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Trial record 62 of 95 for:    gadobenate dimeglumine

Stress Cardiac MRI for Evaluation of Nonspecific Allograft Dysfunction

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ClinicalTrials.gov Identifier: NCT02597543
Recruitment Status : Completed
First Posted : November 5, 2015
Results First Posted : August 22, 2017
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Paul Kim, Stanford University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Diagnostic
Conditions Heart Transplant
Acute Graft Rejection
Chronic Graft Rejection
Interventions Drug: Regadenoson
Drug: Gadolinium
Procedure: Cardiac MRI
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nonspecific Allograft Dysfunction Normal Graft Function
Hide Arm/Group Description

Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.

Regadenoson: For use in stress myocardial perfusion imaging.

Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.

Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.

Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.

Regadenoson: For use in stress myocardial perfusion imaging.

Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.

Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.

Period Title: Overall Study
Started 6 8
Completed 6 8
Not Completed 0 0
Arm/Group Title Nonspecific Allograft Dysfunction Normal Graft Function Total
Hide Arm/Group Description

Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.

Regadenoson: For use in stress myocardial perfusion imaging.

Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.

Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.

Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.

Regadenoson: For use in stress myocardial perfusion imaging.

Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.

Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.

Total of all reporting groups
Overall Number of Baseline Participants 6 8 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  66.7%
5
  62.5%
9
  64.3%
>=65 years
2
  33.3%
3
  37.5%
5
  35.7%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 6 participants 8 participants 14 participants
61.5
(48 to 70.5)
66
(52 to 68.5)
64
(48 to 70.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 14 participants
Female
0
   0.0%
3
  37.5%
3
  21.4%
Male
6
 100.0%
5
  62.5%
11
  78.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 14 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  16.7%
1
  12.5%
2
  14.3%
White
4
  66.7%
5
  62.5%
9
  64.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  16.7%
2
  25.0%
3
  21.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 6 participants 8 participants 14 participants
6
 100.0%
8
 100.0%
14
 100.0%
1.Primary Outcome
Title Myocardial Perfusion Reserve
Hide Description Myocardial perfusion reserve calculates the increase in myocardial perfusion after stress in comparison to rest. Outcome measure time frame specifies when the myocardial perfusion reserve was obtained in relation to date of heart-transplant for each patient. This was a one time measurement made after heart-transplantation.
Time Frame Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nonspecific Allograft Dysfunction Normal Graft Function
Hide Arm/Group Description:

Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.

Regadenoson: For use in stress myocardial perfusion imaging.

Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.

Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.

Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.

Regadenoson: For use in stress myocardial perfusion imaging.

Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.

Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.

Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: arbitrary units
1.52  (0.52) 1.94  (0.37)
2.Secondary Outcome
Title Myocardial Ischemia/Infarction
Hide Description Myocardial ischemia or infarct occurring from time of enrollment (when cardiac MRI performed) over subsequent 10 month period.
Time Frame 10 months after enrollment (when cardiac MRI was performed)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nonspecific Allograft Dysfunction Normal Graft Function
Hide Arm/Group Description:

Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.

Regadenoson: For use in stress myocardial perfusion imaging.

Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.

Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.

Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.

Regadenoson: For use in stress myocardial perfusion imaging.

Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.

Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.

Overall Number of Participants Analyzed 6 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Hospitalization for Cardiac Related Causes
Hide Description Hospitalization for cardiac related causes after enrollment. Time frame after enrollment (date of cardiac MRI) was 10 months
Time Frame 10 months after enrollment (from date of cardiac MRI)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nonspecific Allograft Dysfunction Normal Graft Function
Hide Arm/Group Description:

Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.

Regadenoson: For use in stress myocardial perfusion imaging.

Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.

Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.

Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.

Regadenoson: For use in stress myocardial perfusion imaging.

Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.

Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.

