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Cardiac Rehabilitation for TIA Patients (CR-TIA)

Primary Purpose

TIA (Transient Ischemic Attack)

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Comprehensive Cardiac Rehabilitation (CR)
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TIA (Transient Ischemic Attack) focused on measuring Comprehensive Cardiac Rehabilitation, Randomized Controlled Trial, TIA (Transient Ischemic Attack), Mild Non-Disabling Stroke, Vascular Protection

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • London Health Sciences Centre
  • University of Ottawa Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Usual Care

Cardiac Rehabilitation

Arm Description

Usual Care as provided through the Stroke Prevention Clinic

Usual Care plus Comprehensive Cardiac Rehabilitation Program

Outcomes

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.

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.

Full Information

First Posted
September 27, 2007
Last Updated
August 12, 2019
Sponsor
Lawson Health Research Institute
Collaborators
Heart and Stroke Foundation of Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT00536562
Brief Title
Cardiac Rehabilitation for TIA Patients
Acronym
CR-TIA
Official Title
Comprehensive Cardiac Rehabilitation Programming For Patients Following Transient Ischemic Attack
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 15, 2014 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Heart and Stroke Foundation of Ontario

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TIA (Transient Ischemic Attack)
Keywords
Comprehensive Cardiac Rehabilitation, Randomized Controlled Trial, TIA (Transient Ischemic Attack), Mild Non-Disabling Stroke, Vascular Protection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual Care as provided through the Stroke Prevention Clinic
Arm Title
Cardiac Rehabilitation
Arm Type
Active Comparator
Arm Description
Usual Care plus Comprehensive Cardiac Rehabilitation Program
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive Cardiac Rehabilitation (CR)
Other Intervention Name(s)
Cardiac Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neville G. Suskin, MBChB, MSc
Organizational Affiliation
University of Western Ontario & London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada

12. IPD Sharing Statement

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Cardiac Rehabilitation for TIA Patients

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