Coronary Artery Diseases Clinical Trial
Official title:
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).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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