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

Hybrid Revascularization Observational Study

This study has been completed.
Sponsor:
Collaborators:
International Center for Health Outcomes and Innovation Research
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT01121263
First received: May 10, 2010
Last updated: February 7, 2014
Last verified: February 2014
Results First Received: November 25, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Coronary Artery Disease

  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
Study Recruitment started in May 2010 and completed in November 2011 across 11 US medical centers that included adult patients with multivessel coronary artery disease and clinical indication for revascularization, who were candidates for both Hybrid Coronary Revascularization (HCR) and Percutaneous Coronary Intervention (PCI) with DES

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
Cohort 2: Intervention Cohort - HCR Group (N=200) Patients who underwent Hybrid Coronary Revascularization (HCR) with minimally invasive LIMA-LAD CABG
Cohort 2: Intervention Cohort - PCI Group (N=98) Patients who met proposed anatomic and clinical eligibility criteria and underwent multivessel Percutaneous Coronary Intervention (PCI) with drug eluting stents (DES)

Participant Flow:   Overall Study
    Cohort 2: Intervention Cohort - HCR Group (N=200)   Cohort 2: Intervention Cohort - PCI Group (N=98)
STARTED   200   98 
COMPLETED   175   83 
NOT COMPLETED   25   15 
Death                3                2 
Lost to Follow-up                22                12 
Withdrawal by Subject                0                1 



  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
Cohort 2: Intervention Cohort - HCR Group (N=200) Patients who underwent Hybrid Coronary Revascularization (HCR) with minimally invasive LIMA-LAD CABG
Cohort 2: Intervention Cohort - PCI Group (N=98) Patients who met proposed anatomic and clinical eligibility criteria and underwent multivessel Percutaneous Coronary Intervention (PCI) with drug eluting stents (DES)
Total Total of all reporting groups

Baseline Measures
   Cohort 2: Intervention Cohort - HCR Group (N=200)   Cohort 2: Intervention Cohort - PCI Group (N=98)   Total 
Overall Participants Analyzed 
[Units: Participants]
 200   98   298 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Age   64.41  (11.78)   63.91  (10.82)   64.24  (11.46) 
Gender 
[Units: Participants]
     
Female   48   28   76 
Male   152   70   222 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   10   9   19 
Not Hispanic or Latino   183   83   266 
Unknown or Not Reported   7   6   13 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   4   3   7 
Native Hawaiian or Other Pacific Islander   1   0   1 
Black or African American   28   11   39 
White   161   83   244 
More than one race   0   0   0 
Unknown or Not Reported   6   1   7 
Region of Enrollment 
[Units: Participants]
     
United States   200   98   298 


  Outcome Measures
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1.  Primary:   Major Adverse Cardiac and Cerebrovascular Event (MACCE)   [ Time Frame: Month 12 ]

2.  Secondary:   Major Adverse Cardiac and Cerebrovascular Event (MACCE)   [ Time Frame: Occurence of MACCE through the end of study up to two years ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Deborah Ascheim, MD
Organization: Icahn School of Medicine at Mount Sinai
phone: 212-659-9567
e-mail: deborah.ascheim@mssm.edu



Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01121263     History of Changes
Other Study ID Numbers: GCO 09-0657
1RC1HL100951 ( US NIH Grant/Contract Award Number )
Study First Received: May 10, 2010
Results First Received: November 25, 2013
Last Updated: February 7, 2014
Health Authority: United States: Institutional Review Board