PROSPECT: An Imaging Study in Patients With Unstable Atherosclerotic Lesions

May 24, 2010 updated by: Abbott Medical Devices

Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT) An Imaging Study in Patients With Unstable Atherosclerotic Lesions

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

697

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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).

Description

Inclusion Criteria:

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:
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:

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Inhospital, 30 days, 180 days, 1 year and then yearly for up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

Principal Investigator: Patrick Serruys, MD, PhD, Thoraxcenter, Erasmus University, Rotterdam, The Netherlands
Principal Investigator: Bernard de Bruyne, MD, Cardiovascular Center, OLV Hospital, Aalst, Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

July 1, 2009

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria