Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
Brockton Hospital
Good Samaritan Hospital Medical Center, New York
Norwood Hospital
Holy Family Hospital
Lawrence General Hospital
Lowell General Hospital
Melrose Wakefield Hospital
Metro West Medical Center
Saints Memorial Medical Center
South Shore Hospital
Information provided by:
Harvard Clinical Research Institute
ClinicalTrials.gov Identifier:
NCT01116882
First received: April 29, 2010
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Coronary Artery Diseases
Procedure: PCI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Randomized Trial to Compare Percutaneous Coronary Intervention Between Massachusetts Hospitals With Cardiac Surgery-On-Site and Community Hospitals Without Cardiac Surgery-On-Site

Resource links provided by NLM:


Further study details as provided by Harvard Clinical Research Institute:

Primary Outcome Measures:
  • 30-day Composite Major Adverse Cardiac Event (MACE) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • 12-month Composite Major Adverse Cardiac Event (MACE) [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All Cause Mortality at 30 Days [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Ischemia-driven Target Lesion Revascularization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Ischemia-driven Target Lesion Revascularization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rate of Stent Thrombosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Any Repeat Revascularization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Emergency or Urgent Revascularization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Procedural Success [ Time Frame: Discharge ] [ Designated as safety issue: No ]
    Procedural success is defined as residual stenosis of the target lesion of less than 20%

  • Major Vascular Complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Complete Revascularization [ Time Frame: discharge ] [ Designated as safety issue: No ]
    Complete revascularization was defined as the successful treatment, according to the criteria of procedural success, of all epicardial vessels with more than 70% and less than 100% stenosis.

  • Met Indication Criteria for PCI [ Time Frame: discharge ] [ Designated as safety issue: No ]
    Included here are the number of treated lesions that met the class I or II recommendations for anatomical indications for PCI, according to the PCI guidelines fo the American College of Cardiology Foundation-American Heart Association-Society for Cardiovascular Angiography and Interventions.

  • All Cause Mortality at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Ischemia-driven Target Vessel Revascularization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Ischemia-driven Target Vessel Revascularization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rate of Stent Thrombosis [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Any Repeat Revascularization [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 3691
Study Start Date: June 2006
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SOS
Patients randomized to the SOS arm are transferred to tertiary hospitals for their PCI procedure.
Procedure: PCI
Experimental: Non-SOS
Patients in the non-SOS arm are randomized to stay at the community hospitals for their PCI procedure.
Procedure: PCI

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is at least 18 years old.
  2. Subject requires single- or multi-vessel percutaneous coronary intervention (PCI) of de novo or restenotic target lesion (including in-stent restenotic lesions).
  3. Subject's lesion(s) is (are) amenable to stent treatment with currently available FDA-approved bare metal or drug eluting stents.
  4. Subject is an acceptable candidate for elective, urgent or emergency coronary artery bypass graft (CABG).
  5. Subject has clinical evidence of ischemic heart disease in terms of a positive functional study, or documented symptoms.
  6. 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.
  7. Subject is willing and able to undergo percutaneous intervention at SOS hospital, if randomized to SOS study arm.
  8. Subject and the treating physician agree that the subject will comply with all follow-up evaluations.
  9. 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.
  10. 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.
  11. 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).

Lesions treated with PCI more than 72 hours following STEMI would be subject to the same protocol inclusion/exclusion criteria listed above and below with the exception that a target lesion of 70% or greater stenosis may be treated with or without symptoms or abnormal stress test).

Exclusion Criteria:

  1. The patient is pregnant or breastfeeding.
  2. Evidence of STEMI within 72 hours of the intended treatment on infarct related or non-infarct related artery.
  3. Cardiogenic shock on presentation or during current hospitalization.
  4. Left ventricular ejection fraction less than 20%.
  5. Known allergies to: aspirin, clopidogrel (Plavix) and ticlopidine (Ticlid), heparin, bivalirudin, stainless steel, or contrast agent (which cannot be adequately premedicated).
  6. 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.
  7. Acute or chronic renal dysfunction (creatinine greater than 2.5 mg/dl or less than 150µmol/L).
  8. 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).
  9. Prior participation in this study.
  10. 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.
  11. Stroke or transient ischemic attack within the prior 3 months.
  12. Active peptic ulcer or upper gastrointestinal bleeding within the prior 3 months.
  13. Subject has active sepsis.
  14. Unprotected left main coronary artery disease (stenosis greater than 50%).
  15. 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.
  16. Subject has normal or insignificant coronaries (i.e. coronary lesion(s) less than 50% stenosis).
  17. Any target vessel has evidence of:

    • excessive thrombus (e.g. requires target vessel thrombectomy)
    • tortuousity (greater than 60 degree angle) that makes it unsuitable for proper stent delivery and deployment,
    • heavy calcification.
  18. Any target lesion requires treatment with a device other than percutaneous transluminal coronary angioplasty (PTCA) prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
  19. Any lesion that is located in a saphenous vein graft, however, lesions located within the native vessel but accessed through the graft are eligible.
  20. The target vessel is in a "last remaining" epicardial vessel (e.g. greater than 2 non-target epicardial vessels and the bypass grafts to these territories [if present] are totally occluded).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116882

Locations
United States, Massachusetts
Tufts New England Medical Center
Boston, Massachusetts, United States, 02111
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconnes Medical Center
Boston, Massachusetts, United States, 02215
Caritas St. Elizabeth's Hospital
Brighton, Massachusetts, United States, 02135
Brockton Hospital
Brockton, Massachusetts, United States, 02301
Caritas Good Samaritan Medical Center
Brockton, Massachusetts, United States, 02301
Lahey Clinic
Burlington, Massachusetts, United States, 01805
Metrowest Medical Center
Framingham, Massachusetts, United States, 01702
Lawrence General Hospital
Haverhill, Massachusetts, United States, 01803
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
Saints Memorial Medical Center
Lowell, Massachusetts, United States, 01853
Melrose Wakefield Hospital
Melrose, Massachusetts, United States, 02176
Caritas Holy Family Hospital
Methuen, Massachusetts, United States, 01844
Caritas Norwood Hospital
Norwood, Massachusetts, United States, 02062
South Shore Hospital
Weymouth, Massachusetts, United States, 02190
Sponsors and Collaborators
Harvard Clinical Research Institute
Brockton Hospital
Good Samaritan Hospital Medical Center, New York
Norwood Hospital
Holy Family Hospital
Lawrence General Hospital
Lowell General Hospital
Melrose Wakefield Hospital
Metro West Medical Center
Saints Memorial Medical Center
South Shore Hospital
Investigators
Principal Investigator: Alice K Jacobs, MD Boston University School of Medicine , Boston Medical Center
Principal Investigator: Sharon-Lise Normand, Ph.D. Harvard Medical School
Principal Investigator: Laura Mauri, M.D. Brigham and Women's Hospital
  More Information

No publications provided by Harvard Clinical Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alice Jacobs, MD, Boston University Medical Center
ClinicalTrials.gov Identifier: NCT01116882     History of Changes
Other Study ID Numbers: DPH00
Study First Received: April 29, 2010
Results First Received: June 6, 2014
Last Updated: June 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Harvard Clinical Research Institute:
PCI
heart disease
ischemic heart disease

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014