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Evaluation of Patients With Heart Disease Not Eligible for Research Protocols

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00001458
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : March 12, 2021
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

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
Cardiovascular 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.

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Study Type : Observational
Actual Enrollment : 7829 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnosis and Treatment of Patients With Heart and Vascular Disease (Training Protocol)
Actual Study Start Date : January 1, 1995
Actual Primary Completion Date : July 28, 2020
Actual Study Completion Date : July 28, 2020

subjects with cardiovascular symptoms or known disease.

Primary Outcome Measures :
  1. training of staff [ Time Frame: 20 years ]
    staff becomes familiar or proficient in cardiovascular diagnostic studies.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects can be self-referred; referred per PCP or other specialist from any community or area of the world.@@@

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


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.

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 identifier (NCT number): NCT00001458

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Alessandra Brofferio, M.D. National Heart, Lung, and Blood Institute (NHLBI)
Additional Information:
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Responsible Party: National Heart, Lung, and Blood Institute (NHLBI) Identifier: NCT00001458    
Other Study ID Numbers: 950047
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Cardiovascular Treatment
Cardiovascular Disease
Cardiovascular Testing
Heart Disease
Muscle Leg Pain
Leg Pain
Peripheral Arterial Disease
Intermittent Claudication
Renal Vascular Disease
Uncontrolled Hypertension
Additional relevant MeSH terms:
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Cardiovascular Diseases