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PET Scan in Patients With Neurocardiologic Disorders

Primary Purpose

Autonomic Nervous System Diseases

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Autonomic Nervous System Diseases focused on measuring Sympathetic Nervous System, Dysautonomias, Postural Tachycardia Syndrome, Neurocardiogenic Syncope, Hypernoradrenergic Hypertension, Sympathectomy, Fluorodopamine, Positron Emission Tomography, Norepinephrine, Dopamine, Neurocardiologic Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA: The subjects are adult patients in one of the following diagnostic categories: coronary heart disease or chest pain and normal coronary arteries; myocardial dysfunction or failure; hypertension; or dysautonomia. Groups of appropriately matched healthy volunteers are studied concurrently as controls. EXCLUSION CRITERIA: Minors are excluded. Subjects in whom anatomic factors complicate vascular access are excluded. Subjects who are not expected clinically to tolerate recumbency during the procedures are excluded. Pregnant or lactating women are excluded. Cardiology patients may be tested while off their usual medications. In this situation, the patients will be inpatients on the cardiology ward, managed clinically by staff of the Cardiology Branch, DIR, NHLBI. Hypertensives will be tested afer having discontinued anti-hypertensive medications for up to two weeks. Patients who must take medications continually in the following categories are excluded: anticoagulants, tricyclic antidepressants, barbiturates, aspirin, acetaminophen. Patients unable to discontinue nicotine or alcohol temporarily are excluded.

Sites / Locations

  • National Institute of Neurological Disorders and Stroke (NINDS)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00001418
Brief Title
PET Scan in Patients With Neurocardiologic Disorders
Official Title
Positron Emission Tomographic (PET) Scanning of Sympathetic Innervation and Function in Patients With Neurocardiologic Disorders
Study Type
Observational

2. Study Status

Record Verification Date
August 2004
Overall Recruitment Status
Completed
Study Start Date
July 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

Brief Summary
This study is designed to use PET scans in order to measure activity of the sympathetic nervous system. The sympathetic nervous system is the portion of the nervous system that maintains a normal supply of blood and fuel to organs during stressful situations. PET scan or Positron Emission Tomography is an advanced form of an X-ray. It is used to detect radioactive substances in the body. During this study researchers plan to inject small amounts of the radioactive drug fluorodopamine into patients. Fluorodopamine is very similar to the chemicals found in the sympathetic nervous system. It can attach to sympathetic nerve endings and allow researchers to view them with the aid of a PET scan. One area of the body with many sympathetic nerve endings is the heart. After giving a dose of fluorodopamine, researchers will be able to visualize all of the sympathetic nerve endings involved in the activity of the heart. In addition, this diagnostic test will help researchers detect abnormalities of the nervous system of patient's hearts.
Detailed Description
This project applies positron emission tomographic (PET) scanning after administration of 6-[18F]fluorodopamine ([18F]-6F-DA) to visualize sympathetic innervation and function in patients with neurocardiologic disorders. Patients undergo infusion of [18F]-6F-DA, followed by PET scanning of one or more body regions. Patients may also undergo PET scanning after administration of [13N]-ammonia, to assess regional perfusion; regional blood sampling (including sampling from the coronary sinus or great cardiac vein) during infusion of [3H]-l-norepinephrine ([3H]-NE), to assess the kinetics and metabolism of NE; or magnetic resonance imaging (MRI) to delineate the ventricular myocardium. PET scanning after [18F]-6F-DA administration, in conjunction with other clinical assessment tools, should provide comprehensive information about regional sympathoneural innervation and function in neurocardiologic disorders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autonomic Nervous System Diseases
Keywords
Sympathetic Nervous System, Dysautonomias, Postural Tachycardia Syndrome, Neurocardiogenic Syncope, Hypernoradrenergic Hypertension, Sympathectomy, Fluorodopamine, Positron Emission Tomography, Norepinephrine, Dopamine, Neurocardiologic Disorder

7. Study Design

Enrollment
335 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: The subjects are adult patients in one of the following diagnostic categories: coronary heart disease or chest pain and normal coronary arteries; myocardial dysfunction or failure; hypertension; or dysautonomia. Groups of appropriately matched healthy volunteers are studied concurrently as controls. EXCLUSION CRITERIA: Minors are excluded. Subjects in whom anatomic factors complicate vascular access are excluded. Subjects who are not expected clinically to tolerate recumbency during the procedures are excluded. Pregnant or lactating women are excluded. Cardiology patients may be tested while off their usual medications. In this situation, the patients will be inpatients on the cardiology ward, managed clinically by staff of the Cardiology Branch, DIR, NHLBI. Hypertensives will be tested afer having discontinued anti-hypertensive medications for up to two weeks. Patients who must take medications continually in the following categories are excluded: anticoagulants, tricyclic antidepressants, barbiturates, aspirin, acetaminophen. Patients unable to discontinue nicotine or alcohol temporarily are excluded.
Facility Information:
Facility Name
National Institute of Neurological Disorders and Stroke (NINDS)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

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PET Scan in Patients With Neurocardiologic Disorders

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