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Cerebrovascular Outcomes in Ischemic Heart Disease (IHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715661
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : October 2, 2019
Sponsor:
Collaborator:
Lawson Health Research Institute
Information provided by (Responsible Party):
Kevin Shoemaker, Western University, Canada

Brief Summary:
This project will examine the association between (cardio)vascular disease, blood supply to the brain, and cerebrovascular endothelial activation. Also, we will investigate the impact of exercise rehabilitation on brain vascularization, cerebrovascular endothelial function and blood flow control.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Other: exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cerebrovascular Outcomes in Ischemic Heart Disease Patients Undergoing Cardiac Rehabilitation
Study Start Date : March 2016
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Coronary artery disease
those with a diagnosis of coronary artery disease having been hospitalized for a cardiac event. The intervention is six-month interval of exercise .
Other: exercise
six-month interval of exercise

Active Comparator: Metabolic Syndrome
Metabolic Syndrome patients are defined by having Systolic Blood Pressure (SBP)>130 and/or Diastolic Blood Pressure (DBP)>85 mmHg and any two of the following criteria: Abdominal obesity (waist circumference >102cm in males;>88cm in females), Fasting triglycerides > 1.695 mmol/L, Low HDL cholesterol: Males < 1.04 mmol/L; Females < 1.29 mmol/L, Fasting glucose >5.60 mmol/L. Participants will be assigned randomly into an exercise and a delayed exercise intervention, 6 months.
Other: exercise
six-month interval of exercise

Active Comparator: Health Control
Control individuals will have no diagnosis of cardiac, vascular, metabolic, inflammatory or neurological disease, and have not been on any medication for such conditions in the past 12 months. Participants will be assigned randomly into an exercise and a delayed exercise intervention, 6 months.
Other: exercise
six-month interval of exercise




Primary Outcome Measures :
  1. cerebrovascular properties [ Time Frame: baseline and 6 months ]

    This will be measured first by the change in blood flow velocity through the middle cerebral artery in response to the 5% CO2/95% O2 challenge and a sit-to-stand manoeuvre. Measures will be made using transcranial Doppler. Subsequently, the diameter of the middle cerebral artery will be measured with MRI T2 sequences (time of flight) at 7Tesla.

    Multiple measurements will be aggregated to arrive at one reported value of cerebrovascular reactivity to carbon dioxide.



Secondary Outcome Measures :
  1. 1) vascular cognitive impairment [ Time Frame: baseline and 6 months ]
    These will be made with pen-and paper questionnaires identified above.

  2. 2) Brain grey matter and white matter mass, white matter hyperintensities [ Time Frame: baseline and 6 months ]

    This is measured from the MRI T1 anatomical and FLAIR sequences.

    Multiple measurements will be aggregated to scientifically examine the association between (cardio)vascular disease, blood supply to the brain, and cerebrovascular endothelial activation. These measurements will allow us to investigate the impact of exercise rehabilitation on brain vascularization, cerebrovascular endothelial function and blood flow control.


  3. 3) blood borne markers of inflammation [ Time Frame: baseline and 6 months ]
    will be measured using multiplex and ELISA technology,

  4. 4) vascular endothelial damage [ Time Frame: baseline and 6 months ]
    will be assessed using ultrasound imaging analysis of intima-media thickness (Carotid artery) and the flow-mediated dilation of the brachial artery.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Coronary Artery Disease

  • inclusion age range is 45-80 years of age
  • both female and male participants are being studied
  • upon discharge from hospital, are referred into Cardiac Rehabilitation (CR) programs in London. Prospective able to read & write English
  • living in private residence
  • under the care of a family physician, having been discharged from hospital following admission for acute coronary syndrome (e.g. ST elevation or non ST elevation MI), angina, per cutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG) as documented by the attending physician.
  • Coronary artery disease patients who were not eligible for cardiac rehabilitation or who were referred to CR but have declined (by not enrolling or attending CR) will be invited as Usual Care (CADuc) Coronary artery disease Subjects.

Metabolic Syndrome Group:

  • inclusion age range is 45-80 years of age
  • both female and male participants are being studied
  • Systolic Blood Pressure>130 and/or Diastolic Blood Pressure>85 mmHg
  • any two of the following criteria:
  • Abdominal obesity (waist circumference >102cm in males;>88cm in females), Fasting triglycerides > 1.695 mmol/L, Low HDL cholesterol: Males < 1.04 mmol/L; Females < 1.29 mmol/L, Fasting glucose >5.60 mmol/L
  • able to read & write English
  • living in private residence

Healthy Control Group

  • the inclusion age range is 18-80 years of age
  • both female and male participants are being studied
  • Control individuals will have no diagnosis of cardiac, vascular, metabolic, inflammatory or neurological disease, and have not been on any medication for such conditions in the past 12 months able to read & write English
  • living in private residence

Exclusion Criteria:

  • As magnetic resonance imaging (MRI) is used to examine the brain in this study, participants will not be included in the study if they have any history of head or eye injury involving metal fragments, some type of implanted electrical device (such as a cardiac pacemaker). If they have severe heart disease (including susceptibility to heart rhythm abnormalities), they should not have an MRI scan unless supervised by a physician. Additionally they should not have a MRI scan if they have conductive implants or devices such as skin patches, body piercing or tattoos containing metallic inks because there is a risk of heating or induction of electrical currents within the metal element causing burns to adjacent tissue. In addition to these guidelines, patients with claustrophobia will not be studied in the MRI elements of this project.
  • respiratory disease
  • a history of psychosis
  • eating disorders
  • manic or bipolar disorder
  • major psychiatric conditions
  • immunological, congenital or neurodegenerative disorders (e.g., Raynaud's syndrome, multiple sclerosis, Parkinson's Disease, ALS),
  • dependence on alcohol or drugs within the past year
  • who smoke (within the past five years)
  • women who are pregnant or trying to become pregnant will also be excluded
  • participants will be excluded if they are unable to provide written informed consent, or to complete questionnaires or health history forms due to language or cognitive difficulties
  • coronary artery disease Subjects will be excluded if they have:
  • unstable heart rhythm
  • congenital coronary abnormality
  • cardiomyopathy
  • severe congestive heart failure
  • 2°-3° atrioventricular block
  • more than 2 M.I.s
  • major arrhythmias such as atrial fibrillation or more than 4 ectopic beats/min, sick sinus syndrome, or are scheduled to undergo PCI or CABG within 2 months following hospital discharge
  • all healthy Control and Metabolic Syndrome participants will provide clearance from their Family Physician to participate in exercise training on the Physical Activity Readiness Questionnaire (PARQ) Form.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715661


Locations
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Canada, Ontario
the University of Western Ontario
London, Ontario, Canada, N6A 5B9
Sponsors and Collaborators
Western University, Canada
Lawson Health Research Institute
Investigators
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Principal Investigator: Kevin Shoemaker, PhD University of Western Ontario, Canada
Publications of Results:

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Responsible Party: Kevin Shoemaker, Dr. Kevin Shoemaker, Western University, Canada
ClinicalTrials.gov Identifier: NCT02715661    
Other Study ID Numbers: 107620
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kevin Shoemaker, Western University, Canada:
blood flow
brain health
exercise
endothelial activation
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases