Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069693
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2003-09-29
Brief Title:
Evaluation of Chronic Orthostatic Intolerance
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Clinical Laboratory Evaluation of Chronic Orthostatic Intolerance
Status:
COMPLETED
Status Verified Date:
2008-08-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will conduct tests with patients with primary chronic orthostatic intolerance COI to learn more about this disorder of the autonomic nervous system
Healthy normal volunteers and patients 18 years of age and older with COI may be eligible for this study Participants undergo one or more of the following tests and procedures
Blood studies including arterial catheter insertion to measure blood pressure and collect arterial blood samples blood flow studies using sensors applied to the skin and a pressure cuff around a limb blood volume studies using injection of radioactively labeled human serum albumin and gene studies to look for genetic abnormalities associated with certain proteins
Imaging studies including CT scan of the adrenal glands heart ultrasound and PET scanning
Electrocardiogram
Microdialysis to measures levels of chemicals in the body fluid of certain tissues A thin tube is inserted into the skin and a solution is passed through it Chemicals in the body tissues enter the solution in the tube The solution is collected and the chemical levels are measured
Neck suction Neck suction is applied to test a reflex the brain uses to regulate blood pressure
Perometry Limb volume is measured using an infrared light that moves up the limb
Quantitative sudomotor axon reflex test to evaluate an aspect of autonomic nervous system function A small amount of a brain chemical acetylcholine is applied to the skin with a tiny amount of electricity and the sweat in a nearby patch of skin is measured
Skin electrical conduction test using sensors on the skin to measure sweat production
Skin and core temperature measurements using sensors on the skin and in the ear canal
Tilt table test The subject lies on a table secured with straps around the chest and legs Sensors are placed on the arms and chest to monitor blood pressure pulse rate and heart rhythm A catheter is placed in a vein in each arm to collect blood samples and give drugs Another catheter is placed in an artery to draw blood and monitor blood pressure The subject is given an infusion of norepinephrine and epinephrine and baseline measures and blood samples are taken The table is tilted upright and more measurements and blood samples are taken at intervals for up to 30 minutes The table is returned to a horizontal position and additional measurements and samples may be taken
Drugs may be administered during the tests including acetylcholine epinephrine and norepinephrine radioactive chemicals used in imaging studies and drugs that affect blood vessels heart rate and force of heart contractions
Healthy normal volunteers and patients 18 years of age and older with COI may be eligible for this study Participants undergo one or more of the following tests and procedures
Blood studies including arterial catheter insertion to measure blood pressure and collect arterial blood samples blood flow studies using sensors applied to the skin and a pressure cuff around a limb blood volume studies using injection of radioactively labeled human serum albumin and gene studies to look for genetic abnormalities associated with certain proteins
Imaging studies including CT scan of the adrenal glands heart ultrasound and PET scanning
Electrocardiogram
Microdialysis to measures levels of chemicals in the body fluid of certain tissues A thin tube is inserted into the skin and a solution is passed through it Chemicals in the body tissues enter the solution in the tube The solution is collected and the chemical levels are measured
Neck suction Neck suction is applied to test a reflex the brain uses to regulate blood pressure
Perometry Limb volume is measured using an infrared light that moves up the limb
Quantitative sudomotor axon reflex test to evaluate an aspect of autonomic nervous system function A small amount of a brain chemical acetylcholine is applied to the skin with a tiny amount of electricity and the sweat in a nearby patch of skin is measured
Skin electrical conduction test using sensors on the skin to measure sweat production
Skin and core temperature measurements using sensors on the skin and in the ear canal
Tilt table test The subject lies on a table secured with straps around the chest and legs Sensors are placed on the arms and chest to monitor blood pressure pulse rate and heart rhythm A catheter is placed in a vein in each arm to collect blood samples and give drugs Another catheter is placed in an artery to draw blood and monitor blood pressure The subject is given an infusion of norepinephrine and epinephrine and baseline measures and blood samples are taken The table is tilted upright and more measurements and blood samples are taken at intervals for up to 30 minutes The table is returned to a horizontal position and additional measurements and samples may be taken
Drugs may be administered during the tests including acetylcholine epinephrine and norepinephrine radioactive chemicals used in imaging studies and drugs that affect blood vessels heart rate and force of heart contractions
Detailed Description:
This protocol is to identify and characterize distinct types of chronic orthostatic intolerance COI COI can be a manifestation of primary chronic autonomic failure which is covered under a separate protocol The present protocol concerns patients with COI who under resting conditions have intact sympathetic neurocirculatory function COI can reflect different pathophysiologic mechanisms until now few studies have attempted to distinguish these mechanisms in individual patients We hypothesize that results of clinical assessment and physiologic chemical pharmacologic and imaging tests will reveal internally consistent patterns that distinguish particular forms of COI We wish to determine the relative frequencies of these forms in a referral population The first phase of testing is to identify sympathetic neurocirculatory failure baroreflex failure and secondary causes of COI hypovolemia excessive orthostatic venous pooling or excessive orthostatic extravasation In a subsequent inpatient phase tilt table testing is done with concurrent hemodynamic and chemical measurements to confirm subtypes of postural tachycardia syndrome and neurocardiogenic syncope The results of these evaluations will be used for stratification of specific pathophysiologically defined diagnostic groups for therapeutic protocols In an off-site study we will evaluate members of a large family where COI seems to be transmitted as an autosomal dominant trait
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-N-0314 | None | None | None |