CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 71 enrolled
Drug / intervention
Proton (1H-) magnetic resonance (MR) spectroscopyother
Likely dose
Not stated in record
Key inclusion· 5
  • Heart failure patients diagnosed at Keelung Chang Gung Memorial Hospital
  • Age 20-80 years
  • No previous history of coronary artery disease
  • Willing to undergo standard treatment and follow-up
Key exclusion· 5
  • Judged noncompliant to treatment or inaccessible for follow-up
  • Contraindications to MR scanning (claustrophobia, pacemaker, metal implants, or inability to cooperate)
  • Severe renal impairment (GFR <30 mL/min/1.73m²)
  • Pregnant or breast-feeding

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02378402
NCT02378402N/ACompleted

Exploring Myocardial Lipid and Creatine as Imaging Biomarkers for Patients of Heart Failure

Chang Gung Memorial Hospital·observational·Posted Mar 4, 2015·Updated Oct 21, 2019

In Brief

An observational study evaluating Proton (1H-) magnetic resonance (MR) spectroscopy for Myocardial Lipid. Completed, enrolled 71 participants across 1 site.

Detailed Summary

The objective of this 3-year project is to develop myocardial MRS, in particular lipid (triglyceride) and creatine resonances, as imaging biomarkers for patients with heart failure (HF). Investigators will elucidate how and, to what extent, lipid and creatine levels of the heart contribute to heart failure. The first year is a cross-sectional study. Investigators aim to compare the MRS of normal subjects and that of stable HF patients in recovery with normal or impaired ejection fraction (EF). Total 60 subjects will be enrolled, with 20 subjects in each group. In the 2nd and 3rd years, investigators plan a prospective longitudinal study of 40 subjects. Enrolled patients will be evaluated with cardiac MRS at three time points, i.e., disease onset, 6 months and one year after treatment, and will be followed up until the end of this project (1.5\~3-year follow up). In total 120 MR scans will be performed in the 2nd and 3rd years. The resonances from cardiac MRS, including creatine and lipids, will be correlated with the disease course, patient biochemistry data and clinical outcome. Investigators expect to make MRS to become an integral part of a clinical cardiac MR protocol.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesTaiwan
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 4, 2015
Enrollment StartJan 1, 2014
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.3 years ago

Interventions

Proton (1H-) magnetic resonance (MR) spectroscopyother

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.