Protocol Number: 06-H-0203

Title:

Catheter-Based Treatment of Cardiovascular Disease in Patients

Number:

06-H-0203

Summary:

This study offers catheter-based treatment of heart or artery disease. This protocol permits treatment of patients with cardiovascular diseases who may not be eligible to participate in current research protocols. The treatment offered in this protocol is not experimental, but rather standard treatment provided in most large referral hospitals in the United States.

Patients 18 years of age and older who are candidates for catheter-based treatment of obstructive artery disease, including blocked blood flow in a coronary artery (artery to the heart) or in an artery of the arm, leg, brain or kidney may be eligible for this study. Candidates are screened with a general medical evaluation that may include blood tests, magnetic resonance imaging, and monitoring of heart rate and rhythm.

Participants undergo angioplasty or stenting for blockage in an artery to the heart or an artery of the arm, leg, brain or kidney. The procedure uses a balloon-tipped catheter to open the blocked artery and likely requires permanent implantation of a metal tube (stent) to improve blood flow through the vessel. During the procedure, the patient is given a sedative and pain medication, if needed.

Sponsoring Institute:

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Adult men and women with cardiovascular disease will be eligible to participate in this training protocol.

1. Adult men and women, age 18 years or older

2. Eligible for catheter-based treatment. A representative list of diseases and catheter-based treatments includes:

-Obstructive coronary artery disease manifest as myocardial infarction, angina pectoris, angina-equivalent, ischemic dysrhythmia, or evidence of ischemia or viability on non-invasive cardiovascular testing

-Obstructive peripheral artery disease manifest as intermittent claudication, limb-threatening ischemia, visceral ischemia, or obstructive extracranial cerebrovascular disease

-Structural heart disease including patent foramen ovale, atrial septal defect, ventricular septal defect, patent ductus arteriosus, and valvular heart disease

EXCLUSION CRITERIA:

Subjects are excluded if catheter-based therapy is unsuitable, in the opinion of the operating cardiologist.

1. Pregnant women

2. Inability of patient or surrogate to provide informed consent.

Special Instructions:

Currently Not Provided

Keywords:

Angioplasty

Stent

Coronary Artery Disease

Peripheral Artery Disease

Percutaneous Coronary Intervention

Recruitment Keyword(s):

Coronary Artery Disease

CAD

Peripheral Artery Disease

PAD

Cardiovascular Disease

Condition(s):

Obstructive Coronary Artery Disease

Obstructive Peripheral Artery Disease

Structural Heart Disease

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Procedure/Surgery: Percutaneous Transluminal Angioplasty

Supporting Site:

National Heart, Lung and Blood Institute

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s): Not Provided

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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