Coronary Artery Disease Clinical Trial
Official title:
Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT) An Imaging Study in Patients With Unstable Atherosclerotic Lesions
Verified date | May 2010 |
Source | Abbott Vascular |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
PROSPECT is a multi-center prospective registry of Acute Coronary Syndromes (ACS) patients with single or double vessel coronary artery disease. Approximately 700 patients with ACS will be enrolled into the study at sites in the United States and European Union.
Status | Completed |
Enrollment | 697 |
Est. completion date | July 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Acute cardiac pain, or angina equivalent, consistent with unstable angina or myocardial infarction, lasting greater than 10 minutes duration within the past 72 hours. 2. Patient must have evidence of an ACS requiring catheterization documented by the presence of any one of the following conditions: 1. Elevated enzymes (CK-MB or troponin I or troponin T greater than upper limits of normal). 2. ST depression of >1 mm in 2 or more contiguous leads measured at 40 ms after the J point, in the absence of left ventricular hypertrophy, bundle branch block, paced rhythms, pre-excitation or other ECG artifacts or confounding conditions. 3. Transient ST elevation of >1 mm in 2 or more contiguous leads lasting <30 minutes (otherwise same criteria as above). 4. ST elevation myocardial infarction with onset >24 hours previously, diagnosed with the typical triad of nitrate unresponsive chest pain lasting >30 minutes, ST elevation of >1 mm in 2 or more contiguous leads or new left bundle branch block, and rise and fall of CK-MB isoenzymes. Key Clinical Exclusion Criteria: 1. Patient has had a documented acute ST-segment elevation myocardial infarction within the past 24 hours. 2. Known serum creatinine > 2.5 mg/dl. 3. Decompensated hypotension or heart failure requiring intubation, inotropes, intravenous diuretics or intraaortic balloon counterpulsation. 4. Patient has a known hypersensitivity, allergy or contraindication to any of the following: aspirin, heparin, clopidogrel, and ticlopidine or to contrast that cannot be adequately pre-medicated. 5. Presence of cardiac implants (i.e. implantable defibrillators); however, prior implantation of pacemaker or biventricular pacemaker is permitted. 6. Presence of cardiogenic shock. 7. Patient has a known left ventricular ejection fraction <30%. 8. Refractory ventricular arrhythmia requiring either intravenous pharmacologic treatment or defibrillator therapy (e.g. ventricular tachycardia or fibrillation). 9. Acute conduction system disease requiring temporary pacemaker insertion. 10. Patient has had a recent (within 6 months) PCI unless the patient is undergoing a staged procedure for dual vessel treatment. 11. Patient has other medical illness (i.e., cancer or congestive heart failure) or recent history of substance abuse that may cause non-compliance with the Investigational Plan, confound the data interpretation or is associated with an anticipated limited life expectancy less than one year.. 12. Prior participation in this study or patient is currently enrolled in another investigational use device or drug study that has not reached its primary endpoint. If the patient is enrolled in another study that is not investigational, required visits for that trial must not interfere with the conduct of this trial. |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Belgium | OLV-Hospital Aalst | Aalst | |
Belgium | A.Z. Middleheim | Antwerpen | |
Denmark | Skejby Sygehus | Århus | |
France | CHU Jean Minjoz | Besançon | |
France | Clinique Pasteur | Toulouse | |
Germany | Kerckhoff Klinik | Bad Nauheim | |
Germany | Herzzentrum Klinik für Kardiologie | Bad Oeynhausen | |
Germany | Universitäres Herz- und Gefäßzentrum Hamburg | Hamburg | |
Italy | Azienda Ospedaliera S. Orsola-Malpighi | Bologna | |
Netherlands | Erasmus Medical Center | Rotterdam | |
Poland | University Hospital Krakow | Krakow | |
Spain | Hospital Santa Cruz | Carnaxide | |
Spain | Hospital Clinico San Carlos | Madrid | |
Spain | University Hospital Gregorio Maranon | Madrid | |
Spain | Hospital do Meixoeiro | Vigo Pontevedra | |
Sweden | Sahlgrenska Sjukhuset | Göteborg | |
Switzerland | University Hospital Zürich | Zürich | |
United Kingdom | The London Chest Hospital | London | |
United States | Piedmont Hospital | Atlanta | Georgia |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Presbyterian Hospital | Charlotte | North Carolina |
United States | Northwestern Memorial Hospital | Chicago | Illinois |
United States | The Christ Hospital | Cincinnati | Ohio |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Sisters of Charity Providence Hospitals | Columbia | South Carolina |
United States | Riverside Methodist Hospital | Columbus | Ohio |
United States | EMH Regional Medical Center | Elyria | Ohio |
United States | Pinnacle Health at Harrisburg Hospital | Harrisburg | Pennsylvania |
United States | St. Vincent's Hospital and Health Care Center | Indianapolis | Indiana |
United States | St. Luke's Hospital | Kansas City | Missouri |
United States | St. Thomas Hospital | Nashville | Tennessee |
United States | Columbia University Medical Center | New York | New York |
United States | Mt. Sinai Hospital | New York | New York |
United States | St. Joseph's Hospital and Medical Center | Phoenix | Arizona |
United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Good Samaritan Hospital | San Jose | California |
United States | Stanford Hospital and Clinics | Stanford | California |
United States | North Mississippi Medical Center | Tupelo | Mississippi |
United States | Washington Hospital Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Abbott Vascular |
United States, Belgium, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom,
Ostuka Masato; Bruining N.; Van Pelt, N.; et.al. Three-dimensional quantification of coronary plaque burden by 64-slice computed tomography: A PROS-PECT-MSCT substudy. Journal of the American College of Cardiology 49(9, Suppl. A): p 114A MAR 6 2007
Stone Gregg W, Lansky A.; Carlier S. et. al. A prospective, natural history study of multimodality invasive imaging to characterize vulnerable plaque: First report of the baseline findings from the PROSPECT trial. Journal of the American College of Cardio
Tanaka K; Carlier SG; Mintz GS; et.al. High risk fibroatheroma lesions are remote from the minimal lumen area site: A virtual histology IVUS analysis from the PROSPECT study AMERICAN JOURNAL OF CARDIOLOGY, 2006, V 98, N8A, P 94M-94M.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary outcome variable is Non-culprit Lesion Related Major Adverse Cardiac Events; defined as the composite of cardiac death, cardiac arrest, MI, ACS, revascularization by CABG, PCI, or rehospitalization by CABG or PCI or rehospitalization for angina | Inhospital, 30 days, 180 days, 1 year and then yearly for up to 5 years | Yes |
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