Left Ventricular DysfunctionNCT01110395
Phosphorous Magnetic Resonance Spectroscopy of Heart
A study testing MR Spectroscopy in people with Left Ventricular Dysfunction, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Heart needs constant supply of energy to continue working. Phosphorus magnetic resonance spectroscopy allows us to measure energy produced in the heart. The purpose of this study is to determine if the energy production is reduced in failing heart. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Dysfunction
- What is being tested?
- MR Spectroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 2011
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with left ventricular dysfunction
Who cannot join
- Age < 18, pregnant, history of excessive alcohol use, or any condition (e.g. claustrophobia, a pacemaker) that would prevent him/her from completing the magnetic resonance spectroscopy study
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: 31P Magnetic Resonance Spectroscopy of Heart
Heart needs constant supply of energy to continue working. Phosphorus magnetic resonance spectroscopy allows us to measure energy produced in the heart. The purpose of this study is to determine if the energy production is reduced in failing heart.
Read the detailed description
We will use non-invasive phosphorus magnetic resonance spectroscopy technique to measure creatine kinase (CK) flux in failing heart. The studies will be done on Siemens 3.0T human system. We will recruit subjects with LV dysfunction due to prior anterior wall myocardial infarction.
- Conditions
- Left Ventricular Dysfunction
- Being tested
- MR Spectroscopy
- Medical subject headings
- Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR SpectroscopyDiagnostic test
MR spectroscopy of myocardial
| Study group | Role | What they receive |
|---|---|---|
| MR Spectroscopy Post-Heart Transplant | Experimental | Patients post heart transplant getting heart biopsy Receives: Diagnostic Test: MR Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
An MR Spectroscopy Showing Signal to Noise Ratio to Determine the Level of Heart Failure
Measured: 1-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startJun 2009
- Primary completionJun 2011
- Study completionJun 2011
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 (4)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular DysfunctionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adil Bashir, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110395
- Sponsor's protocol ID
- 09-0533
- Status last verified
- Jul 2020
- First submitted
- 22 Apr 2010
- Last updated
- 7 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lipskaya TY. Mitochondrial creatine kinase: properties and function. Biochemistry (Mosc). 2001 Oct;66(10):1098-111. doi: 10.1023/a:1012428812780.
PubMed 11736631Nascimben L, Ingwall JS, Pauletto P, Friedrich J, Gwathmey JK, Saks V, Pessina AC, Allen PD. Creatine kinase system in failing and nonfailing human myocardium. Circulation. 1996 Oct 15;94(8):1894-901. doi: 10.1161/01.cir.94.8.1894.
PubMed 8873665De Sousa E, Veksler V, Minajeva A, Kaasik A, Mateo P, Mayoux E, Hoerter J, Bigard X, Serrurier B, Ventura-Clapier R. Subcellular creatine kinase alterations. Implications in heart failure. Circ Res. 1999 Jul 9;85(1):68-76. doi: 10.1161/01.res.85.1.68.
PubMed 10400912Nascimben L, Friedrich J, Liao R, Pauletto P, Pessina AC, Ingwall JS. Enalapril treatment increases cardiac performance and energy reserve via the creatine kinase reaction in myocardium of Syrian myopathic hamsters with advanced heart failure. Circulation. 1995 Mar 15;91(6):1824-33. doi: 10.1161/01.cir.91.6.1824.
PubMed 7882493
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 31P Magnetic Resonance Spectroscopy of Heart
- ClinicalTrials.gov ID
- NCT01110395
- Acronym / sponsor ID
- 09-0533
- Conditions
- Left Ventricular Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jun 2009 (actual)
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 26 Apr 2010 (estimated)
- Results
- Posted 7 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heart needs constant supply of energy to continue working. Phosphorus magnetic resonance spectroscopy allows us to measure energy produced in the heart. The purpose of this study is to determine if the energy production is reduced in failing heart.
Detailed description
We will use non-invasive phosphorus magnetic resonance spectroscopy technique to measure creatine kinase (CK) flux in failing heart. The studies will be done on Siemens 3.0T human system. We will recruit subjects with LV dysfunction due to prior anterior wall myocardial infarction.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR Spectroscopy Post-Heart Transplant | Experimental | Diagnostic Test: MR SpectroscopyPatients post heart transplant getting heart biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals with left ventricular dysfunction
Key exclusion criteria (1 listed)
- Age < 18, pregnant, history of excessive alcohol use, or any condition (e.g. claustrophobia, a pacemaker) that would prevent him/her from completing the magnetic resonance spectroscopy study
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 |
|---|---|---|
| MR SpectroscopyMR spectroscopy of myocardial | Diagnostic test | MR Spectroscopy Post-Heart Transplant |
Primary outcome
An MR Spectroscopy Showing Signal to Noise Ratio to Determine the Level of Heart Failure
Time frame: 1-2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11736631Lipskaya TY. Mitochondrial creatine kinase: properties and function. Biochemistry (Mosc). 2001 Oct;66(10):1098-111. doi: 10.1023/a:1012428812780.
- Background: PubMed 8873665Nascimben L, Ingwall JS, Pauletto P, Friedrich J, Gwathmey JK, Saks V, Pessina AC, Allen PD. Creatine kinase system in failing and nonfailing human myocardium. Circulation. 1996 Oct 15;94(8):1894-901. doi: 10.1161/01.cir.94.8.1894.
- Background: PubMed 10400912De Sousa E, Veksler V, Minajeva A, Kaasik A, Mateo P, Mayoux E, Hoerter J, Bigard X, Serrurier B, Ventura-Clapier R. Subcellular creatine kinase alterations. Implications in heart failure. Circ Res. 1999 Jul 9;85(1):68-76. doi: 10.1161/01.res.85.1.68.
- Background: PubMed 7882493Nascimben L, Friedrich J, Liao R, Pauletto P, Pessina AC, Ingwall JS. Enalapril treatment increases cardiac performance and energy reserve via the creatine kinase reaction in myocardium of Syrian myopathic hamsters with advanced heart failure. Circulation. 1995 Mar 15;91(6):1824-33. doi: 10.1161/01.cir.91.6.1824.
- Individual participant dataSharing planned: No
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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.
Adil Bashir, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR Spectroscopy in people with Left Ventricular Dysfunction, run by Washington University School of Medicine at 1 site in United States.
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 1 inclusion and 1 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 7 Aug 2020. 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 United States. 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 7 Aug 2020). 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?
An MR Spectroscopy Showing Signal to Noise Ratio to Determine the Level of Heart Failure (time frame: 1-2 days). 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 NCT01110395, which also lists 4 linked publications.
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 7 Aug 2020.