- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01758692
Measurement of Autonomic Cardiovascular Integrity in Persons With SCI
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Matthew T Maher, MS
- Phone Number: 1706 7185849000
- Email: matthew.maher@va.gov
Study Contact Backup
- Name: Jill M Wecht, Ed.D
- Phone Number: 3122 7185849000
- Email: jm.wecht@va.gov
Study Locations
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New York
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Bronx, New York, United States, 10468
- James J Peters VA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
For All Groups:
- Age 18-65 years (18-89 years for Non-Invasive Only SCI Subjects)
- Stable health for > 6 months
Non-smoker
o Subjects with SCI:
- Level of injury - C1-S4
- Duration of injury - ≥ 1 year
- AIS classification - A, B, C
Exclusion Criteria:
For Main Study SCI Group:
- Tachycardia (resting HR ≥ 100 bpm)
- Bradycardia (resting HR ≤ 40 bpm)
- Hypertension
- KNOWN:
Coronary artery disease, Chronic heart failure, Cardiac arrhythmias, Diabetes mellitus, Thyroid disease, Renal insufficiency, Hepatic disease, Autonomic neuropathy, Ulcerative colitis, Benign prostatic hyperplasia, Hiatal hernia, Glaucoma, Parkinson's disease, Stroke, other neuromuscular diseases, Known sulfite allergy or hypersensitivity, Asthma, Active illness or infection, For Non-invasives Only SCI Group
- Diabetes mellitus
- Autonomic neuropathy
- Parkinson's disease
- Active illness or infection
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Able-bodied Controls
10 controls between the ages of 18 and 65 of either gender; free of cardiovascular disease and/or medication. An addition 40 controls ages 18-89 of either gender, will perform the non-invasive manipulations only. |
Spinal Cord Injury
40 subjects to perform the pharmacological and non-invasive manipulations; between the ages of 18 and 65 years old in stable health for the last 6 months, non-smoker, and level of injury from C1 - S4 for over 1 year and an AIS classification of A, B, C. Free of arrhythmia, hypertension, cardiovascular disease, kidney disease, diabetes, neuropathies, neuromuscular disease, and sulfite allergies or hypersensitivity. 60 subjects to perform the non-invasive manipulations only; between 18-89 years of age in stable condition (>6 months), non-smoker. Level of injury from C1-S4 for over a year with a AIS classification of A, B, or C. No history of diabetes, autonomic neuropathy, parkinson's disease, or acute illness or infection. An additional 30 will perform the non-invasive testing before and after completion of an ambulatory training protocol. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Autonomic Classification
Time Frame: January 2015
|
To characterize the individual level and completeness of autonomic impairment using simultaneous pharmacological and physical provocation in persons with SCI with varying AIS classifications of motor/sensory impairment.
From these studies we anticipate a more precise diagnosis of the degree of autonomic cardiovascular impairment in individuals with SCI.
Data from the pharmacologic and physical interventions will be used to determine the validity of currently available clinical tools used in other populations of autonomic failure to diagnose the degree of cardiovascular autonomic impairment for use in the SCI population.
|
January 2015
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Edrophonium chloride as a test of cardio-vagal receptor integrity at the sinoatrial (SA) node
Time Frame: January 2015
|
The heart rate (HR) response to exogenous cholinergic stimulation with edrophonium will be compared at rest and during the CFT between the non-SCI and SCI.
We expect the resting HR response to edrophonium will be comparable in individuals with SCI and non-SCI controls, suggesting integral SA-node receptor responsiveness to acetylcholine (vagal) stimulation.
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January 2015
|
Glycopyrrolate as a test of cardio-vagal efferent integrity
Time Frame: January 2015
|
The HR response to the CFT (bradycardia) will be compared with and without glycopyrrolate in the SCI and non-SCI subjects.
We expect the HR response to the CFT (endogenous stimulation of cardio-vagal efferent activation), which induces bradycardia, will be blunted following glycopyrrolate administration in the non-SCI control subjects, but the HR response to the CFT will be unaffected by glycopyrrolate in the SCI subjects.
|
January 2015
|
Esmolol hydrochloride as a test of cardiac-specific (β1) sympathetic receptor integrity
Time Frame: January 2015
|
To compare the HR response to β1 receptor blockade in the resting and head-up tilt (HUT) states between individuals with SCI and non-SCI controls.
We expect the resting HR will be lower and the HR response to HUT will be blunted following administration of Esmolol in the non-SCI controls; these HR responses will be attenuated in persons with SCI, and the degree of blunting will be categorically delineated by level of lesion (i.e., above T1, T2-T6, T7 and below).
|
January 2015
|
Cold Face Test
Time Frame: January 2015
|
For the CFT, the data will be analyzed using a three-factor mixed ANOVA.
The dependent variable will be 20 second average heart rate.
The ANOVA will incorporate two between-subjects factors: 1) groups (levels = control, low paraplegia, high paraplegia, and tetraplegia), and 2) drug (levels = placebo, edrophonium, glycopyrrolate, glycopyrrolate & esmolol).
The within subjects factor is time (levels = pre-CFT and post-CFT).
From our previous pilot studies examining differences in HR response to CFT between control subjects and subjects grouped by SCI level, we found mean differences between groups > 11 beats per minute with a pooled standard deviation of ~ 8.5 beats per minute.
Using these estimates, with 10 subjects per group we will have over 99% power to detect differences between groups at an alpha level of 0.05.
Using a 50% more conservative effect size estimate, with 10 subjects per group we will have ~ 85% power to detect differences between groups at an alpha level of 0.05.
|
January 2015
|
Head-up Tilt Test
Time Frame: January 2015
|
For the HUT, the data will be analyzed using a three-factor mixed ANOVA.
The dependent variable will be 20 second average heart rate.
The ANOVA will incorporate two between-subjects factors: 1) groups (levels = control, low paraplegia, high paraplegia, and tetraplegia), and 2) drug (levels = placebo, edrophonium, glycopyrrolate, and glycopyrrolate + esmolol).
The within subjects factor is time (levels = pre-HUT and post-HUT).
From our previous pilot studies examining differences in HR response to HUT between control subjects and subjects grouped by SCI level, we found mean differences between groups > 3 beats per minute with a pooled standard deviation of ~ 5 beats per minute.
Using these estimates, with 10 subjects per group we will have 85% power to detect differences between groups at an alpha level of 0.05.
|
January 2015
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jill M Wecht, Ed.D., JJPVAMC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WEC-12-06
- 01436 (Other Identifier: MIRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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