Evaluation of Patients With Heart Disease Not Eligible for Research Protocols

• ClinicalTrials.gov Identifier: NCT00001458
• Recruitment Status: Completed
• First Posted: November 4, 1999
• Last Update Posted: March 12, 2021
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

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
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: January 1, 1995
• Actual Primary Completion Date: July 28, 2020
• Actual Study Completion Date: July 28, 2020

Groups and Cohorts

Group/Cohort
Cardiovascular; subjects with cardiovascular symptoms or known disease.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• 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.@@@

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

Locations

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)

Investigators

• Principal Investigator: Alessandra Brofferio, M.D.; National Heart, Lung, and Blood Institute (NHLBI)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page 

• Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
• ClinicalTrials.gov Identifier: NCT00001458
• Other Study ID Numbers: 950047; 95-H-0047
• First Posted: November 4, 1999
• Last Update Posted: March 12, 2021
• Last Verified: July 2020

• 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; Circulation; Peripheral Arterial Disease; Intermittent Claudication; Renal Vascular Disease; Uncontrolled Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases; Vascular Diseases