Overall Number of Participants Analyzed 6 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Re-transplantation
Hide Description Re-transplantation of the heart after enrollment (date of cardiac MRI). Measured 10 months after enrollment.
Time Frame 10 months after enrollment (from date of cardiac MRI)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nonspecific Allograft Dysfunction Normal Graft Function
Hide Arm/Group Description:

Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.

Regadenoson: For use in stress myocardial perfusion imaging.

Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.

Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.

Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.

Regadenoson: For use in stress myocardial perfusion imaging.

Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.

Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.

Overall Number of Participants Analyzed 6 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Late Gadolinium Enhancement
Hide Description Late gadolinium enhancement demonstrates myocardial scar by cardiac MRI. This is measured the day of the cardiac MRI scan and is a one time measurement. Time frame is measurement of late gadolinium enhancement from date of heart-transplantation.
Time Frame Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nonspecific Allograft Dysfunction Normal Graft Function
Hide Arm/Group Description:

Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.

Regadenoson: For use in stress myocardial perfusion imaging.

Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.

Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.

Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.

Regadenoson: For use in stress myocardial perfusion imaging.

Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.

Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.

Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: percentage of myocardium
5.7  (2.6) 1.8  (0.8)
6.Secondary Outcome
Title Mean Segmental T1 Values of the Left Ventricle
Hide Description T1 values are obtained at the time of the cardiac MRI and indicate the amount of myocardial edema. This was a one time measurement. Outcome measure time frame indicates when T1 values of the left ventricle were obtained in relation to heart-transplantation.
Time Frame Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nonspecific Allograft Dysfunction Normal Graft Function
Hide Arm/Group Description:

Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.

Regadenoson: For use in stress myocardial perfusion imaging.

Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.

Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.

Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.

Regadenoson: For use in stress myocardial perfusion imaging.

Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.

Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.

Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: Percentage of myocardium
44.5  (6.3) 38.1  (5.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nonspecific Allograft Dysfunction Normal Graft Function
Hide Arm/Group Description

Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.

Regadenoson: For use in stress myocardial perfusion imaging.

Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.

Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.

Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.

Regadenoson: For use in stress myocardial perfusion imaging.

Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.

Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.

All-Cause Mortality
Nonspecific Allograft Dysfunction Normal Graft Function
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Nonspecific Allograft Dysfunction Normal Graft Function
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nonspecific Allograft Dysfunction Normal Graft Function
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/8 (0.00%) 
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: Paul Kim, MD
Organization: UCSD
Phone: 3104907217
Publications:
Costanzo MR, Dipchand A, Starling R, Anderson A, Chan M, Desai S, Fedson S, Fisher P, Gonzales-Stawinski G, Martinelli L, McGiffin D, Smith J, Taylor D, Meiser B, Webber S, Baran D, Carboni M, Dengler T, Feldman D, Frigerio M, Kfoury A, Kim D, Kobashigawa J, Shullo M, Stehlik J, Teuteberg J, Uber P, Zuckermann A, Hunt S, Burch M, Bhat G, Canter C, Chinnock R, Crespo-Leiro M, Delgado R, Dobbels F, Grady K, Kao W, Lamour J, Parry G, Patel J, Pini D, Towbin J, Wolfel G, Delgado D, Eisen H, Goldberg L, Hosenpud J, Johnson M, Keogh A, Lewis C, O'Connell J, Rogers J, Ross H, Russell S, Vanhaecke J; International Society of Heart and Lung Transplantation Guidelines. The International Society of Heart and Lung Transplantation Guidelines for the care of heart transplant recipients. J Heart Lung Transplant. 2010 Aug;29(8):914-56. doi: 10.1016/j.healun.2010.05.034.
Responsible Party: Paul Kim, Stanford University
ClinicalTrials.gov Identifier: NCT02597543     History of Changes
Other Study ID Numbers: 1186278
First Submitted: October 30, 2015
First Posted: November 5, 2015
Results First Submitted: June 6, 2017
Results First Posted: August 22, 2017
Last Update Posted: August 22, 2017