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
Results First Received: June 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Coronary Artery Diseases
Intervention: Procedure: PCI

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PCI at a Hospital Without On-site Cardiac Surgery Assigned to PCI at a hospital without on-site cardiac surgery
PCI at Hospital With On-Site Cardiac Surgery Assigned to PCI at a hospital with on-site cardiac surgery

Participant Flow for 2 periods

Period 1:   30-day
    PCI at a Hospital Without On-site Cardiac Surgery     PCI at Hospital With On-Site Cardiac Surgery  
STARTED     2774     917  
COMPLETED     2706     886  
NOT COMPLETED     68     31  
Lost to Follow-up                 50                 21  
Withdrawal by Subject                 2                 4  
Other Reasons                 16                 6  

Period 2:   12-month
    PCI at a Hospital Without On-site Cardiac Surgery     PCI at Hospital With On-Site Cardiac Surgery  
STARTED     2706     886  
COMPLETED     2439     787  
NOT COMPLETED     267     99  
Lost to Follow-up                 111                 42  
Other Reasons                 151                 49  
Withdrawal by Subject                 5                 8  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PCI at Hospitals Without On-Site Cardiac Surgery Assigned to PCI at a hospital without on-site cardiac surgery
PCI at Hospital With On-Site Cardiac Surgery Assigned to PCI at a hospital with on-site cardiac surgery
Total Total of all reporting groups

Baseline Measures
    PCI at Hospitals Without On-Site Cardiac Surgery     PCI at Hospital With On-Site Cardiac Surgery     Total  
Number of Participants  
[units: participants]
  2774     917     3691  
Age  
[units: years]
Mean ± Standard Deviation
  64.71  ± 11.84     64.16  ± 11.81     64.57  ± 11.83  
Gender, Customized  
[units: participants]
     
Female     883     308     1191  
Race/Ethnicity, Customized  
[units: participants]
     
White     2526     852     3378  
Black     51     9     60  
Hispanic     117     35     152  
Other     80     21     101  



  Outcome Measures
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1.  Primary:   30-day Composite Major Adverse Cardiac Event (MACE)   [ Time Frame: 30 days ]

2.  Primary:   12-month Composite Major Adverse Cardiac Event (MACE)   [ Time Frame: 12 month ]

3.  Secondary:   All Cause Mortality at 30 Days   [ Time Frame: 30 days ]

4.  Secondary:   Ischemia-driven Target Lesion Revascularization   [ Time Frame: 30 days ]

5.  Secondary:   Ischemia-driven Target Lesion Revascularization   [ Time Frame: 12 months ]

6.  Secondary:   Rate of Stent Thrombosis   [ Time Frame: 12 months ]

7.  Secondary:   Any Repeat Revascularization   [ Time Frame: 12 months ]

8.  Secondary:   Emergency or Urgent Revascularization   [ Time Frame: 30 days ]

9.  Secondary:   Procedural Success   [ Time Frame: Discharge ]

10.  Secondary:   Major Vascular Complications   [ Time Frame: 30 days ]

11.  Secondary:   Complete Revascularization   [ Time Frame: discharge ]

12.  Secondary:   Met Indication Criteria for PCI   [ Time Frame: discharge ]

13.  Secondary:   All Cause Mortality at 12 Months   [ Time Frame: 12 months ]

14.  Secondary:   Ischemia-driven Target Vessel Revascularization   [ Time Frame: 30 days ]

15.  Secondary:   Ischemia-driven Target Vessel Revascularization   [ Time Frame: 12 months ]

16.  Secondary:   Rate of Stent Thrombosis   [ Time Frame: 30 days ]

17.  Secondary:   Any Repeat Revascularization   [ Time Frame: 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Not applicable


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Katherine Agule
Organization: Harvard Clinical Research Institute
phone: 617-307-5200
e-mail: kagule@hcri.harvard.edu


No publications provided by Harvard Clinical Research Institute

Publications automatically indexed to this study:

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