NCT01116882

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,691

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 5, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

July 8, 2014

Completed
Last Updated

April 7, 2015

Status Verified

March 1, 2015

Enrollment Period

6 years

First QC Date

April 29, 2010

Results QC Date

June 6, 2014

Last Update Submit

March 18, 2015

Conditions

Coronary Artery Diseases

Keywords

PCIheart diseaseischemic heart disease

Outcome Measures

Primary Outcomes (2)

  • 30-day Composite Major Adverse Cardiac Event (MACE)

    30 days

  • 12-month Composite Major Adverse Cardiac Event (MACE)

    12 month

Secondary Outcomes (15)

  • All Cause Mortality at 30 Days

    30 days

  • Ischemia-driven Target Lesion Revascularization

    30 days

  • Ischemia-driven Target Lesion Revascularization

    12 months

  • Rate of Stent Thrombosis

    12 months

  • Any Repeat Revascularization

    12 months

  • +10 more secondary outcomes

Study Arms (2)

SOS

ACTIVE COMPARATOR

Patients randomized to the SOS arm are transferred to tertiary hospitals for their PCI procedure.

Procedure: PCI

Non-SOS

EXPERIMENTAL

Patients in the non-SOS arm are randomized to stay at the community hospitals for their PCI procedure.

Procedure: PCI

Interventions

PCIPROCEDURE
Non-SOSSOS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Target lesions(s) is (are) located in an infarct (if not treated with primary PCI) or non-infarct-related artery with a 70% or greater stenosis (by visual estimate) more than 72 hours following the ST segment elevation myocardial infarction (STEMI).

You may not qualify if:

  • 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/mm3.
  • 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.
  • Stroke or transient ischemic attack within the prior 3 months.
  • Active peptic ulcer or upper gastrointestinal bleeding within the prior 3 months.
  • Subject has active sepsis.
  • Unprotected left main coronary artery disease (stenosis greater than 50%).
  • In the investigator's opinion, subject has a co-morbid condition(s) that could limit the life expectancy to less than one year, or limit the subject's ability to participate in the study or comply with follow-up requirements or impact the scientific integrity of the study.
  • Subject has normal or insignificant coronaries (i.e. coronary lesion(s) less than 50% stenosis).
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Tufts New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Beth Israel Deaconnes Medical Center

Boston, Massachusetts, 02215, United States

Location

Caritas St. Elizabeth's Hospital

Brighton, Massachusetts, 02135, United States

Location

Brockton Hospital

Brockton, Massachusetts, 02301, United States

Location

Caritas Good Samaritan Medical Center

Brockton, Massachusetts, 02301, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Metrowest Medical Center

Framingham, Massachusetts, 01702, United States

Location

Lawrence General Hospital

Haverhill, Massachusetts, 01803, United States

Location

Saints Memorial Medical Center

Lowell, Massachusetts, 01853, United States

Location

Lowell General Hospital

Lowell, Massachusetts, 01854, United States

Location

Melrose Wakefield Hospital

Melrose, Massachusetts, 02176, United States

Location

Caritas Holy Family Hospital

Methuen, Massachusetts, 01844, United States

Location

Caritas Norwood Hospital

Norwood, Massachusetts, 02062, United States

Location

South Shore Hospital

Weymouth, Massachusetts, 02190, United States

Location

Related Publications (2)

  • Jacobs AK, Normand SL, Massaro JM, Cutlip DE, Carrozza JP Jr, Marks AD, Murphy N, Romm IK, Biondolillo M, Mauri L; MASS COMM Investigators. Nonemergency PCI at hospitals with or without on-site cardiac surgery. N Engl J Med. 2013 Apr 18;368(16):1498-508. doi: 10.1056/NEJMoa1300610. Epub 2013 Mar 11.

    PMID: 23477625DERIVED

  • Mauri L, Normand SL, Pencina M, Cutlip DE, Jeon C, Dreyer P, Kuntz RE, Baim DS, Jacobs AK. Rationale and design of the MASS COMM trial: A randomized trial to compare percutaneous coronary intervention between MASSachusetts hospitals with cardiac surgery on-site and COMMunity hospitals without cardiac surgery on-site. Am Heart J. 2011 Nov;162(5):826-31. doi: 10.1016/j.ahj.2011.08.018.

    PMID: 22093197DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseHeart DiseasesMyocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary DiseaseCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Results Point of Contact

Title
Priscilla Driscoll-Shemp
Organization
Harvard Clinical Research Institute
priscilla.driscoll-shempp@hcri.harvard.edu
617-307-5200

Study Officials

  • Alice K Jacobs, MD

    Boston University School of Medicine , Boston Medical Center

    PRINCIPAL INVESTIGATOR

  • Sharon-Lise Normand, Ph.D.

    Harvard Medical School (HMS and HSDM)

    PRINCIPAL INVESTIGATOR

  • Laura Mauri, M.D.

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2010

First Posted

May 5, 2010

Study Start

June 1, 2006

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

April 7, 2015

Results First Posted

July 8, 2014

Record last verified: 2015-03

Locations

US(17)