patients Following Transient Ischemic Attack

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 2010
Estimated Primary Completion Date:   March 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
0: No Intervention
Usual Care as provided through the Stroke Prevention Clinic
1: Active Comparator
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 32343     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 32343     rosanna.turner@lhsc.on.ca    
      Principal Investigator: Neville G. Suskin, MBChB, MSc            
University of Ottawa Heart Institute     Not yet recruiting
      Ottawa, Ontario, Canada, K1Y 4W7
      Contact: Gareth R. Davies, BSc, BScH     613-798-5555 ext 17195     gdavies@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


Responsible Party:   Lawson Health Research Institute ( Dr. Neville Suskin )
Study ID Numbers:   R-07-251
First Received:   September 27, 2007
Last Updated:   July 25, 2008
ClinicalTrials.gov Identifier:   NCT00536562
Health Authority:   Canada: Health Canada

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

Study placed in the following topic categories:
Ischemic Attack, Transient
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Brain Ischemia
Ischemia
Brain Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:
Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 24, 2008




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