Evaluation of Patients With Heart Disease Not Eligible for Research Protocols

Sponsor

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00001458

Collaborator

(none)

7,829

Enrollment

Location

306.9

Actual Duration (Months)

25.5

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

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 :

Jan 1, 1995

Actual Primary Completion Date :

Jul 28, 2020

Actual Study Completion Date :

Jul 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Cardiovascular subjects with cardiovascular symptoms or known disease.

Outcome Measures

Primary Outcome Measures

training of staff [20 years]
staff becomes familiar or proficient in cardiovascular diagnostic studies.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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