NCT01116882

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,691 (actual)
• Sponsor: Baim Institute for Clinical Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Coronary Artery Diseases

Interventions

Type	Name	Description
PROCEDURE	PCI

Timeline

• Start date: 2006-06-01
• Primary completion: 2012-06-01
• Completion: 2012-12-01
• First posted: 2010-05-05
• Last updated: 2015-04-07
• Results posted: 2014-07-08

Locations

17 sites across 1 country: United States