Trial Outcomes & Findings for Myocardial Lipid and Creatine of Heart Failure on MRS (NCT NCT02378402)
NCT ID: NCT02378402
Last Updated: 2019-10-21
Results Overview
We quantified the total myocardial TG resonance as well as its components including FA (lipid resonances δ 0.9, 1.3 and 1.6 ppm) and UFA (lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) from water-suppressed spectra. We also determined the water resonance (\~ δ 4.7 ppm) from spectra without water suppression. Myocardial TG content relative to water as well as relative amounts of myocardial TG was calculated from the available data.
Recruitment status
COMPLETED
Target enrollment
71 participants
Primary outcome timeframe
12 month
Results posted on
2019-10-21
Participant Flow
Participant milestones
| Measure |
Unstable HF Group
Patients with acute HF episode with hospitalization treatment within 12 months, currently LVEF\<50%. Proton (1H-) magnetic resonance (MR) spectroscopy.
Proton (1H-) magnetic resonance (MR) spectroscopy: PRESS localized 1D MRS sequence was used on a 3-T MR system. The lipid resonances will be analyzed using the LC-Model algorithm, and a Cramer-Rao lower bound (CRLB) threshold of 50% was used as quality control. Resonances of fatty acid (FA, lipid resonances δ 0.9, 1.3 and 1.6 ppm) and polyunsaturated fatty acid (PUFA, lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) will be evaluated on MRS, with ratios normalized with total TG value.
|
Stable HF Group
Patients with acute HF episode with hospitalization treatment within 12 months, LVEF\>=50%. Proton (1H-) magnetic resonance (MR) spectroscopy.
Proton (1H-) magnetic resonance (MR) spectroscopy: PRESS localized 1D MRS sequence was used on a 3-T MR system. The lipid resonances will be analyzed using the LC-Model algorithm, and a Cramer-Rao lower bound (CRLB) threshold of 50% was used as quality control. Resonances of fatty acid (FA, lipid resonances δ 0.9, 1.3 and 1.6 ppm) and polyunsaturated fatty acid (PUFA, lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) will be evaluated on MRS, with ratios normalized with total TG value.
|
Control Group
Age- and gender-matched healthy volunteers recruited as normal control group. Proton (1H-) magnetic resonance (MR) spectroscopy.
Proton (1H-) magnetic resonance (MR) spectroscopy: PRESS localized 1D MRS sequence was used on a 3-T MR system. The lipid resonances will be analyzed using the LC-Model algorithm, and a Cramer-Rao lower bound (CRLB) threshold of 50% was used as quality control. Resonances of fatty acid (FA, lipid resonances δ 0.9, 1.3 and 1.6 ppm) and polyunsaturated fatty acid (PUFA, lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) will be evaluated on MRS, with ratios normalized with total TG value.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
21
|
|
Overall Study
COMPLETED
|
25
|
23
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Myocardial Lipid and Creatine of Heart Failure on MRS
Baseline characteristics by cohort
| Measure |
Unstable HF Group
n=25 Participants
Patients with acute HF episode with hospitalization treatment within 12 months, currently LVEF\<50%. Proton (1H-) magnetic resonance (MR) spectroscopy.
Proton (1H-) magnetic resonance (MR) spectroscopy: PRESS localized 1D MRS sequence was used on a 3-T MR system. The lipid resonances will be analyzed using the LC-Model algorithm, and a Cramer-Rao lower bound (CRLB) threshold of 50% was used as quality control. Resonances of fatty acid (FA, lipid resonances δ 0.9, 1.3 and 1.6 ppm) and polyunsaturated fatty acid (PUFA, lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) will be evaluated on MRS, with ratios normalized with total TG value.
|
Stable HF Group
n=23 Participants
Patients with acute HF episode with hospitalization treatment within 12 months, LVEF\>=50%. Proton (1H-) magnetic resonance (MR) spectroscopy.
Proton (1H-) magnetic resonance (MR) spectroscopy: PRESS localized 1D MRS sequence was used on a 3-T MR system. The lipid resonances will be analyzed using the LC-Model algorithm, and a Cramer-Rao lower bound (CRLB) threshold of 50% was used as quality control. Resonances of fatty acid (FA, lipid resonances δ 0.9, 1.3 and 1.6 ppm) and polyunsaturated fatty acid (PUFA, lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) will be evaluated on MRS, with ratios normalized with total TG value.
|
Control Group
n=21 Participants
Age- and gender-matched healthy volunteers recruited as normal control group. Proton (1H-) magnetic resonance (MR) spectroscopy.
