PROSPECT: An Imaging Study in Patients With Unstable Atherosclerotic Lesions

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180466
• Other study ID #: 04-800
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: May 24, 2010
• Start date: October 2004
• Est. completion date: July 2009

Study information

• Verified date: May 2010
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• 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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Restenosis
• Myocardial Ischemia

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  France,  Germany,  Italy,  Netherlands,  Poland,  Spain,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (3)

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.

Outcome

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