Structural Heart Disease Clinical Trial
Official title:
Catheter-Based Treatment of Cardiovascular Disease in Patients
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.
The NHLBI is developing novel minimally invasive catheter-based treatments for cardiovascular
disease. These investigational treatments require that physicians, nurses and technical staff
maintain and expand their technical skills in the conduct of conventional catheter-based
treatments.
This protocol permits treatment of patients with cardiovascular diseases who are not
necessarily eligible to participate in existing clinical research protocols, but who are of
medical interest for the purpose of training professional staff, or who may be eligible for
adjunctive investigational imaging during clinical treatment. Efforts will be made to offer
treatment to patients with limited financial resources or with limited access to specialty
health care.
This protocol also provides a mechanism to offer catheter-based treatment of cardiovascular
disease to patients, so that they may participate in technical development protocols in
cardiovascular intervention or in cardiovascular imaging.
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