PROSPECT: An Imaging Study in Patients With Unstable Atherosclerotic Lesions

This study has been completed.
Sponsor:
Information provided by:
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00180466
First received: September 13, 2005
Last updated: May 24, 2010
Last verified: May 2010
  Purpose

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.


Condition
Coronary Disease
Coronary Artery Disease
Coronary Restenosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT) An Imaging Study in Patients With Unstable Atherosclerotic Lesions

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • 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 [ Time Frame: Inhospital, 30 days, 180 days, 1 year and then yearly for up to 5 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Aproximately 1 ML blood


Enrollment: 697
Study Start Date: October 2004
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients presenting with an Acute Coronary Syndrome that require catheterization and interventional treatment of a culprit lesion(s).

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180466

  Hide Study Locations
Locations
United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
Good Samaritan Hospital
San Jose, California, United States, 95124
Stanford Hospital and Clinics
Stanford, California, United States, 94305
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Indiana
St. Vincent's Hospital and Health Care Center
Indianapolis, Indiana, United States, 46290
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
North Mississippi Medical Center
Tupelo, Mississippi, United States, 38801
United States, Missouri
St. Luke's Hospital
Kansas City, Missouri, United States, 85006
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Mt. Sinai Hospital
New York, New York, United States, 10029
United States, North Carolina
Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
EMH Regional Medical Center
Elyria, Ohio, United States, 44035
United States, Pennsylvania
Pinnacle Health at Harrisburg Hospital
Harrisburg, Pennsylvania, United States, 17101
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Sisters of Charity Providence Hospitals
Columbia, South Carolina, United States, 29204
United States, Tennessee
St. Thomas Hospital
Nashville, Tennessee, United States, 37205
Belgium
OLV-Hospital Aalst
Aalst, Belgium
A.Z. Middleheim
Antwerpen, Belgium
Denmark
Skejby Sygehus
Århus, Denmark
France
CHU Jean Minjoz
Besançon, France
Clinique Pasteur
Toulouse, France
Germany
Kerckhoff Klinik
Bad Nauheim, Germany
Herzzentrum Klinik für Kardiologie
Bad Oeynhausen, Germany
Universitäres Herz- und Gefäßzentrum Hamburg
Hamburg, Germany
Italy
Azienda Ospedaliera S. Orsola-Malpighi
Bologna, Italy
Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Poland
University Hospital Krakow
Krakow, Poland
Spain
Hospital Santa Cruz
Carnaxide, Spain
Hospital Clinico San Carlos
Madrid, Spain
University Hospital Gregorio Maranon
Madrid, Spain
Hospital do Meixoeiro
Vigo Pontevedra, Spain
Sweden
Sahlgrenska Sjukhuset
Göteborg, Sweden
Switzerland
University Hospital Zürich
Zürich, Switzerland
United Kingdom
The London Chest Hospital
London, United Kingdom
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Gregg Stone, MD Columbia University
Principal Investigator: Patrick Serruys, MD, PhD Thoraxcenter, Erasmus University, Rotterdam, The Netherlands
Principal Investigator: Bernard de Bruyne, MD Cardiovascular Center, OLV Hospital, Aalst, Belgium
  More Information

Publications:
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 Cardiology 49(9, Suppl. B): p 19B MAR 6 2007.
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
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Matt Kiely, Abbott Vascular
ClinicalTrials.gov Identifier: NCT00180466     History of Changes
Other Study ID Numbers: 04-800
Study First Received: September 13, 2005
Last Updated: May 24, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Abbott Vascular:
drug eluting stents
stents
angioplasty
coronary artery disease
total coronary occlusion
coronary artery restenosis
stent thrombosis
vascular disease
myocardial ischemia
coronary artery stenosis

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Coronary Stenosis

ClinicalTrials.gov processed this record on September 16, 2014