The MASS COMM Post-Randomization Phase Cohort Study

NCT02072421 | Completed Results

• 1 other identifier: DPH00-Cohort
• Study Type: interventional
• Target: 2,879
• Locations: 1 country
• Sites: 10

Brief 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 \[STEMI\]).

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (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.

  30-days

Secondary Outcomes (4)

• All-Cause Mortality

  30 days

• Stroke

  30 days

• Revascularization

  30 days

• Major Vascular Complications

  30 days

Study Arms (1)

Non-SOS

OTHER

Procedure: PCI

Interventions

PCI PROCEDURE

Non-SOS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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).
• 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.
• 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).

Sponsors & Collaborators

• Baim Institute for Clinical Research: lead
• Brockton Hospital: collaborator
• Good Samaritan Hospital Medical Center, New York: collaborator
• Norwood Hospital: collaborator
• Holy Family Hospital, Methuen, MA: collaborator
• Lawrence General Hospital: collaborator
• Lowell General Hospital: collaborator
• Melrose Wakefield Hospital: collaborator
• Metro West Medical Center: collaborator
• Saints Memorial Medical Center: collaborator
• South Shore Hospital: collaborator

Study Sites (10)

Good Samaritan Medical Center

Brockton, Massachusetts, 02301, United States

Location

Brockton Hospital

Brockton, Massachusetts, 02302, United States

Location

Metrowest Medical Center

Framingham, Massachusetts, 01702, United States

Location

Lawrence General Hospital

Lawrence, Massachusetts, 01842, United States

Location

Saints Memorial Medical Center

Lowell, Massachusetts, 01824, United States

Location

Lowell General Hospital

Lowell, Massachusetts, 01854, United States

Location

Melrose-Wakefield Hospital

Melrose, Massachusetts, 02176, United States

Location

Holy Family Hospital

Methuen, Massachusetts, 01844, United States

Location

Norwood Hospital

Norwood, Massachusetts, 02062, United States

Location

South Shore Hospital

Weymouth, Massachusetts, 02190, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular 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

• Laura Mauri, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Sharon-Lise Normand, PhD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: February 26, 2014
• Study Start: October 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 7, 2015
• Results First Posted: July 8, 2014

Record last verified: 2015-03

Locations

US (10)