Proton (1H-) magnetic resonance (MR) spectroscopy: PRESS localized 1D MRS sequence was used on a 3-T MR system. The lipid resonances will be analyzed using the LC-Model algorithm, and a Cramer-Rao lower bound (CRLB) threshold of 50% was used as quality control. Resonances of fatty acid (FA, lipid resonances δ 0.9, 1.3 and 1.6 ppm) and polyunsaturated fatty acid (PUFA, lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) will be evaluated on MRS, with ratios normalized with total TG value.
|
Total
n=69 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Continuous
|
56.0 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
58.9 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
56.9 years
STANDARD_DEVIATION 7.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthWe quantified the total myocardial TG resonance as well as its components including FA (lipid resonances δ 0.9, 1.3 and 1.6 ppm) and UFA (lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) from water-suppressed spectra. We also determined the water resonance (\~ δ 4.7 ppm) from spectra without water suppression. Myocardial TG content relative to water as well as relative amounts of myocardial TG was calculated from the available data.
Outcome measures
| Measure |
Unstable HF Group
n=25 Participants
Patients with acute HF episode with hospitalization treatment within 12 months, currently LVEF\<50%. Proton (1H-) magnetic resonance (MR) spectroscopy.
Proton (1H-) magnetic resonance (MR) spectroscopy: PRESS localized 1D MRS sequence was used on a 3-T MR system. The lipid resonances will be analyzed using the LC-Model algorithm, and a Cramer-Rao lower bound (CRLB) threshold of 50% was used as quality control. We quantified the total myocardial TG resonance as well as its components including FA (lipid resonances δ 0.9, 1.3 and 1.6 ppm) and UFA (lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) from water-suppressed spectra. We also determined the water resonance (\~ δ 4.7 ppm) from spectra without water suppression. Myocardial TG content relative to water as well as relative amounts of myocardial TG was calculated from the available data.
|
Stable HF Group
n=23 Participants
Patients with acute HF episode with hospitalization treatment within 12 months, LVEF\>=50%. Proton (1H-) magnetic resonance (MR) spectroscopy.
Proton (1H-) magnetic resonance (MR) spectroscopy: PRESS localized 1D MRS sequence was used on a 3-T MR system. The lipid resonances will be analyzed using the LC-Model algorithm, and a Cramer-Rao lower bound (CRLB) threshold of 50% was used as quality control. We quantified the total myocardial TG resonance as well as its components including FA (lipid resonances δ 0.9, 1.3 and 1.6 ppm) and UFA (lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) from water-suppressed spectra. We also determined the water resonance (\~ δ 4.7 ppm) from spectra without water suppression. Myocardial TG content relative to water as well as relative amounts of myocardial TG was calculated from the available data.
|
Control Group
n=21 Participants
Age- and gender-matched healthy volunteers recruited as normal control group. Proton (1H-) magnetic resonance (MR) spectroscopy.
Proton (1H-) magnetic resonance (MR) spectroscopy: PRESS localized 1D MRS sequence was used on a 3-T MR system. The lipid resonances will be analyzed using the LC-Model algorithm, and a Cramer-Rao lower bound (CRLB) threshold of 50% was used as quality control. We quantified the total myocardial TG resonance as well as its components including FA (lipid resonances δ 0.9, 1.3 and 1.6 ppm) and UFA (lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) from water-suppressed spectra. We also determined the water resonance (\~ δ 4.7 ppm) from spectra without water suppression. Myocardial TG content relative to water as well as relative amounts of myocardial TG was calculated from the available data.
|
|---|---|---|---|
|
Myocaridal Lipid on MRS
triglyceride/water
|
1.72 ratios
Standard Deviation 2.63
|
1.18 ratios
Standard Deviation 1.82
|
1.53 ratios
Standard Deviation 1.78
|
|
Myocaridal Lipid on MRS
fatty acids/water
|
0.93 ratios
Standard Deviation 2.13
|
0.97 ratios
Standard Deviation 1.64
|
1.39 ratios
Standard Deviation 1.67
|
|
Myocaridal Lipid on MRS
unsaturated fatty acids/water
|
0.79 ratios
Standard Deviation 1.38
|
0.21 ratios
Standard Deviation 0.28
|
0.14 ratios
Standard Deviation 0.20
|
|
Myocaridal Lipid on MRS
fatty acids/triglyceride
|
0.53 ratios
Standard Deviation 0.41
|
0.68 ratios
Standard Deviation 0.40
|
0.71 ratios
Standard Deviation 0.32
|
|
Myocaridal Lipid on MRS
unsaturated fatty acids/triglyceride
|
0.47 ratios
Standard Deviation 0.41
|
0.32 ratios
Standard Deviation 0.40
|
0.29 ratios
Standard Deviation 0.32
|
Adverse Events
Unstable HF Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stable HF Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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
Gigin Lin, MD, PhD
Department of Radiology, Chang Gung Memorial Hospital
Phone: 886-3-3281200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place