Cardiac FailureNCT07889076
The Development and Optimization of a Cardiac Magnetic Resonance Imaging Protocol in a 3 Tesla Scanner
An observational study of Cardiac Failure, run by Wang . Jiun-Jie at 1 site in Taiwan.
Trial summary
In recent years, evaluating cardiac function with magnetic resonance imaging (MRI) has drawn widespread interest. However, cardiac MRI is prone to severe motion artifacts from cardiac contraction, frequently requiring complex triggering procedures to enhance image quality-a task that typically demands a highly skilled… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Failure
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The healthy control will be recruited from the local community in northern Taiwan.
Who may be able to join
- Heart Failure Group: 30 subjects
- All participants should be aged between 20 and 70 year old.
- Established diagnosis by a cardiological examination.
- Able to understand and provide signed informed consent.
- Patients must be willing to undergo standard treatment and follow up in the Heart Failure Center.
- Healthy Controls: subjects = 30 (20 in the first year and 10 in the second year, cross-sectional)
Show all 15Show fewer
- Aged between 20 and 70 year old.
- Able to understand and provide signed informed consent.
- Without documented cardiac disorder.
- Age and gender matched the heart failure group
- Healthy Controls for optimization: subjects = 60 (20 in each year, for protocol optimization )
- Aged between 20 and 70 year old.
- Able to understand and provide signed informed consent
- without documented cardiac disorder
- Age and gender matched the heart failure group
Who cannot join
- The following exclusion criteria apply to all groups.
- Patients who are judged to be noncompliant to treatment or not accessible for follow up.
- Unable to cooperate for MRI study due to mental status
- Patients with contraindications to MR scanning, such as claustrophobia, cardiac pacemaker, metal implants.
- Pregnant or breast feeding women.
- Severe renal function impairment (glomerular filtration rate less than 30 mL/min/1.73m2).
- History of open-heart surgery.
Trial locations and contacts
1 site in 1 country.
About this study
In recent years, evaluating cardiac function with magnetic resonance imaging (MRI) has drawn widespread interest. However, cardiac MRI is prone to severe motion artifacts from cardiac contraction, frequently requiring complex triggering procedures to enhance image quality-a task that typically demands a highly skilled technologist to execute within limited clinical time. As there is currently no optimized cardiac MRI protocol at Chang Gung Memorial Hospital, this subproject aims to first establish a clinically feasible, optimized protocol to support other subprojects and future studies. The investigators will develop a standard operating procedure (SOP) and subsequently use it to evaluate recovery in heart failure patients.
Over this three-year project, the investigators plan to use MRI to evaluate cardiac morphology and function in heart failure patients. In Year 1, the investigators will establish a clinically feasible protocol to assess myocardial stability; baseline images from healthy controls will be incorporated into the integrated project. In Year 2, the investigators will introduce accelerated imaging techniques, assess the correlation between disease severity and MRI findings, and measure cardiac diffusion parameters. In Year 3, the investigators will follow heart failure patients to monitor their recovery process.
Read the detailed description
Patients with myocardial diseases might suffer from a serious impact on daily living activity, which could lead to increased care burden. Because of the very low capacity in myocardial regeneration, tissue damage by myocardial necrosis is usually irreversible. Therefore, great interest has been raised to monitor the healthy myocardial conditions, to prevent the occurrence and the subsequent deterioration of the myocardial disease, preferably with non-invasive methods. Computed tomography (CT), ultrasound, and magnetic resonance image (MRI) were widely used as image-based diagnostic techniques without invasive for myocardial tissue. In this regard, although CT could provide superior spatial resolution, its performance at discriminating between soft-tissue lesions of cardiomyopathy might be less than satisfactory. The limited temporal resolution, the risk from radiation, and the use of contrast agent might raise further concerns. Cardiac MRI (CMRI) might provide a choice because of the improved contrast and the non-invasive nature without the need to use a contrast agent.
The myocardial T1 and T2∗ relaxation time, as derived from CMRI, have been previously reported in many cardiomyopathies such as acute myocardial infarction, fibrosis, and iron deposition. For diagnosis, quantitative values of relaxation time were often obtained from either healthy myocardial tissue, such as the remotely-located unaffected tissue from the same participant, or healthy volunteers. These quantitative maps provide an objective assessment of the myocardial tissue properties in comparison to the disease-induced abnormalities or diffused changes within myocardium.
The Caucasian population usually has a high cardiovascular-disease-related mortality rate. In contrast, the Asian population has a higher mortality rate by stroke, which was often attributed to the poor control of cardiovascular risk factors, such as high blood pressure or cholesterol level. The relaxation time in the healthy myocardium was previously reported from the Caucasian population. To evaluate the potential relationship between clinical parameters and quantitative mapping from CMRI, mastered the reference values of T1 and T2∗ relaxation time of myocardium in healthy populations were important. This study aimed to measure and report the T1 and T2∗ relaxation time of myocardium in healthy Taiwanese participants. The investigators further investigated the association between T1, T2∗ relaxation time of myocardium, and clinical parameters, including blood pressure, pulses rate, and ejection fraction.
