Trial Outcomes & Findings for Stress Cardiac MRI for Evaluation of Nonspecific Allograft Dysfunction (NCT NCT02597543)
NCT ID: NCT02597543
Last Updated: 2017-08-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
14 participants
Primary outcome timeframe
Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation.
Results posted on
2017-08-22
Participant Flow
Participant milestones
| Measure |
Nonspecific Allograft Dysfunction
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.
|
Normal Graft Function
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 Study
STARTED
|
6
|
8
|
|
Overall Study
COMPLETED
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stress Cardiac MRI for Evaluation of Nonspecific Allograft Dysfunction
Baseline characteristics by cohort
| Measure |
Nonspecific Allograft Dysfunction
n=6 Participants
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.
|
Normal Graft Function
n=8 Participants
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
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
61.5 years
n=5 Participants
|
66 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation.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.
Outcome measures
| Measure |
Nonspecific Allograft Dysfunction
n=6 Participants
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.
|
Normal Graft Function
n=8 Participants
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.
|
|---|---|---|
|
Myocardial Perfusion Reserve
|
1.52 arbitrary units
Standard Deviation 0.52
|
1.94 arbitrary units
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: 10 months after enrollment (when cardiac MRI was performed)Myocardial ischemia or infarct occurring from time of enrollment (when cardiac MRI performed) over subsequent 10 month period.
Outcome measures
| Measure |
Nonspecific Allograft Dysfunction
n=6 Participants
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.
|
Normal Graft Function
n=8 Participants
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.
|
|---|---|---|
|
Myocardial Ischemia/Infarction
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 10 months after enrollment (from date of cardiac MRI)Hospitalization for cardiac related causes after enrollment. Time frame after enrollment (date of cardiac MRI) was 10 months
Outcome measures
| Measure |
Nonspecific Allograft Dysfunction
n=6 Participants
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.
|
Normal Graft Function
n=8 Participants
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.
|
|---|---|---|
|
Hospitalization for Cardiac Related Causes
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 10 months after enrollment (from date of cardiac MRI)Re-transplantation of the heart after enrollment (date of cardiac MRI). Measured 10 months after enrollment.
Outcome measures
| Measure |
Nonspecific Allograft Dysfunction
n=6 Participants
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.
|
Normal Graft Function
n=8 Participants
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.
|
|---|---|---|
|
Re-transplantation
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation.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.
Outcome measures
| Measure |
Nonspecific Allograft Dysfunction
n=6 Participants
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.
|
Normal Graft Function
n=8 Participants
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.
|
|---|---|---|
|
Late Gadolinium Enhancement
|
5.7 percentage of myocardium
Standard Deviation 2.6
|
1.8 percentage of myocardium
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation.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.
Outcome measures
| Measure |
Nonspecific Allograft Dysfunction
n=6 Participants
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.
|
Normal Graft Function
n=8 Participants
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.
|
|---|---|---|
|
Mean Segmental T1 Values of the Left Ventricle
|
44.5 Percentage of myocardium
Standard Deviation 6.3
|
38.1 Percentage of myocardium
Standard Deviation 5.9
|
Adverse Events
Nonspecific Allograft Dysfunction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Graft Function
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place