Coronary Artery Disease Clinical Trial
Official title:
Long-Term Follow-Up of Selected Patients Enrolled in Phase 3 Clinical Trial 127-014 Using PB127 Ultrasound Imaging Agent
| Verified date | July 2008 |
| Source | Point Biomedical |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Observational |
The purpose of this study is to collect longer term follow-up information concerning health and survival on selected patients who received PB127 for injectable suspension in the pivotal trial (127-014).
| Status | Terminated |
| Enrollment | 300 |
| Est. completion date | July 2008 |
| Est. primary completion date | July 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: Patients enrolled in Protocol 127-014 who 1. Were enrolled in Stratum 1 2. Did not undergo angiography during study evaluation 3. Did not have a clinical oucome during the initial 6 month follow-up period as described in Protocol 127-014. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Androscoggin Cardiovascular Associates | Auburn | Maine |
| United States | Austin Heart | Austin | Texas |
| United States | Seton Healthcare Network Brackenridge Hospital | Austin | Texas |
| United States | Brigham & Women's Hosptial | Boston | Massachusetts |
| United States | Connecticut Clinical Research | Bridgeport | Connecticut |
| United States | Cardiovascular Associates of the Peninsula | Burlingame | California |
| United States | Northwestern University Feinberg School of Medicine | Chicago | Illinois |
| United States | The Cleveland Clinic Foundation Department of Cardiology | Cleveland | Ohio |
| United States | Ohio State University College of Medicine and Public Health | Columbus | Ohio |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Consultants in Cardiology | Fort Worth | Texas |
| United States | University of Texas Division of Cardiology | Galveston | Texas |
| United States | Carolina Cardiology Associates | High Point | North Carolina |
| United States | Methodist DeBakery Heart Center Cardiovascular Imaging Institute | Houston | Texas |
| United States | University of Texas Health Science Center Memorial Hermann Heart & Vascular Institute | Houston | Texas |
| United States | Cardiovascular Consultants | Kansas City | Missouri |
| United States | Long Beach VA Medical Center Cardiology Division | Long Beach | California |
| United States | Cedars Sinai Medical Center Division of Cardiology | Los Angeles | California |
| United States | North Shore University Hospital | Manhasset | New York |
| United States | St. Luke's Roosevelt Hospital Echocardiography Lab | New York | New York |
| United States | Alfieri Cardiology | Newark | Delaware |
| United States | Midwest Cardiology Associates | Overland Park | Kansas |
| United States | Western Baptist Hospital The Heart Group | Paducah | Kentucky |
| United States | University of Pittsburgh Cardiovascular Institute | Pittsburgh | Pennsylvania |
| United States | Mayo Clinic Department of Cardiology | Rochester | Minnesota |
| United States | Sutter Roseville Medical Center | Roseville | California |
| United States | University of California San Diego Division of Cardiology | San Diego | California |
| United States | San Francisco VA Medical Center NCIRE | San Francisco | California |
| United States | Harborview Medical Center Department of Cardiology | Seattle | Washington |
| United States | The Center for Cardiovascular Studies Kramer & Crouse Cardiology | Shawnee Mission | Kansas |
| United States | Maine Cardiology Associates | South Portland | Maine |
| United States | Heart Clinics Northwest | Spokane | Washington |
| United States | Inland Cardiology | Spokane | Washington |
| United States | Northwest Cardiovascular Research Institute Spokane Cardiology | Spokane | Washington |
| United States | St. Louis University Medical Center | St. Louis | Missouri |
| United States | Stonybrook University Medical Center | Stonybrook | New York |
| United States | University of Arizona Saver Heart Clinic | Tucson | Arizona |
| United States | Washington Hospital Center Cardiovascular Research Institute | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Point Biomedical |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To collect longer-term follow-up clinical information on selected patients enrolled in Protocol 127-014 | 1 year | No |
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