Trial Outcomes & Findings for Quantification of Intramyocardial Lipid by Proton Magnetic Resonance Spectroscopy (NCT NCT00469911)
NCT ID: NCT00469911
Last Updated: 2018-09-13
Results Overview
Participants first had MRS spectroscopy then the MRS spectroscopy images were compared to endomyocardial biopsy
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
2 to 10 days
Results posted on
2018-09-13
Participant Flow
Participant milestones
| Measure |
Heart Transplant
Compare Magnetic resonance myocardial lipid measurements with biopsy derived ex vivo measurements
Magnetic Resonance Spectroscopy: It is basically the same as an MRI. It is a noninvasive procedure that provides detailed body images on any plane.
Endocardial Biopsy: This is a standard of care procedure that is already performed on heart transplant patients. This is a procedure that takes a biopsy (tissue sample) of the heart muscle.
|
Controls
Normal volunteers used to assess reproducability of the MRS measurements
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
|
Overall Study
COMPLETED
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Quantification of Intramyocardial Lipid by Proton Magnetic Resonance Spectroscopy
Baseline characteristics by cohort
| Measure |
Heart Transplant
n=8 Participants
Compare Magnetic resonance myocardial lipid measurements with biopsy derived ex vivo measurements
Magnetic Resonance Spectroscopy: It is a noninvasive procedure that provides detailed body images on any plane.
Endocardial Biopsy: This is a standard of care procedure that is already performed on heart transplant patients. This is a procedure that takes a biopsy (tissue sample) of the heart muscle.
|
Control Subjects
n=10 Participants
Control subjects with a broad range of body mass indexes and physiological conditions.
|
Total
n=18 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
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 to 10 daysParticipants first had MRS spectroscopy then the MRS spectroscopy images were compared to endomyocardial biopsy
Outcome measures
| Measure |
Heart Transplant Patients
n=8 Participants
Measurement of triglycerides in heart transplant patients using MRI
|
|---|---|
|
Correlation Co-efficient Between MRS Spectroscopy and Endomyocardial Biopsy in Heart Transplant Participants
|
0.97 correlation co-efficient
|
Adverse Events
Heart Transplant - Endomyocardial Biopsy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Subjects
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
Robert Gropler, MD, Chief of Cardiovascular Imaging Laboratory
Washington University School of Medicine
Phone: 314-747-0183
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place