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Coronary Artery Vasculopathy in Pediatric Heart Transplant Patients (CFR-OHT)

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ClinicalTrials.gov Identifier: NCT03231371
Recruitment Status : Completed
First Posted : July 27, 2017
Results First Posted : September 26, 2017
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
Bryan Goldstein, University of Michigan

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Orthotopic Heart Transplant
Intervention: Drug: Adenosine

  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
Study Arm Adenosine: Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).

Participant Flow:   Overall Study
    Study Arm
STARTED   22 
Optional and Age Limited (12 Yrs+) MRI   9 
COMPLETED   9 
NOT COMPLETED   13 
Withdrawal by Subject                1 
chose or were ineligible to have MRI                12 



  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
Study Arm Adenosine: Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).

Baseline Measures
   Study Arm 
Overall Participants Analyzed 
[Units: Participants]
 22 
Age, Customized 
[Units: Participants]
Count of Participants
 
1-18 years   14 
18 - 25 years   8 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      10  45.5% 
Male      12  54.5% 
Region of Enrollment 
[Units: Participants]
 
United States   22 


  Outcome Measures

1.  Primary:   Coronary Flow Reserve (CFR)   [ Time Frame: Baseline testing (acute only), 3 minutes of adenosine infusion ]

2.  Secondary:   Gadolinium Enhancement by Cardiac MRI   [ Time Frame: Baseline MRI only ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Bryan Goldstein
Organization: University of Michigan
e-mail: Bryan.Goldstein@cchmc.org



Responsible Party: Bryan Goldstein, University of Michigan
ClinicalTrials.gov Identifier: NCT03231371     History of Changes
Other Study ID Numbers: HUM23585
First Submitted: October 19, 2011
First Posted: July 27, 2017
Results First Submitted: August 29, 2017
Results First Posted: September 26, 2017
Last Update Posted: September 26, 2017