Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT00001458
Status:
COMPLETED
Last Update Posted:
2021-03-12
First Post:
1999-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Patients With Heart Disease Not Eligible for Research Protocols
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D007383', 'term': 'Intermittent Claudication'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7829}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1995-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-11', 'studyFirstSubmitDate': '1999-11-03', 'studyFirstSubmitQcDate': '1999-11-03', 'lastUpdatePostDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '1999-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'training of staff', 'timeFrame': '20 years', 'description': 'staff becomes familiar or proficient in cardiovascular diagnostic studies.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiovascular Treatment', 'Cardiovascular Disease', 'Cardiovascular Testing', 'Heart Disease', 'Muscle Leg Pain', 'Leg Pain', 'Circulation', 'Peripheral Arterial Disease', 'Intermittent Claudication', 'Renal Vascular Disease', 'Uncontrolled Hypertension'], 'conditions': ['Cardiovascular Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_1995-H-0047.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'An important mission of the National Institutes of Health (NIH) is to develop and carry out research studies designed to improve understanding of disease processes and treatments.\n\nClinical research continues to become more focused on specific diseases and the signs and symptoms of diseases in specific groups of people and patients.\n\nThis study is designed to permit inpatient evaluation and care of patients with heart disease who do not qualify to participate in research studies being conducted by the Cardiology Branch of the National Heart, Lung, and Blood Institute (NHLBI). These patients are valuable to the Cardiology Branch of the NHLBI because they help to improve training and experience of its researchers.', 'detailedDescription': 'An important mission of the NIH is to the conduct of research that elucidates biological mechanisms, pathogenesis and treatment of diseases. Clinical research has evolved into an increasingly narrow focus on specific diseases and disease presentations in select subgroups of patients. It is desirable and consistent with Clinical Center policy, for clinical investigators to maintain exposure to a more broad spectrum of disease and disease presentations than mandated by the clinical research protocols in order to preserve clinical skills of physician and nursing staff, ensure adequate training of clinical research fellows, and stimulate ideas for future clinical research. This protocol permits evaluation and treatment of patients with cardiovascular diseases who do not fulfill eligibility criteria for participation in existing clinical research protocols, but who are of medical interest for the purpose of training professional staff.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects can be self-referred; referred per PCP or other specialist from any community or area of the world.@@@', 'healthyVolunteers': True, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nPatients with signs or symptoms or risk of cardiovascular disease may participate in this training protocol. The following is a representative list of the types of patient presentations and potential diagnoses eligible for this protocol:\n\nCoronary artery disease with effort or rest angina or inducible myocardial ischemia as determined by noninvasive testing.\n\nValvular heart disease.\n\nCardiomyopathies, including restrictive, congestive, and hypertrophic phenotypes.\n\nPeripheral-artery disease of upper or lower extremities, with intermittent pain with activity (e.g. claudication) or limb-threatening ischemia.\n\nRenovascular disease with uncontrolled hypertension, intermittent pulmonary edema, or evidence of ischemic nephropathy.\n\nCongenital heart disease, with communications between chambers or major vessels\n\nHeart surgery patients treated at the Clinical Center prior to closure of the Heart Surgery Branch in 1990\n\nEXCLUSION CRITERIA:\n\nPregnancy, for those patients who require testing or treatment requiring dobutamine, gadolinium or contrast media or radiation exposure.\n\nInability of patient, parent or legal guardian to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT00001458', 'briefTitle': 'Evaluation of Patients With Heart Disease Not Eligible for Research Protocols', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Diagnosis and Treatment of Patients With Heart and Vascular Disease (Training Protocol)', 'orgStudyIdInfo': {'id': '950047'}, 'secondaryIdInfos': [{'id': '95-H-0047'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiovascular', 'description': 'subjects with cardiovascular symptoms or known disease.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center, 9000 Rockville Pike', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Alessandra Brofferio, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Heart, Lung, and Blood Institute (NHLBI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}