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Coronary Artery DiseasesMASS COMMNCT01116882

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

A study testing PCI in people with Coronary Artery Diseases, run by Baim Institute for Clinical Research at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Diseases
What is being tested?
PCI
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,691 participants
Where
17 sitesUnited States
Study dates
Jun 2006to Dec 2012
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).
  • 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).

Who cannot join

  • 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.
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  • 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.
  • 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).
  • 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.
  • 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.).
  • Any lesion that is located in a saphenous vein graft, however, lesions located within the native vessel but accessed through the graft are eligible.
  • 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).

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Tufts New England Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02120

  • Beth Israel Deaconnes Medical Center

    Boston, Massachusetts, 02215

  • Caritas St. Elizabeth's Hospital

    Brighton, Massachusetts, 02135

  • Brockton Hospital

    Brockton, Massachusetts, 02301

  • Caritas Good Samaritan Medical Center

    Brockton, Massachusetts, 02301

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • Metrowest Medical Center

    Framingham, Massachusetts, 01702

  • Lawrence General Hospital

    Haverhill, Massachusetts, 01803

  • Saints Memorial Medical Center

    Lowell, Massachusetts, 01853

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • Melrose Wakefield Hospital

    Melrose, Massachusetts, 02176

  • Caritas Holy Family Hospital

    Methuen, Massachusetts, 01844

  • Caritas Norwood Hospital

    Norwood, Massachusetts, 02062

  • South Shore Hospital

    Weymouth, Massachusetts, 02190

Other trials in United States

About this study

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

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.

Read the 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).

Being tested
PCI
Keywords
PCI, heart disease, ischemic heart disease
Medical subject headings
Coronary Artery Disease, Heart Diseases, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCIProcedure or surgery

Study groups in NCT01116882
Study groupRoleWhat they receive
SOSActive comparatorPatients randomized to the SOS arm are transferred to tertiary hospitals for their PCI procedure.
Receives: Procedure: PCI
Non-SOSExperimentalPatients in the non-SOS arm are randomized to stay at the community hospitals for their PCI procedure.
Receives: Procedure: PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30-day Composite Major Adverse Cardiac Event (MACE)

    Measured: 30 days

  2. 12-month Composite Major Adverse Cardiac Event (MACE)

    Measured: 12 month

Secondary outcomes (15)

  1. All Cause Mortality at 30 Days

    Measured: 30 days

  2. Ischemia-driven Target Lesion Revascularization

    Measured: 30 days

  3. Ischemia-driven Target Lesion Revascularization

    Measured: 12 months

  4. Rate of Stent Thrombosis

    Measured: 12 months

  5. Any Repeat Revascularization

    Measured: 12 months

  6. Emergency or Urgent Revascularization

    Measured: 30 days

  7. Procedural Success

    Procedural success is defined as residual stenosis of the target lesion of less than 20%

    Measured: Post-Procedure

  8. Major Vascular Complications

    Measured: 30 days

  9. Complete Revascularization

    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.

    Measured: Post-Procedure

  10. Met Indication Criteria for PCI

    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.

    Measured: Post-Procedure

  11. All Cause Mortality at 12 Months

    Measured: 12 months

  12. Ischemia-driven Target Vessel Revascularization

    Measured: 30 days

  13. Ischemia-driven Target Vessel Revascularization

    Measured: 12 months

  14. Rate of Stent Thrombosis

    Measured: 30 days

  15. Any Repeat Revascularization

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2010 (estimated)
  2. Study startJun 2006
  3. Primary completionJun 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,691 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01116882
Sponsor's protocol ID
DPH00
Acronym
MASS COMM
Status last verified
Mar 2015
First submitted
29 Apr 2010
Last updated
7 Apr 2015
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23477625

  • 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.

    PubMed 22093197

Questions about this trial

What is this clinical trial studying?

A study testing PCI in people with Coronary Artery Diseases, run by Baim Institute for Clinical Research at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30-day Composite Major Adverse Cardiac Event (MACE) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01116882, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.

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