Autonomic Nervous System DiseasesNCT00001418
PET Scan in Patients With Neurocardiologic Disorders
An observational study of Autonomic Nervous System Diseases, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Autonomic Nervous System Diseases
- How many people
- 335 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1994to Aug 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Positron Emission Tomographic (PET) Scanning of Sympathetic Innervation and Function in Patients With Neurocardiologic Disorders
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.
Read the 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.
- Conditions
- 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
- Medical subject headings
- Autonomic Nervous System Diseases, Postural Orthostatic Tachycardia Syndrome, Syncope, Vasovagal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startJul 1994
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic Nervous System DiseasesStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 335 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001418
- Sponsor's protocol ID
- 940186
- Other IDs
- 94-N-0186
- Status last verified
- Aug 2004
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomographic (PET) Scanning of Sympathetic Innervation and Function in Patients With Neurocardiologic Disorders
- ClinicalTrials.gov ID
- NCT00001418
- Acronym / sponsor ID
- 940186
- Conditions
- Autonomic Nervous System Diseases
- Keywords
- Sympathetic Nervous System, Dysautonomias, Postural Tachycardia Syndrome, Neurocardiogenic Syncope, Hypernoradrenergic Hypertension, Sympathectomy, Fluorodopamine, Positron Emission Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 335 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jul 1994
- Study completion
- Aug 2004
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autonomic Nervous System Diseases, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.