- Conditions
- Cardiac Failure
- Keywords
- Magnetic Resonance Imaging, cardiac failure, optimization
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls Group | * Aged between 20 and 70 year old. * Able to understand and provide signed informed consent. * Without documented cardiac disorder. * Age and gender matched the heart failure group | |
| Healthy Controls for optimization group | * Aged between 20 and 70 year old. * Able to understand and provide signed informed consent * without documented cardiac disorder * Age and gender matched the heart failure group | |
| Heart Failure Group | * All participants should be aged between 20 and 70 year old. * Established diagnosis by a cardiological examination. * Able to understand and provide signed informed consent. * Patients must be willing to undergo standard treatment and follow up in the Heart Failure Center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI acquisition
73 normal participants assesed by MRI
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startJan 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac FailureStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wang . Jiun-Jie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wang . Jiun-Jie, Chang Gung Memorial Hospital
- Investigators
- Jiun-Jie Wang, PhD, Principal investigator, ChangGung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889076
- Sponsor's protocol ID
- 102-2547B
- Status last verified
- Oct 2026
- First submitted
- 12 Aug 2022
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Optimization of a Cardiac Magnetic Resonance Imaging Protocol in a 3 Tesla Scanner
- ClinicalTrials.gov ID
- NCT07889076
- Acronym / sponsor ID
- 102-2547B
- Conditions
- Cardiac Failure
- Keywords
- Magnetic Resonance Imaging, cardiac failure, optimization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Wang . Jiun-JieUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In recent years, evaluating cardiac function with magnetic resonance imaging (MRI) has drawn widespread interest. However, cardiac MRI is prone to severe motion artifacts from cardiac contraction, frequently requiring complex triggering procedures to enhance image quality-a task that typically demands a highly skilled technologist to execute within limited clinical time. As there is currently no optimized cardiac MRI protocol at Chang Gung Memorial Hospital, this subproject aims to first establish a clinically feasible, optimized protocol to support other subprojects and future studies. The investigators will develop a standard operating procedure (SOP) and subsequently use it to evaluate recovery in heart failure patients.
Over this three-year project, the investigators plan to use MRI to evaluate cardiac morphology and function in heart failure patients. In Year 1, the investigators will establish a clinically feasible protocol to assess myocardial stability; baseline images from healthy controls will be incorporated into the integrated project. In Year 2, the investigators will introduce accelerated imaging techniques, assess the correlation between disease severity and MRI findings, and measure cardiac diffusion parameters. In Year 3, the investigators will follow heart failure patients to monitor their recovery process.
Detailed description
Patients with myocardial diseases might suffer from a serious impact on daily living activity, which could lead to increased care burden. Because of the very low capacity in myocardial regeneration, tissue damage by myocardial necrosis is usually irreversible. Therefore, great interest has been raised to monitor the healthy myocardial conditions, to prevent the occurrence and the subsequent deterioration of the myocardial disease, preferably with non-invasive methods. Computed tomography (CT), ultrasound, and magnetic resonance image (MRI) were widely used as image-based diagnostic techniques without invasive for myocardial tissue. In this regard, although CT could provide superior spatial resolution, its performance at discriminating between soft-tissue lesions of cardiomyopathy might be less than satisfactory. The limited temporal resolution, the risk from radiation, and the use of contrast agent might raise further concerns. Cardiac MRI (CMRI) might provide a choice because of the improved contrast and the non-invasive nature without the need to use a contrast agent.
The myocardial T1 and T2∗ relaxation time, as derived from CMRI, have been previously reported in many cardiomyopathies such as acute myocardial infarction, fibrosis, and iron deposition. For diagnosis, quantitative values of relaxation time were often obtained from either healthy myocardial tissue, such as the remotely-located unaffected tissue from the same participant, or healthy volunteers. These quantitative maps provide an objective assessment of the myocardial tissue properties in comparison to the disease-induced abnormalities or diffused changes within myocardium.
The Caucasian population usually has a high cardiovascular-disease-related mortality rate. In contrast, the Asian population has a higher mortality rate by stroke, which was often attributed to the poor control of cardiovascular risk factors, such as high blood pressure or cholesterol level. The relaxation time in the healthy myocardium was previously reported from the Caucasian population. To evaluate the potential relationship between clinical parameters and quantitative mapping from CMRI, mastered the reference values of T1 and T2∗ relaxation time of myocardium in healthy populations were important. This study aimed to measure and report the T1 and T2∗ relaxation time of myocardium in healthy Taiwanese participants. The investigators further investigated the association between T1, T2∗ relaxation time of myocardium, and clinical parameters, including blood pressure, pulses rate, and ejection fraction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls Group | – | –* Aged between 20 and 70 year old. * Able to understand and provide signed informed consent. * Without documented cardiac disorder. * Age and gender matched the heart failure group |
| Healthy Controls for optimization group | – | –* Aged between 20 and 70 year old. * Able to understand and provide signed informed consent * without documented cardiac disorder * Age and gender matched the heart failure group |
| Heart Failure Group | – | –* All participants should be aged between 20 and 70 year old. * Established diagnosis by a cardiological examination. * Able to understand and provide signed informed consent. * Patients must be willing to undergo standard treatment and follow up in the Heart Failure Center. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The healthy control will be recruited from the local community in northern Taiwan.
Key inclusion criteria (15 listed)
- Heart Failure Group: 30 subjects
- All participants should be aged between 20 and 70 year old.
- Established diagnosis by a cardiological examination.
- Able to understand and provide signed informed consent.
- Patients must be willing to undergo standard treatment and follow up in the Heart Failure Center.
Key exclusion criteria (7 listed)
- The following exclusion criteria apply to all groups.
- Patients who are judged to be noncompliant to treatment or not accessible for follow up.
- Unable to cooperate for MRI study due to mental status
- Patients with contraindications to MR scanning, such as claustrophobia, cardiac pacemaker, metal implants.
- Pregnant or breast feeding women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MRI acquisition
Time frame: 3 years
73 normal participants assesed by MRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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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.
Jiun-Jie Wang, PhD principal investigator
ChangGung University
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 Cardiac Failure, run by Wang . Jiun-Jie 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 15 inclusion and 7 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 22 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MRI acquisition (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.