Cerebrovascular Outcomes in Ischemic Heart Disease

NCT02715661 | Completed

• 1 other identifier: 107620
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

blood flow; brain health; exercise; endothelial activation

Outcome Measures

Primary Outcomes (1)

• cerebrovascular properties

  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.

  baseline and 6 months

Secondary Outcomes (4)

• 1) vascular cognitive impairment

  baseline and 6 months

• 2) Brain grey matter and white matter mass, white matter hyperintensities

  baseline and 6 months

• 3) blood borne markers of inflammation

  baseline and 6 months

• 4) vascular endothelial damage

  baseline and 6 months

Study Arms (3)

Coronary artery disease

ACTIVE COMPARATOR

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

Metabolic Syndrome

ACTIVE COMPARATOR

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

Health Control

ACTIVE COMPARATOR

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

Interventions

exercise OTHER

six-month interval of exercise

Coronary artery disease; Health Control; Metabolic Syndrome

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Coronary Artery Disease
• 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:
• 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
• both female and male participants are being studied

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator

Study Sites (1)

the University of Western Ontario

London, Ontario, N6A 5B9, Canada

Location

Related Publications (11)

• Anazodo UC, Shoemaker JK, Suskin N, St Lawrence KS. An investigation of changes in regional gray matter volume in cardiovascular disease patients, pre and post cardiovascular rehabilitation. Neuroimage Clin. 2013 Oct 6;3:388-95. doi: 10.1016/j.nicl.2013.09.011. eCollection 2013.

  PMID: 24273722 RESULT

• Barnes JN, Schmidt JE, Nicholson WT, Joyner MJ. Cyclooxygenase inhibition abolishes age-related differences in cerebral vasodilator responses to hypercapnia. J Appl Physiol (1985). 2012 Jun;112(11):1884-90. doi: 10.1152/japplphysiol.01270.2011. Epub 2012 Mar 22.

  PMID: 22442028 RESULT

• Beeri MS, Rapp M, Silverman JM, Schmeidler J, Grossman HT, Fallon JT, Purohit DP, Perl DP, Siddiqui A, Lesser G, Rosendorff C, Haroutunian V. Coronary artery disease is associated with Alzheimer disease neuropathology in APOE4 carriers. Neurology. 2006 May 9;66(9):1399-404. doi: 10.1212/01.wnl.0000210447.19748.0b.

  PMID: 16682673 RESULT

• Booth FW, Roberts CK, Laye MJ. Lack of exercise is a major cause of chronic diseases. Compr Physiol. 2012 Apr;2(2):1143-211. doi: 10.1002/cphy.c110025.

  PMID: 23798298 RESULT

• Dishman RK, Berthoud HR, Booth FW, Cotman CW, Edgerton VR, Fleshner MR, Gandevia SC, Gomez-Pinilla F, Greenwood BN, Hillman CH, Kramer AF, Levin BE, Moran TH, Russo-Neustadt AA, Salamone JD, Van Hoomissen JD, Wade CE, York DA, Zigmond MJ. Neurobiology of exercise. Obesity (Silver Spring). 2006 Mar;14(3):345-56. doi: 10.1038/oby.2006.46.

  PMID: 16648603 RESULT

• Erickson KI, Voss MW, Prakash RS, Basak C, Szabo A, Chaddock L, Kim JS, Heo S, Alves H, White SM, Wojcicki TR, Mailey E, Vieira VJ, Martin SA, Pence BD, Woods JA, McAuley E, Kramer AF. Exercise training increases size of hippocampus and improves memory. Proc Natl Acad Sci U S A. 2011 Feb 15;108(7):3017-22. doi: 10.1073/pnas.1015950108. Epub 2011 Jan 31.

  PMID: 21282661 RESULT

• Filippini N, Ebmeier KP, MacIntosh BJ, Trachtenberg AJ, Frisoni GB, Wilcock GK, Beckmann CF, Smith SM, Matthews PM, Mackay CE. Differential effects of the APOE genotype on brain function across the lifespan. Neuroimage. 2011 Jan 1;54(1):602-10. doi: 10.1016/j.neuroimage.2010.08.009. Epub 2010 Aug 10.

  PMID: 20705142 RESULT

• Heli V, Ihab H, Kun H, Brad M, Jessica W, Vera N. Effects of exercise program on physiological functions in postmenopausal women with metabolic syndrome. Int J Gerontol. 2013 Dec;7(4):231-235. doi: 10.1016/j.ijge.2013.05.002.

  PMID: 24634702 RESULT

• Pires PW, Dams Ramos CM, Matin N, Dorrance AM. The effects of hypertension on the cerebral circulation. Am J Physiol Heart Circ Physiol. 2013 Jun 15;304(12):H1598-614. doi: 10.1152/ajpheart.00490.2012. Epub 2013 Apr 12.

  PMID: 23585139 RESULT

• Yates KF, Sweat V, Yau PL, Turchiano MM, Convit A. Impact of metabolic syndrome on cognition and brain: a selected review of the literature. Arterioscler Thromb Vasc Biol. 2012 Sep;32(9):2060-7. doi: 10.1161/ATVBAHA.112.252759.

  PMID: 22895667 RESULT

• Anazodo UC, Shoemaker JK, Suskin N, Ssali T, Wang DJ, St Lawrence KS. Impaired Cerebrovascular Function in Coronary Artery Disease Patients and Recovery Following Cardiac Rehabilitation. Front Aging Neurosci. 2016 Jan 5;7:224. doi: 10.3389/fnagi.2015.00224. eCollection 2015.

  PMID: 26779011 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kevin Shoemaker, PhD

  University of Western Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Kevin Shoemaker

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 22, 2016
• Study Start: March 1, 2016
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: October 2, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)