Myocardial LipidNCT02378402
Myocardial Lipid and Creatine of Heart Failure on MRS
An observational study of Myocardial Lipid, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Lipid
- What is being tested?
- Proton (1H-) magnetic resonance (MR) spectroscopy
- How many people
- 71 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to Dec 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with acute HF episode with hospitalization treatment within 12 months were enrolled.
Who may be able to join
- heart failure patients diagnosed in the Keelung Chang Gung Memorial Hospital
- without previous history of coronary artery disease
- patients must be ≥ 20 and ≤ 80 years of age
- patients must be willing to undergo standard treatment and follow up in the Heart Failure Center
- patients must be able to give informed consent.
Who cannot join
- patients who are judged to be noncompliant to treatment or not accessible for follow up
- patients with contraindications to MR scanning, such as claustrophobia, cardiac pacemaker, metal implants, or unable to cooperate for MRI study due to mental status
- Severe renal function impairment (glomerular filtration rate less than 30 mL/min/1.73m2)
- pregnant or breast-feeding status
- history of open-heart surgery.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Radiology, Chang Gung Memorial Hospital
Guishan, Taoyuan, 333
About this study
Official title: Exploring Myocardial Lipid and Creatine as Imaging Biomarkers for Patients of Heart Failure
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.
Read the detailed description
Heart failure (HF) is a major societal burden due to its high prevalence, poor prognosis and high cost. A potential therapeutic target is to supply the energy-starved heart. Lipid content of the heart is highly dynamic and myocardial lipid overload has been implicated in the pathophysiology of cardiac disease. The measurement of total creatine, a crucial actor in the creatine kinase system, gives an insight into the energy storage and buffering capacity in the heart. Magnetic Resonance Spectroscopy (MRS) is an imaging technique that allows non-invasive biochemical analysis in the clinical setting using routine MR scanner. It has the combined advantages of inherently providing molecular information, being free of ionizing radiation, and not requiring administration of external tracers. 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. The advance in knowledge is to prove the association between heart failure and myocardial impairment in lipids and/or creatine. The knowledge gained from MRS could potentially translate as a non-invasive biomarker for heart failure patients. This biomarker can help to early detect treatable causes of HF, and to monitor and evaluate treatment response in a non-invasive fashion. The inherited non-invasiveness and non-radiation nature makes MR an ideal technique for clinical application and biotechnology development.
- Conditions
- Myocardial Lipid
- Being tested
- Proton (1H-) magnetic resonance (MR) spectroscopy
- Keywords
- Creatine, heart failure, lipid, MRS, myocardium
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Unstable HF group | Patients with acute HF episode with hospitalization treatment within 12 months, currently LVEF<50%. Proton (1H-) magnetic resonance (MR) spectroscopy. Receives: Other: Proton (1H-) magnetic resonance (MR) spectroscopy | |
| Stable HF group | Patients with acute HF episode with hospitalization treatment within 12 months, LVEF>=50%. Proton (1H-) magnetic resonance (MR) spectroscopy. Receives: Other: Proton (1H-) magnetic resonance (MR) spectroscopy | |
| Control group | Age- and gender-matched healthy volunteers recruited as normal control group. Proton (1H-) magnetic resonance (MR) spectroscopy. Receives: Other: Proton (1H-) magnetic resonance (MR) spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocaridal Lipid on MRS
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.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial LipidStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gigin Lin, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378402
- Sponsor's protocol ID
- 102-2772A3
- Status last verified
- Oct 2019
- First submitted
- 27 Feb 2015
- Last updated
- 21 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liao PA, Lin G, Tsai SY, Wang CH, Juan YH, Lin YC, Wu MT, Yang LY, Liu MH, Chang TC, Lin YC, Huang YC, Huang PC, Wang JJ, Ng SH, Ng KK. Myocardial triglyceride content at 3 T cardiovascular magnetic resonance and left ventricular systolic function: a cross-sectional study in patients hospitalized with acute heart failure. J Cardiovasc Magn Reson. 2016 Feb 5;18:9. doi: 10.1186/s12968-016-0228-3.
