View Clinical Trial (Medical Research Study)
Arterial Stiffness With Age: Part 1 and 2
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02114 |
| Conditions: |
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Cardiovascular Disease - Aging |
| Purpose: |
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The purpose of this study is to investigate the effects of age, exercise and cardiovascular
disease on blood pressure.
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| Study Summary: |
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This study is being done to find out how age, activity level, and the presence of heart
disease affect the way the body controls blood pressure. A total of 80 individuals will be
recruited for the study, and will consist of two groups: sedentary healthy individuals and
those with coronary artery disease (CAD). Each group will undergo screening tests, including
history, questionnaires, physical exam, lab tests, treadmill exercise tolerance test, and
maximal exercise test. These screening tests will be repeated at 3 months and 6 months.
The study involves 20 visits over a 6-month period. An exercise-training program will be
designed for the individual's fitness level. During the first month, the individual will be
supervised while exercising at Spaulding Rehabilitation Hospital, but after that may choose
to exercise at home or in a fitness center. These exercise sessions will take place 3-5
times per week for 15-40 minutes per session based on the individual's exercise program,
increasing to 4-6 times per week for 30-60 minutes per session after the first month.
Participants will be required to visit Spaulding Rehabilitation Hospital a minimum of once
every two weeks so that information can be collected from a heart rate monitor.
Testing is done at the beginning and end of the exercise-training intervention period to
determine what effect the intervention has had on the individual's blood pressure
regulation. This testing consists of 2 sequential study days. During the first day's
testing, which will last about 2 hours, the participant will receive 8 low doses of atropine
to alter vagal effects. On the second day, which will take about 4 hours, the participant
will receive sodium nitroprusside, phenylephrine, and low-dose atropine while sympathetic
nervous activity is recorded. Differences in blood pressure regulation pre- and
post-training will be studied.
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| Criteria: |
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Inclusion Criteria:
Sedentary Older Individuals Group:
- Healthy men and women ages 55-75
- Normally physically active (performing regular aerobic exercise less than 60 minutes
per week) with aerobic capacities below the 80th percentile for age and gender
Coronary Artery Disease (CAD) Group:
- Men and women ages 55-75
- Written authorization from participant's cardiologist to participate in the study
(Note: if Dr. Zervos is the participant's cardiologist, their primary care physician
will also be asked to give written authorization)
- Documented CAD by previous MI or angiography
Exclusion Criteria:
General exclusion criteria for all groups:
- Neurological diseases
- Diabetes
- History of migraine headaches
- Hypertension
- Glaucoma
- Pacemaker
- History of stroke or TIA
- High cholesterol
- Current cancer
- Benign prostatic hyperplasia
- Allergy to sulfa
- Carotid disease
- Currently taking anti-depression, anti-psychotic, or anti-anxiety medications
Sedentary Older Individuals Group:
- Coronary artery or carotid vascular disease
Coronary Artery Disease (CAD) Group:
- Myocardial Infarction (MI), Percutaneous Transluminal Coronary Angioplasty (PTCA) or
Coronary Artery Bypass Graft (CABG) in the last 3 months
- Unstable angina, EF branch block severe valvular disease, chronic atrial
fibrillation, and frequent atrial or ventricular arrhythmias (including more than 3
PVCs or APCs per minute)
- Currently taking anticoagulants or any cardioactive medications other than ACE
inhibitors, calcium channel blockers, and beta-blockers
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| NCT ID: |
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NCT00319397 |
| Primary Contact: |
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Principal Investigator
J. Andrew Taylor, PhD
Spaulding Rehabilitation Hospital, Harvard Medical School
Glen Picard, MA
Phone: 617-573-2786
Email: apicard@partners.org
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| Backup Contact: |
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Email: jandrew_taylor@hms.harvard.edu
J. Andrew Taylor, PhD
Phone: 617-573-2784
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| Location Contact: |
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Boston, Massachusetts 02114
United States
Glen Picard, MA
Phone: 617-573-2786
Email: gpicard@partners.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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