Catheter-Based Treatment of Cardiovascular Disease

NCT00380016 | Completed

• 2 other identifiers: 06020306-H-0203
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Coronary Artery Disease; Obstructive Peripheral Artery Disease; Structural Heart Disease

Keywords

Angioplasty; Stent; Coronary Artery Disease; Peripheral Artery Disease; Percutaneous Coronary Intervention; CAD; PAD; Cardiovascular Disease

Interventions

Percutaneous Transluminal Angioplasty PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult men and women with cardiovascular disease will be eligible to participate in this training protocol.
• Adult men and women, age 18 years or older
• 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

You may not qualify if:

• Subjects are excluded if catheter-based therapy is unsuitable, in the opinion of the operating cardiologist.
• Pregnant women
• Inability of patient or surrogate to provide informed consent.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Peripheral Arterial Disease; Cardiovascular Diseases

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Atherosclerosis; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 22, 2006
• First Posted: September 25, 2006
• Study Start: September 20, 2006
• Study Completion: March 3, 2009
• Last Updated: July 2, 2017

Record last verified: 2009-03-03

Locations

US (1)