Percutaneous Coronary Intervention (PCI) Outcomes in Community Versus Tertiary Settings



Status:Archived
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:June 2006
End Date:December 2012

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A Randomized Trial to Compare Percutaneous Coronary Intervention Between Massachusetts Hospitals With Cardiac Surgery-On-Site and Community Hospitals Without Cardiac Surgery-On-Site


The primary objective of the trial is to compare the acute safety and long term outcomes
between hospitals with cardiac surgery on-site (SOS hospitals) and hospitals without cardiac
surgery on-site (non-SOS hospitals) for patients with ischemic heart disease treated with
elective percutaneous coronary intervention (PCI) (stable angina, acute coronary syndrome,
or non-Q wave MI) presenting to non-SOS hospitals.


The MASS COMM trial is a prospective, multi-center, randomized, controlled two-arm trial of
PCI performed at non-SOS hospitals (non-SOS-PCI arm) versus PCI performed at SOS hospitals
(SOS-PCI arm). The trial is designed to reject the null-hypothesis of inferiority, and
thereby show the non-inferiority of the non-SOS-PCI arm to the SOS-PCI arm.

Specifically, 3690 subjects will be enrolled in a multi-center, randomized, controlled trial
(RCT), in which eligible subjects will be consented and randomized in a 3:1 ratio at the
non-SOS hospitals for PCI to be performed at either the enrolling non-SOS hospital (3
chances out of 4) or a corresponding SOS hospital (1 chance out of 4).


We found this trial at
15
sites
1 Boston Medical Center Pl
Boston, Massachusetts 02118
617.638.8000
Boston Med Center Boston Medical Center (BMC) is a 496-bed academic medical center located in...
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Boston, MA
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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Boston, Massachusetts 02111
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Boston, MA
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Brighton, Massachusetts 02135
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Brighton, MA
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Brockton, Massachusetts 02301
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Brockton, MA
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Brockton, Massachusetts 02301
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Brockton, MA
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Burlington, Maine 01805
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Burlington, ME
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850 Boylston Street
Chestnut Hill, Massachusetts 02467
1-800-BWH-9999
Brigham & Women's Hospital Women's Health Center At Brigham and Women
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Chestnut Hill, MA
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Framingham, Massachusetts 01702
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Framingham, MA
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Lowell, Massachusetts 01852
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Lowell, MA
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Lowell, Massachusetts 01854
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Lowell, MA
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Melrose, Massachusetts 02176
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Melrose, MA
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Norwood, Massachusetts 02062
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Norwood, MA
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South Weymouth, Massachusetts 02190
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South Weymouth, MA
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