The MASS COMM Post-Randomization Phase Cohort Study

Status Completed

Clinical Trial Summary

The primary objective of the Post-Randomization Phase Cohort Study is to continue to assess the safety of non-emergency PCI performed at hospitals without cardiac surgery on-site in patients with myocardial ischemia (other than ST-segment elevation myocardial infarction [STEMI]).

Clinical Trial Description

The MASS COMM Post-Randomization Phase Cohort Study ("Cohort Study" is a prospective, multi-center, single-arm study of non-emergency PCI performed at non-SOS hospitals in patients with myocardial ischemia (other than STEMI). The Cohort Study is designed to allow non-SOS hospitals to continue to perform non-emergency PCI after enrollment to the MASS COMM trial is completed and before the 30-day and 12-month results are available.

Specifically, all eligible subjects, after enrollment to the MASS COMM randomized controlled trial is completed and before the final results are available and a decision is reached by the MA-DPH, will be consented and enrolled into this Cohort Study. Subjects will be followed through 30 days post procedure. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02072421
Study type	Interventional
Source	Harvard Clinical Research Institute
Contact
Status	Completed
Phase	N/A
Start date	October 2011
Completion date	October 2013

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