Clinical trial NCT01758692: Measurement of Autonomic Cardiovascular Integrity in Persons With SCI
Official title: Measurement of Autonomic Cardiovascular Integrity in Persons With SCI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
autonomic integrity
autonomic dysreflexia
baroreceptor integrity
sympathetic integrity
vagal integrity
Lead sponsor: James J. Peters Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2013-01-01
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Forty subjects with chronic SCI and 10 age and gender matched able-bodied controls will be recruited. A subgroup of 20 subjects with SCI will be recruited solely for the non-invasive portion of the study. These patients will not undergo the pharmacological/placebo administration or any of the manipulations being performed in the ICU. An additional 30 subjects will complete the non-invasive portion before and after completion of an ambulatory training protocol. This includes subjects who have completed various protocols in the Cardioautonomic Program or patients referred by their physician following routine physical examinations. Physicians will be informed of the inclusion and exclusion criteria for this study and will be able to provide us with the assurance that the patient is an appropriate candidate for the study and that he/she was willing to speak with the study coordinators.

Brief summary: People with a spinal cord injury (SCI) have limited ability to move and feel sensation below the level of the SCI. Doctors and researchers have tests which determine the level of function and sensation, this test was developed by the American Spinal Cord Injury Association (ASIA) and has been modified over the years to improve use and sensitivity. Most recently, the ASIA Injury classification Scale (AIS) was modified in 2011, but this test does not include the evaluation of autonomic nervous system (ANS) impairment. However, people with SCI do have impairment of the ANS and this may adversely affect how organ systems in the body function. Specifically, ANS impairment tends to result in changes in heart rate and blood pressure that may relate to the level of the SCI, but this is not fully understood. In this investigation we hope to develop simple tests which will allow doctors and scientist the ability to measure the amount of ANS impairment to the cardiovascular system, specifically the heart. The first part of the study will be to determine the heart rate response to several tests (administration of drugs and physical challenges) which will change heart rate. These tests will be given to people with and without SCI and the heart rate response will be compared between people with and without SCI. The bigger the difference in the heart rate response to these test between people with and without SCI the greater degree of ANS impairment in the people with SCI. Once this heart rate difference is determined, several simple tests (deep breathing, saliva test, Valsalva) will be performed in people with and without SCI to again compare the heart rate response. The second part of this study will be to determine if the heart rate responses to the first set of tests (administration of drugs and physical challenges) can predict the heart rate response to these simple tests (deep breathing, saliva test, Valsalva). The aim of this study is to develop a simple battery of tests which can be easily used by doctors and scientists to determine the degree of ANS impairment to the heart in persons with SCI.


Eligibility criteria: 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

Primary outcomes:
measure: Autonomic Classification
timeFrame: January 2015
Secondary outcomes:
measure: Edrophonium chloride as a test of cardio-vagal receptor integrity at the sinoatrial (SA) node
timeFrame: January 2015
measure: Glycopyrrolate as a test of cardio-vagal efferent integrity
timeFrame: January 2015
measure: Esmolol hydrochloride as a test of cardiac-specific (β1) sympathetic receptor integrity
timeFrame: January 2015
measure: Cold Face Test
timeFrame: January 2015
measure: Head-up Tilt Test
timeFrame: January 2015
Other outcomes:
Locations:
city: Bronx
country: United States
facility: James J Peters VA Medical Center
state: New York
Study officials:
affiliation: JJPVAMC
name: Jill M Wecht, Ed.D.
role: PRINCIPAL_INVESTIGATOR
References: