Nctid:
NCT00001418
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-28"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D001342", "term"=>"Autonomic Nervous System Diseases"}, {"id"=>"D054969", "term"=>"Primary Dysautonomias"}], "browseLeaves"=>[{"id"=>"M16384", "name"=>"Tachycardia", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10024", "name"=>"Hypertension", "relevance"=>"LOW"}, {"id"=>"M27982", "name"=>"Postural Orthostatic Tachycardia Syndrome", "relevance"=>"LOW"}, {"id"=>"M4643", "name"=>"Autonomic Nervous System Diseases", "asFound"=>"Autonomic Nervous System Diseases", "relevance"=>"HIGH"}, {"id"=>"M27979", "name"=>"Primary Dysautonomias", "asFound"=>"Autonomic Nervous System Diseases", "relevance"=>"HIGH"}, {"id"=>"M16353", "name"=>"Syncope", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M12575", "name"=>"Norepinephrine", "relevance"=>"LOW"}, {"id"=>"M7473", "name"=>"Dopamine", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Vasoconstrictor Agents", "abbrev"=>"VaCoAg"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Cardiotonic Agents", "abbrev"=>"CaAg"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "enrollmentInfo"=>{"count"=>335}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1994-07"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2004-08", "completionDateStruct"=>{"date"=>"2004-08"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Sympathetic Nervous System", "Dysautonomias", "Postural Tachycardia Syndrome", "Neurocardiogenic Syncope", "Hypernoradrenergic Hypertension", "Sympathectomy", "Fluorodopamine", "Positron Emission Tomography", "Norepinephrine", "Dopamine", "Neurocardiologic Disorder"], "conditions"=>["Autonomic Nervous System Diseases"]}, "descriptionModule"=>{"briefSummary"=>"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.\n\nPET 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.", "detailedDescription"=>"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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>true, "eligibilityCriteria"=>"INCLUSION CRITERIA:\n\nThe 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.\n\nEXCLUSION CRITERIA:\n\nMinors are excluded.\n\nSubjects in whom anatomic factors complicate vascular access are excluded.\n\nSubjects who are not expected clinically to tolerate recumbency during the procedures are excluded.\n\nPregnant or lactating women are excluded.\n\nCardiology 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.\n\nPatients who must take medications continually in the following categories are excluded: anticoagulants, tricyclic antidepressants, barbiturates, aspirin, acetaminophen.\n\nPatients unable to discontinue nicotine or alcohol temporarily are excluded."}, "identificationModule"=>{"nctId"=>"NCT00001418", "briefTitle"=>"PET Scan in Patients With Neurocardiologic Disorders", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Positron Emission Tomographic (PET) Scanning of Sympathetic Innervation and Function in Patients With Neurocardiologic Disorders", "orgStudyIdInfo"=>{"id"=>"940186"}, "secondaryIdInfos"=>[{"id"=>"94-N-0186"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Institute of Neurological Disorders and Stroke (NINDS)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Neurological Disorders and Stroke (NINDS)", "class"=>"NIH"}}}}
