PROSPECT: An Imaging Study in Patients With Unstable Atherosclerotic Lesions
- Conditions
- Coronary RestenosisCoronary DiseaseCoronary Artery Disease
- Registration Number
- NCT00180466
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
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.
- Detailed Description
To identify in patients presenting with ACS imaging modalities and/or serologic markers of inflammation which may aid in the identification of non-flow obstructing lesions with an increased risk for future acute coronary events. This study will ascertain the prevalence and clinical significance of non-flow obstructing lesions, which subsequently result in acute coronary events - defined as vulnerable plaque. The safety of regional imaging of non-culprit lesions in ACS patients will also be assessed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 697
-
Acute cardiac pain, or angina equivalent, consistent with unstable angina or myocardial infarction, lasting greater than 10 minutes duration within the past 72 hours.
-
Patient must have evidence of an ACS requiring catheterization documented by the presence of any one of the following conditions:
- Elevated enzymes (CK-MB or troponin I or troponin T greater than upper limits of normal).
- 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.
- Transient ST elevation of >1 mm in 2 or more contiguous leads lasting <30 minutes (otherwise same criteria as above).
- 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
- Patient has had a documented acute ST-segment elevation myocardial infarction within the past 24 hours.
- Known serum creatinine > 2.5 mg/dl.
- Decompensated hypotension or heart failure requiring intubation, inotropes, intravenous diuretics or intraaortic balloon counterpulsation.
- 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.
- Presence of cardiac implants (i.e. implantable defibrillators); however, prior implantation of pacemaker or biventricular pacemaker is permitted.
- Presence of cardiogenic shock.
- Patient has a known left ventricular ejection fraction <30%.
- Refractory ventricular arrhythmia requiring either intravenous pharmacologic treatment or defibrillator therapy (e.g. ventricular tachycardia or fibrillation).
- Acute conduction system disease requiring temporary pacemaker insertion.
- Patient has had a recent (within 6 months) PCI unless the patient is undergoing a staged procedure for dual vessel treatment.
- 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..
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (40)
Good Samaritan Hospital
🇺🇸San Jose, California, United States
Stanford Hospital and Clinics
🇺🇸Stanford, California, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Mt. Sinai Hospital
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
EMH Regional Medical Center
🇺🇸Elyria, Ohio, United States
Pinnacle Health at Harrisburg Hospital
🇺🇸Harrisburg, Pennsylvania, United States
OLV-Hospital Aalst
🇧🇪Aalst, Belgium
A.Z. Middleheim
🇧🇪Antwerpen, Belgium
Skejby Sygehus
🇩🇰Århus, Denmark
CHU Jean Minjoz
🇫🇷Besançon, France
Kerckhoff Klinik
🇩🇪Bad Nauheim, Germany
Herzzentrum Klinik für Kardiologie
🇩🇪Bad Oeynhausen, Germany
Clinique Pasteur
🇫🇷Toulouse, France
Universitäres Herz- und Gefäßzentrum Hamburg
🇩🇪Hamburg, Germany
Azienda Ospedaliera S. Orsola-Malpighi
🇮🇹Bologna, Italy
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
University Hospital Krakow
🇵🇱Krakow, Poland
Hospital Santa Cruz
🇪🇸Carnaxide, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital do Meixoeiro
🇪🇸Vigo Pontevedra, Spain
Sahlgrenska Sjukhuset
🇸🇪Göteborg, Sweden
University Hospital Zürich
🇨🇭Zürich, Switzerland
University Hospital Gregorio Maranon
🇪🇸Madrid, Spain
The London Chest Hospital
🇬🇧London, United Kingdom
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Sisters of Charity Providence Hospitals
🇺🇸Columbia, South Carolina, United States
St. Thomas Hospital
🇺🇸Nashville, Tennessee, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
St. Vincent's Hospital and Health Care Center
🇺🇸Indianapolis, Indiana, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
North Mississippi Medical Center
🇺🇸Tupelo, Mississippi, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States