Completed

PET Scanning of Sympathetic Innervation in Neurocardiologic Disorders

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Study Aim

This study aims to observe the sympathetic nervous system function in individuals with neurocardiologic disorders using PET scanning.

What is being collected

Data Collection

Who is being recruted

Consciousness Disorders+10

+ Nervous System Diseases

+ Neurologic Manifestations

See all eligibility criteria
How is the trial designed

Observational
Study Start: July 1994
See protocol details

Summary

Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 1994

Actual date on which the first participant was enrolled.

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.

NCT00001418
Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

335 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Consciousness DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSyncopeUnconsciousnessNeurobehavioral ManifestationsPrimary DysautonomiasOrthostatic IntoleranceAutonomic Nervous System DiseasesSyncope, VasovagalPostural Orthostatic Tachycardia Syndrome

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, United StatesOpen National Institute of Neurological Disorders and Stroke (NINDS) in Google Maps
CompletedOne Study Center