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

Baim Institute for Clinical Research17 sites in 1 country3,691 target enrollmentJune 2006

ConditionsCoronary Artery Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Diseases
Sponsor: Baim Institute for Clinical Research
Enrollment: 3691
Locations: 17
Primary Endpoint: 12-month Composite Major Adverse Cardiac Event (MACE)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

June 2006

End Date

December 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Baim Institute for Clinical Research

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is at least 18 years old.
•Subject requires single- or multi-vessel percutaneous coronary intervention (PCI) of de novo or restenotic target lesion (including in-stent restenotic lesions).
•Subject's lesion(s) is (are) amenable to stent treatment with currently available FDA-approved bare metal or drug eluting stents.
•Subject is an acceptable candidate for elective, urgent or emergency coronary artery bypass graft (CABG).
•Subject has clinical evidence of ischemic heart disease in terms of a positive functional study, or documented symptoms.
•Documented stable angina pectoris \[Canadian Cardiovascular Society Classification (CCS) 1, 2, 3, or 4\], unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), non-ST segment elevation myocardial infarction, or documented silent ischemia.
•Subject is willing and able to undergo percutaneous intervention at SOS hospital, if randomized to SOS study arm.
•Subject and the treating physician agree that the subject will comply with all follow-up evaluations.
•Subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site.
•The target lesion(s) is (are) de novo or restenotic (including in-stent restenotic) native coronary artery lesion(s) with greater than 50 and less than 100% stenosis (visual estimate), or the target lesion is an acute (less than 1 month) total occlusion as evidenced by clinical symptoms.

Exclusion Criteria

•The patient is pregnant or breastfeeding.
•Evidence of STEMI within 72 hours of the intended treatment on infarct related or non-infarct related artery.
•Cardiogenic shock on presentation or during current hospitalization.
•Left ventricular ejection fraction less than 20%.
•Known allergies to: aspirin, clopidogrel (Plavix) and ticlopidine (Ticlid), heparin, bivalirudin, stainless steel, or contrast agent (which cannot be adequately premedicated).
•A platelet count less than 75,000 cells/mm3 or greater than 700,000 cells/mm3 or a WBC less than 3,000 cells/mm
•Acute or chronic renal dysfunction (creatinine greater than 2.5 mg/dl or less than 150µmol/L).
•Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials).
•Prior participation in this study.
•Within 30 days prior to the index study procedure, the subject has undergone a previous coronary interventional procedure of any kind. Note: This exclusion criterion does not apply to post-STEMI patients.