PubMed 26850626
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Myocardial Lipid and Creatine as Imaging Biomarkers for Patients of Heart Failure
- ClinicalTrials.gov ID
- NCT02378402
- Acronym / sponsor ID
- 102-2772A3
- Conditions
- Myocardial Lipid
- Keywords
- Creatine, heart failure, lipid, MRS, myocardium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Posted 21 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Heart failure (HF) is a major societal burden due to its high prevalence, poor prognosis and high cost. A potential therapeutic target is to supply the energy-starved heart. Lipid content of the heart is highly dynamic and myocardial lipid overload has been implicated in the pathophysiology of cardiac disease. The measurement of total creatine, a crucial actor in the creatine kinase system, gives an insight into the energy storage and buffering capacity in the heart. Magnetic Resonance Spectroscopy (MRS) is an imaging technique that allows non-invasive biochemical analysis in the clinical setting using routine MR scanner. It has the combined advantages of inherently providing molecular information, being free of ionizing radiation, and not requiring administration of external tracers. 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. The advance in knowledge is to prove the association between heart failure and myocardial impairment in lipids and/or creatine. The knowledge gained from MRS could potentially translate as a non-invasive biomarker for heart failure patients. This biomarker can help to early detect treatable causes of HF, and to monitor and evaluate treatment response in a non-invasive fashion. The inherited non-invasiveness and non-radiation nature makes MR an ideal technique for clinical application and biotechnology development.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unstable HF group | – | Other: Proton (1H-) magnetic resonance (MR) spectroscopyPatients with acute HF episode with hospitalization treatment within 12 months, currently LVEF<50%. Proton (1H-) magnetic resonance (MR) spectroscopy. |
| Stable HF group | – | Other: Proton (1H-) magnetic resonance (MR) spectroscopyPatients with acute HF episode with hospitalization treatment within 12 months, LVEF>=50%. Proton (1H-) magnetic resonance (MR) spectroscopy. |
| Control group | – | Other: Proton (1H-) magnetic resonance (MR) spectroscopyAge- and gender-matched healthy volunteers recruited as normal control group. Proton (1H-) magnetic resonance (MR) spectroscopy. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute HF episode with hospitalization treatment within 12 months were enrolled.
Key inclusion criteria (5 listed)
- heart failure patients diagnosed in the Keelung Chang Gung Memorial Hospital
- without previous history of coronary artery disease
- patients must be ≥ 20 and ≤ 80 years of age
- patients must be willing to undergo standard treatment and follow up in the Heart Failure Center
- patients must be able to give informed consent.
Key exclusion criteria (5 listed)
- patients who are judged to be noncompliant to treatment or not accessible for follow up
- patients with contraindications to MR scanning, such as claustrophobia, cardiac pacemaker, metal implants, or unable to cooperate for MRI study due to mental status
- Severe renal function impairment (glomerular filtration rate less than 30 mL/min/1.73m2)
- pregnant or breast-feeding status
- history of open-heart surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton (1H-) magnetic resonance (MR) spectroscopyPRESS 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. | Other | Control group, Stable HF group, Unstable HF group |
Primary outcome
Myocaridal Lipid on MRS
Time frame: 12 month
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26850626Liao PA, Lin G, Tsai SY, Wang CH, Juan YH, Lin YC, Wu MT, Yang LY, Liu MH, Chang TC, Lin YC, Huang YC, Huang PC, Wang JJ, Ng SH, Ng KK. Myocardial triglyceride content at 3 T cardiovascular magnetic resonance and left ventricular systolic function: a cross-sectional study in patients hospitalized with acute heart failure. J Cardiovasc Magn Reson. 2016 Feb 5;18:9. doi: 10.1186/s12968-016-0228-3.
- Myocardial triglyceride content at 3 T cardiovascular magnetic resonance and left ventricular systolic function: a cross-sectional study in patients hospitalized with acute heart failure.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Lipid, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocaridal Lipid on MRS (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02378402, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.