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Evaluation of Patients With Heart Disease Not Eligible for Research Protocols

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00001458
Enrollment
7829
Registered
1999-11-04
Start date
1995-01-01
Completion date
2020-07-28
Last updated
2021-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

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

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.

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.

Interventions

None listed

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
Lead SponsorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 99 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
training of staff20 yearsstaff becomes familiar or proficient in cardiovascular diagnostic studies.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026