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PROSPECT: An Imaging Study in Patients With Unstable Atherosclerotic Lesions
This study is ongoing, but not recruiting participants.
Sponsored by: Abbott Vascular
Information provided by: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00180466
  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

MedlinePlus related topics: Coronary Artery Disease
U.S. FDA Resources
Study Type: Observational
Study Design: 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

Biospecimen Description:

Aproximately 1 ML blood


Enrollment: 697
Study Start Date: October 2004
Estimated Study Completion Date: April 2011
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
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 Medical Center
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

Responsible Party: Abbott Vascular ( Matt Kiely )
Study ID Numbers: 04-800
Study First Received: September 13, 2005
Last Updated: October 29, 2008
ClinicalTrials.gov Identifier: NCT00180466  
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

Study placed in the following topic categories:
Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Constriction, Pathologic
Ischemia
Arteriosclerosis
Coronary Restenosis
Coronary Stenosis
Thrombosis
Coronary Disease
Coronary Occlusion
Coronary Artery Disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009