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

Resource links provided by NLM:


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

  Show 40 Study Locations
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 Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Coronary Stenosis

ClinicalTrials.gov processed this record on July 29, 2014