Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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). ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


NCT number NCT01116882
Study type Interventional
Source Harvard Clinical Research Institute
Contact
Status Completed
Phase N/A
Start date June 2006
Completion date December 2012

See also
  Status Clinical Trial Phase
Completed NCT00328315 - Cardiac SPECT With Rotating Slant Hole Collimator
Recruiting NCT02257710 - BIOFLOW-III UK Satellite Registry Orsiro Stent System N/A
Active, not recruiting NCT02273648 - BIOTRONIK - BIOFLOW-III Registry French Satellite N/A
Recruiting NCT01157455 - A Registry To Evaluate Safety And Effectiveness Of Everolimus Drug Eluting Stent For Coronary Revascularization Phase 4
Completed NCT02028728 - BIOFLOW III Satellite-Italy Orsiro Stent System N/A
Completed NCT02813473 - SYNTAX III REVOLUTION Trial: A Randomized Study Investigating the Use of CT Scan and Angiography of the Heart to Help the Doctors Decide Which Method is the Best to Improve Blood Supply to the Heart in Patients With Complex Coronary Artery Disease
Completed NCT05853250 - Clinical and Hospital Stay Effects of Reiki and Manual Therapy After Open Heart Surgery N/A
Recruiting NCT02635230 - What is the Optimal antiplatElet and Anticoagulant Therapy in Patients With Oral Anticoagulation Undergoing revasculariSaTion 2.
Completed NCT00920283 - COMPETE: A Clinical Evaluation of Chrono Carbostent Carbofilmâ„¢ Coated Stent N/A
Completed NCT01700075 - Physical and Chemical Study of Atherosclerosis Mechanisms Phase 4
Completed NCT00607178 - The Efficacy of Influenza Vaccine in Reducing Cardiovascular Events in Patients With Coronary Artery Diseases Phase 2/Phase 3
Completed NCT00607217 - The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases Phase 2/Phase 3
Not yet recruiting NCT05486780 - The Effect of Digital Window on Day and Night Perception Status and Sleep Quality in Intensive Care Patients N/A
Terminated NCT01665248 - Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina N/A
Terminated NCT01612819 - DXR Stent(Previous Cilotax) Implantation Registry N/A
Active, not recruiting NCT01226355 - NOYA CoCr Biodegradable Coating Sirolimus-Eluting Coronary Stent System N/A
Recruiting NCT02247492 - BIOFLOW-III VIP Russia Registry Orsiro Stent System