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Comprehensive Cardiothoracic Dual Source CT for the Early Triage of Patients With Acute Chest Pain (CAPTURE)

This study has been completed.
Sponsor:
Collaborator:
Bracco Diagnostics, Inc
Information provided by (Responsible Party):
Udo Hoffmann, MD MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01067456
First received: February 10, 2010
Last updated: October 14, 2014
Last verified: October 2014
Results First Received: April 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Chest Pain Syndrome
Intervention: Radiation: Comprehensive Cardiothoracic CT arm

  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
Emergency Department, 9-month enrollment period starting January 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None

Reporting Groups
  Description
Dedicated CT Arm Subjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
Comprehensive Cardiothoracic CT Arm Subjects in this arm receive a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.

Participant Flow:   Overall Study
    Dedicated CT Arm     Comprehensive Cardiothoracic CT Arm  
STARTED     30     29  
COMPLETED     30     29  
NOT COMPLETED     0     0  



  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
Dedicated CT Arm Subjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
Comprehensive Cardiothoracic CT Arm

Subjects in this arm receive a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.

Comprehensive Cardiothoracic Dual Source CT (DSCT) arm: Subjects in this arm will receive the comprehensive cardiothoracic DSCT to rule out aortic dissection/pulmonary embolism/acute coronary syndrome in a single scan.

Total Total of all reporting groups

Baseline Measures
    Dedicated CT Arm     Comprehensive Cardiothoracic CT Arm     Total  
Number of Participants  
[units: participants]
  30     29     59  
Age  
[units: years]
Mean ± Standard Deviation
  50  ± 12     53  ± 11     51  ± 11  
Gender  
[units: participants]
     
Female     10     6     16  
Male     20     23     43  
Region of Enrollment  
[units: participants]
     
United States     30     29     59  



  Outcome Measures

1.  Primary:   Length of Hospital Stay   [ Time Frame: up to 1 week ]

2.  Secondary:   To Compare the Cost of Care Between the Comprehensive Cardiothoracic CT Arm and the Dedicated Aortic Dissection/Acute Coronary Syndrome/Pulmonary Embolism CT Protocol (Standard of Care) Arm   [ Time Frame: Index Hospitalization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  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: Dr. Udo Hoffmann
Organization: MGH
phone: 617-726-1255
e-mail: uhoffmann@partners.org


No publications provided


Responsible Party: Udo Hoffmann, MD MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01067456     History of Changes
Other Study ID Numbers: 2008P000389
Study First Received: February 10, 2010
Results First Received: April 8, 2014
Last Updated: October 14, 2014
Health Authority: United States: Institutional Review Board