PROSPECT: An Imaging Study in Patients With Unstable Atherosclerotic Lesions

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Completed

CT.gov ID

NCT00180466

Collaborator

(none)

697

Enrollment

Locations

Duration (Months)

17.4

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease Coronary Artery Disease Coronary Restenosis

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 Design

Study Type:

Observational

Actual Enrollment :

697 participants

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

Study Start Date :

Oct 1, 2004

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Outcome Measures

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 [Inhospital, 30 days, 180 days, 1 year and then yearly for up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:
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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Joseph's Hospital and Medical Center	Phoenix	Arizona	United States	85013
2	Good Samaritan Hospital	San Jose	California	United States	95124
3	Stanford Hospital and Clinics	Stanford	California	United States	94305
4	Washington Hospital Center	Washington	District of Columbia	United States	20010
5	Piedmont Hospital	Atlanta	Georgia	United States	30309
6	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
7	St. Vincent's Hospital and Health Care Center	Indianapolis	Indiana	United States	46290
8	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
9	Mayo Clinic	Rochester	Minnesota	United States	55905
10	North Mississippi Medical Center	Tupelo	Mississippi	United States	38801
11	St. Luke's Hospital	Kansas City	Missouri	United States	85006
12	Mt. Sinai Hospital	New York	New York	United States	10029
13	Columbia University Medical Center	New York	New York	United States	10032
14	Presbyterian Hospital	Charlotte	North Carolina	United States	28204
15	The Christ Hospital	Cincinnati	Ohio	United States	45219
16	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
17	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
18	EMH Regional Medical Center	Elyria	Ohio	United States	44035
19	Pinnacle Health at Harrisburg Hospital	Harrisburg	Pennsylvania	United States	17101
20	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
21	Sisters of Charity Providence Hospitals	Columbia	South Carolina	United States	29204
22	St. Thomas Hospital	Nashville	Tennessee	United States	37205
23	OLV-Hospital Aalst	Aalst		Belgium
24	A.Z. Middleheim	Antwerpen		Belgium
25	Skejby Sygehus	Århus		Denmark
26	CHU Jean Minjoz	Besançon		France
27	Clinique Pasteur	Toulouse		France
28	Kerckhoff Klinik	Bad Nauheim		Germany
29	Herzzentrum Klinik für Kardiologie	Bad Oeynhausen		Germany
30	Universitäres Herz- und Gefäßzentrum Hamburg	Hamburg		Germany
31	Azienda Ospedaliera S. Orsola-Malpighi	Bologna		Italy
32	Erasmus Medical Center	Rotterdam		Netherlands
33	University Hospital Krakow	Krakow		Poland
34	Hospital Santa Cruz	Carnaxide		Spain
35	Hospital Clinico San Carlos	Madrid		Spain
36	University Hospital Gregorio Maranon	Madrid		Spain
37	Hospital do Meixoeiro	Vigo Pontevedra		Spain
38	Sahlgrenska Sjukhuset	Göteborg		Sweden
39	University Hospital Zürich	Zürich		Switzerland
40	The London Chest Hospital	London		United Kingdom

Sponsors and Collaborators

Abbott Medical Devices

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