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OpenTrials
Completed

NCT Number: NCT00001458

Evaluation of Patients With Heart Disease Not Eligible for Research Protocols

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.

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Key information

Age range

Up to 99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Primary outcomes

  1. training of staff

    Time frame: 20 years

    staff becomes familiar or proficient in cardiovascular diagnostic studies.

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Registry information

Official study title

Diagnosis and Treatment of Patients With Heart and Vascular Disease (Training Protocol)

Important dates

Study start
1995
Primary completion
2020
Study completion
2020
First posted
Nov 4, 1999
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.