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Coronary Artery DiseaseNCT02072421

The MASS COMM Post-Randomization Phase Cohort Study

A study testing PCI in people with Coronary Artery Disease, run by Baim Institute for Clinical Research at 10 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 Post-Randomization Phase Cohort Study is to continue to assess the safety of non-emergency PCI performed at hospitals without cardiac surgery on-site in patients with myocardial ischemia (other than ST-segment elevation myocardial infarction [STEMI]). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
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
2,879 participants
Where
10 sitesUnited States
Study dates
Oct 2011to Oct 2013
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

  • Candidates for this study must meet ALL of the following 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). N.B. staged procedure will not be considered to meet the endpoint component of repeat revascularization if either of the following pre-catheterization procedure qualifying clinical laboratory values are met:
  • eGFR is less than 60 ml/min or
  • creatinine is greater than 1.5 mg/dl
  • Subject's lesion(s) is (are) amenable to stent treatment with currently available FDA-approved bare metal or drug eluting stents.
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  • Subject is an acceptable candidate for non-emergency, urgent or emergency 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 and the treating physician agree that the subject will comply with all follow-up evaluations.
  • Subject has been informed of the nature and purpose 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.
  • Angiographic Inclusion Criteria
  • The target lesion(s) is (are) de novo or restenotic (including in-stent restenotic) native coronary artery lesion(s) with greater or equal to 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.
  • If Fractional Flow Reserve (FFR) is measured, target lesion(s) has (have) evidence of a hemodynamically significant stenosis determined by FFR measurement (FFR less than or equal to 0.8).
  • 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) greater than 72 hours following the STEMI.
  • Lesions treated with PCI greater 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

  • Subjects will be excluded from participation in the Cohort Study (and non-emergency PCI may not be performed in these patients at the non-SOS site) if ANY of the following conditions apply:
  • The patient is pregnant or breastfeeding.
  • Evidence of ST segment elevation myocardial infarction 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), prasugrel (Effient), and ticlopidine (Ticlid), heparin, bivalirudin, stainless steel, or contrast agent (which cannot be adequately premedicated).
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  • 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 less 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 the MASS-COMM Trial, unless the patient has completed the 12-month follow-up for the Trial, and/or prior participation in the Cohort Study, unless the patient has completed the 30-day follow-up for the Cohort Study.
  • Within 30 days prior to the index Cohort 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 GI bleeding within the prior 3 months.
  • Subject has active sepsis.
  • Unprotected left main coronary artery disease (stenosis greater than 50%).
  • Subject has evidence of a hemodynamically insignificant stenosis determined by FFR measurement (FFR greater than 0.8).
  • In the investigator's opinion, subject has a co-morbid condition(s) that could limit the subject's ability to participate in the study or comply with follow-up requirements or impact the scientific integrity of the study.
  • Angiographic Exclusion Criteria
  • 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)
  • tortuosity (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 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., >2 non-target epicardial vessels and the bypass grafts to these territories [if present] are totally occluded).

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Good Samaritan Medical Center

    Brockton, Massachusetts, 02301

  • Brockton Hospital

    Brockton, Massachusetts, 02302

  • Metrowest Medical Center

    Framingham, Massachusetts, 01702

  • Lawrence General Hospital

    Lawrence, Massachusetts, 01842

  • Saints Memorial Medical Center

    Lowell, Massachusetts, 01824

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • Melrose-Wakefield Hospital

    Melrose, Massachusetts, 02176

  • Holy Family Hospital

    Methuen, Massachusetts, 01844

  • Norwood Hospital

    Norwood, Massachusetts, 02062

  • South Shore Hospital

    Weymouth, Massachusetts, 02190

Other trials in United States

About this study

Official title: A Prospective, Multi-center, Non-Randomized, Single-arm, Open-label Study of Percutaneous Coronary Intervention in Community Hospitals Without Cardiac Surgery-On-Site

The primary objective of the Post-Randomization Phase Cohort Study is to continue to assess the safety of non-emergency PCI performed at hospitals without cardiac surgery on-site in patients with myocardial ischemia (other than ST-segment elevation myocardial infarction [STEMI]).

Read the detailed description

The MASS COMM Post-Randomization Phase Cohort Study ("Cohort Study" is a prospective, multi-center, single-arm study of non-emergency PCI performed at non-SOS hospitals in patients with myocardial ischemia (other than STEMI). The Cohort Study is designed to allow non-SOS hospitals to continue to perform non-emergency PCI after enrollment to the MASS COMM trial is completed and before the 30-day and 12-month results are available.

Specifically, all eligible subjects, after enrollment to the MASS COMM randomized controlled trial is completed and before the final results are available and a decision is reached by the MA-DPH, will be consented and enrolled into this Cohort Study. Subjects will be followed through 30 days post procedure.

Being tested
PCI
Medical subject headings
Coronary Artery Disease

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 NCT02072421
Study groupRoleWhat they receive
Non-SOSOtherNot described
Receives: Procedure: PCI

What is being measured

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

  1. Major Adverse Cardiac Event (MACE)

    MACE is a composite of all cause mortality, myocardial infarction (Q wave and non-Q wave), repeat coronary revascularization (of the target vessel or non-target vessel) by either percutaneous or coronary artery bypass graft (CABG) methods, or stroke, at 30-days.

    Measured: 30-days

Secondary outcomes (4)

  1. All-Cause Mortality

    all-cause mortality through 30 days post-procedure

    Measured: 30 days

  2. Stroke

    Stroke through 30 days post-procedure

    Measured: 30 days

  3. Revascularization

    Repeat coronary revascularization including emergency or urgent revascularization through 30 days post-procedure

    Measured: 30 days

  4. Major Vascular Complications

    Major vascular complications, including access site complications and major bleeding events requiring transfusion,through 30 days post-procedure.

    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 posted26 Feb 2014 (estimated)
  2. Study startOct 2011
  3. Primary completionSep 2013
  4. Study completionOct 2013

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,879 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02072421
Sponsor's protocol ID
DPH00-Cohort
Status last verified
Mar 2015
First submitted
24 Feb 2014
Last updated
7 Apr 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing PCI in people with Coronary Artery Disease, run by Baim Institute for Clinical Research at 10 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 16 inclusion and 26 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 10 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?

Major Adverse Cardiac Event (MACE) (time frame: 30-days). 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 NCT02072421.

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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