The MASS COMM Post-Randomization Phase Cohort Study

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 (Responsible Party):
Harvard Clinical Research Institute
ClinicalTrials.gov Identifier:
NCT02072421
First received: February 24, 2014
Last updated: June 6, 2014
Last verified: June 2014
Results First Received: June 6, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Coronary Artery Disease
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
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Reporting Groups
  Description
PCI at Hospitals Without On-Site Cardiac Surgery PCI at a hospital without on-site cardiac surgery

Participant Flow:   Overall Study
    PCI at Hospitals Without On-Site Cardiac Surgery  
STARTED     2879  
COMPLETED     2489  
NOT COMPLETED     390  



  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 PCI at a hospital without on-site cardiac surgery

Baseline Measures
    PCI at Hospitals Without On-Site Cardiac Surgery  
Number of Participants  
[units: participants]
  2879  
Age  
[units: years]
Mean ± Standard Deviation
  64.92  ± 11.48  
Gender, Customized  
[units: participants]
 
Male     1955  
Race/Ethnicity, Customized  
[units: participants]
 
Caucasian     2595  
Black     61  
Hispanic     153  
Asian     50  
Native American     1  
Other     19  



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

2.  Secondary:   All-Cause Mortality   [ Time Frame: 30 days ]

3.  Secondary:   Stroke   [ Time Frame: 30 days ]

4.  Secondary:   Revascularization   [ Time Frame: 30 days ]

5.  Secondary:   Major Vascular Complications   [ 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


Responsible Party: Harvard Clinical Research Institute
ClinicalTrials.gov Identifier: NCT02072421     History of Changes
Other Study ID Numbers: DPH00-Cohort
Study First Received: February 24, 2014
Results First Received: June 6, 2014
Last Updated: June 6, 2014
Health Authority: United States: n/a