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

April 29, 2010
June 6, 2014
June 2006
June 2012   (final data collection date for primary outcome measure)
  • 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 ]
  • The primary safety endpoint is the 30-day major adverse cardiac event (MACE) rate. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • The primary efficacy endpoint is the 12 month rate of MACE. [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01116882 on ClinicalTrials.gov Archive Site
  • 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 ]
  • All cause mortality at 30 days and 12 months. [ Time Frame: 30 days and 12 months ] [ Designated as safety issue: Yes ]
  • Rate of stroke at 30 days and 12 months. [ Time Frame: 30 days and 12 months ] [ Designated as safety issue: Yes ]
  • Ischemia-driven TLR and TVR at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Rate of stent thrombosis at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Any revascularization at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Rate of emergency or urgent revascularization through day 30. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Procedure success defined as lesion success without the occurrence of in-hospital MACE. [ Designated as safety issue: Yes ]
  • Major vascular complications including access site complications and major bleeding events requiring transfusion at 30 days. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Completeness of revascularization defined as proportion of epicardial vessels with >70% and <100% stenosis treated with procedural success (assessed in an angiographic subset of patients). [ Designated as safety issue: No ]
  • Appropriateness of revascularization defined as the proportion of lesions meeting ACC Class I and II guidelines (assessed in an angiographic subset of patients). [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Percutaneous Coronary Intervention (PCI) Outcomes in Community Versus Tertiary Settings
A Randomized Trial to Compare Percutaneous Coronary Intervention Between Massachusetts Hospitals With Cardiac Surgery-On-Site and Community Hospitals Without Cardiac Surgery-On-Site

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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Coronary Artery Diseases
Procedure: PCI
  • Active Comparator: SOS
    Patients randomized to the SOS arm are transferred to tertiary hospitals for their PCI procedure.
    Intervention: Procedure: PCI
  • Experimental: Non-SOS
    Patients in the non-SOS arm are randomized to stay at the community hospitals for their PCI procedure.
    Intervention: Procedure: PCI

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3691
December 2012
June 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01116882
DPH00
Yes
Alice Jacobs, MD, Boston University Medical Center
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
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
Harvard Clinical Research Institute
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP