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PROSPECT: An Imaging Study in Patients With Unstable Atherosclerotic Lesions | Clinical Trials | Clareo Health

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PROSPECT: An Imaging Study in Patients With Unstable Atherosclerotic Lesions

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

NCT00180466•Abbott Medical Devices

View on ClinicalTrials.gov

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.

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

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.
+2 more criteria

Locations (40)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Good Samaritan Hospital

San Jose, California, United States

Stanford Hospital and Clinics

Stanford, California, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Piedmont Hospital

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

St. Vincent's Hospital and Health Care Center

Indianapolis, Indiana, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

North Mississippi Medical Center

Tupelo, Mississippi, United States

Key Dates

Start Date

October 1, 2004

Primary Completion Date

June 1, 2009

Completion Date

July 1, 2009

Last Updated

May 25, 2010

Enrollment

697

ACTUAL participants

Conditions

Coronary DiseaseCoronary Artery DiseaseCoronary Restenosis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 25, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

PROSPECT: An Imaging Study in Patients With Unstable Atherosclerotic Lesions

Inclusion Criteria

Exclusion Criteria

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