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The MASS COMM Post-Randomization Phase Cohort Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02072421
Recruitment Status : Completed
First Posted : February 26, 2014
Results First Posted : July 8, 2014
Last Update Posted : April 7, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition: Coronary Artery Disease
Intervention: Procedure: PCI

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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

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.
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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 
Overall Participants Analyzed 
[Units: Participants]
 2879 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.92  (11.48) 
Gender, Customized 
[Units: Participants]
 
Male   1955 
Female   924 
Race/Ethnicity, Customized 
[Units: Participants]
 
Caucasian   2595 
Black   61 
Hispanic   153 
Asian   50 
Native American   1 
Other   19 


  Outcome Measures

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

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
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  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



Responsible Party: Baim Institute for Clinical Research
ClinicalTrials.gov Identifier: NCT02072421     History of Changes
Other Study ID Numbers: DPH00-Cohort
First Submitted: February 24, 2014
First Posted: February 26, 2014
Results First Submitted: June 6, 2014
Results First Posted: July 8, 2014
Last Update Posted: April 7, 2015