Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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, Methuen, MA
Lawrence General Hospital
Lowell General Hospital
Melrose Wakefield Hospital
Metro West Medical Center
Saints Memorial Medical Center
South Shore Hospital
Information provided by (Responsible Party):
Harvard Clinical Research Institute
ClinicalTrials.gov Identifier:
NCT01116882
First received: April 29, 2010
Last updated: March 18, 2015
Last verified: March 2015
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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 
Male   1891   609   2500 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   2526   852   3378 
Black   51   9   60 
Hispanic   117   35   152 
Other   80   21   101 


  Outcome Measures
  Show All Outcome Measures

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: Post-Procedure ]

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

11.  Secondary:   Complete Revascularization   [ Time Frame: Post-Procedure ]

12.  Secondary:   Met Indication Criteria for PCI   [ Time Frame: Post-Procedure ]

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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: Priscilla Driscoll-Shemp
Organization: Harvard Clinical Research Institute
phone: 617-307-5200
e-mail: priscilla.driscoll-shempp@hcri.harvard.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Harvard Clinical Research Institute
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: March 18, 2015
Health Authority: United States: Institutional Review Board