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Evaluation of Patients With Heart Disease Not Eligible for Research Protocols

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ClinicalTrials.gov Identifier: NCT00001458
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Description
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Brief Summary:

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.

Clinical research continues to become more focused on specific diseases and the signs and symptoms of diseases in specific groups of people and patients.

This 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.


Condition or disease
Heart Disease

Detailed Description:
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.

Study Design
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Study Type : Observational
Estimated Enrollment : 99999999 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnosis and Treatment of Patients With Heart and Vascular Disease (Training Protocol)
Study Start Date : January 9, 1995

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Patients 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:

Coronary artery disease with effort or rest angina or inducible myocardial ischemia as determined by noninvasive testing.

Valvular heart disease.

Cardiomyopathies, including restrictive, congestive, and hypertrophic phenotypes.

Peripheral-artery disease of upper or lower extremities, with intermittent pain with activity (e.g. claudication) or limb-threatening ischemia.

Renovascular disease with uncontrolled hypertension, intermittent pulmonary edema, or evidence of ischemic nephropathy.

Congenital heart disease, with communications between chambers or major vessels

Heart surgery patients treated at the Clinical Center prior to closure of the Heart Surgery Branch in 1990

EXCLUSION CRITERIA:

Pregnancy, for those patients who require testing or treatment requiring dobutamine, gadolinium or contrast media or radiation exposure.

Inability of patient, parent or legal guardian to provide informed consent.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001458


Contacts
Contact: Annette Stine, R.N. (301) 402-5558 stinea@nhlbi.nih.gov
Contact: Alessandra Brofferio, M.D. (301) 496-2634 brofferioa@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Alessandra Brofferio, M.D. National Heart, Lung, and Blood Institute (NHLBI)
More Information
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Additional Information:
NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00001458     History of Changes
Other Study ID Numbers: 950047
95-H-0047
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: February 23, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Heart Disease
Peripheral Arterial Disease
Intermittent Claudication
Renal Vascular Disease
Exercise Testing
Echocardiography
Cardiac Catheterization
 Radionuclide Stress Testing
Holter Monitoring
Muscle Leg Pain
Leg Pain
Circulation
Uncontrolled Hypertension

Additional relevant MeSH terms:
Heart Diseases
Vascular Diseases
Cardiovascular Diseases