TIA (Transient Ischemic Attack)Phase 3CR-TIANCT00536562

Cardiac Rehabilitation for TIA Patients

A Phase 3 study testing Comprehensive Cardiac Rehabilitation (CR) in people with TIA (Transient Ischemic Attack), run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: TIA (Transient Ischemic Attack)
What is being tested?: Comprehensive Cardiac Rehabilitation (CR)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 132 participants
Where: 2 sitesCanada
Study dates: Sep 2007to 30 Jun 2018
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

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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 locations and contacts

2 sites in 1 country.

Canada2 sites

London Health Sciences Centre
London, Ontario, N6A 5A5
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7

Other trials in Canada

About this study

Official title: Comprehensive Cardiac Rehabilitation Programming For Patients Following Transient Ischemic Attack

Read the 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.

Conditions: TIA (Transient Ischemic Attack)
Being tested: Comprehensive Cardiac Rehabilitation (CR)
Keywords: Comprehensive Cardiac Rehabilitation, Randomized Controlled Trial, TIA (Transient Ischemic Attack), Mild Non-Disabling Stroke, Vascular Protection
Medical subject headings: Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Comprehensive Cardiac Rehabilitation (CR)Behavioural
Also called Cardiac Rehabilitation
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.

Study groups in NCT00536562
Study group	Role	What they receive
Usual Care	No intervention	Usual Care as provided through the Stroke Prevention Clinic
Cardiac Rehabilitation	Active comparator	Usual Care plus Comprehensive Cardiac Rehabilitation Program Receives: Behavioral: Comprehensive Cardiac Rehabilitation (CR)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months

Secondary outcomes (1)

Outcomes include cerebrovascular and cardiovascular events, pre-post changes in physiological, anthropometric and behavioral vascular risk factors, neurocognitive measures, and quality of life.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 200730 Jun 2018

First posted28 Sep 2007 (estimated)
Study startSep 2007
Primary completion15 Jun 2014
Study completion30 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for TIA (Transient Ischemic Attack)Studies of the same condition, open and under way.
More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 132 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00536562
Sponsor's protocol ID: R-07-251
Acronym: CR-TIA
Status last verified: Aug 2019
First submitted: 27 Sep 2007
Last updated: 13 Aug 2019
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruitingPhase 3
Upfront Lipid-Lowering Therapy With Statins Combined With Hybutimibe in Patients With Acute Ischemic Stroke or Transient Ischemic Attack.
Ischemia Stroke, TIA (Transient Ischemic Attack)
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack

All TIA (Transient Ischemic Attack) trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comprehensive Cardiac Rehabilitation Programming For Patients Following Transient Ischemic Attack
ClinicalTrials.gov ID: NCT00536562
Acronym / sponsor ID: CR-TIA / R-07-251
Conditions: TIA (Transient Ischemic Attack)
Keywords: Comprehensive Cardiac Rehabilitation, Randomized Controlled Trial, TIA (Transient Ischemic Attack), Mild Non-Disabling Stroke, Vascular Protection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 132 participants (actual)
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
Collaborators: Heart and Stroke Foundation of Ontario
Study start: Sep 2007
Primary completion: 15 Jun 2014 (actual)
Study completion: 30 Jun 2018 (actual)
First posted: 28 Sep 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Usual Care	No intervention	–Usual Care as provided through the Stroke Prevention Clinic
Cardiac Rehabilitation	Active comparator	Behavioral: Comprehensive Cardiac Rehabilitation (CR)Usual Care plus Comprehensive Cardiac Rehabilitation Program

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Comprehensive Cardiac Rehabilitation (CR)Also: Cardiac Rehabilitation6-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.	Behavioural	Cardiac Rehabilitation

Primary outcome

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

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.

Related trials for TIA (Transient Ischemic Attack)

Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruitingPhase 3
Upfront Lipid-Lowering Therapy With Statins Combined With Hybutimibe in Patients With Acute Ischemic Stroke or Transient Ischemic Attack.
Ischemia Stroke, TIA (Transient Ischemic Attack)
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Neville G. Suskin, MBChB, MSc principal investigator

University of Western Ontario & London Health Sciences Centre

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00536562.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.