Mitral RegurgitationNCT06266858
Multimodality Imaging Assessment of the Severity of Mitral Regurgitation
A study testing rehydration, UCG and CMR in people with Mitral Regurgitation, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
To investigate to assess the severity of mitral regurgitation by multimodality imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- rehydration, UCG and CMR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 30 Jun 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years old
- all-caused moderate or severe MR assessed by Trans-Thoracic Echocardiography (TTE) : 1) EROA ≥0.3cm^2; 2) RVol ≥45ml
- The patient has signed an informed consent form.
Who cannot join
- unstable angina, acute myocardial infarction and surgical history of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) within 3 months before recruit
- acute heart failure or acute worsening of chronic heart failure requiring vasoactive drug therapy
- severe infections, septicaemia
- severe hepatic insufficiency ( Child-Pugh class C)
- severe renal insufficiency ( chronic kidney disease (CKD) stage 5: estimated glomerular filtration rate (eGFR) <15ml/min or dialysis)
- hypotensive state, shock ( systolic blood pressure <90mmHg or mean arterial pressure <70mmHg with tissue hypoperfusion and urine output <30ml/h)
Show all 13Show fewer
- uncontrolled diseases of the haematological system: acute gastrointestinal bleeding, intracranial haemorrhage or haemorrhage from other organs, acute pulmonary embolism or deep vein thrombosis, congenital or acquired haemorrhagic disease such as haemophilia, anaphylactic purpura and acute leukaemia, severe abnormalities in haematological parameters such as platelet count <20*10^9/l and international normalized ratio (INR) >3
- contraindication for Trans-Esophageal Echocardiography (TEE) such as oesophageal constriction, oesophageal tumour, oesophageal fistula, oesophageal varices, cervical vertebral instability
- contraindication for CMR such as metal foreign matter in the body, claustrophobia
- contraindication for intravenous anaesthesia such as allergy to anaesthetics
- pregnancy or breastfeeding
- The patient does not sign an informed consent form.
- Due to other reasons the patient is not suitable for enrollment assessed by the researcher.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Maohuan Lin, PhD, 13580575861, maohuan_lin@163.com
About this study
Official title: A Single-Center, Open-Label Study to Assess the Severity of Mitral Regurgitation With Multimodality Imaging
To investigate to assess the severity of mitral regurgitation by multimodality imaging.
Read the detailed description
In the single-center and open-label study, the researcher will compare the changes of ultrasonic cardiography (UCG) parameters when patients in fasting, anaesthesia and rehydration firstly. The aims are to clarify the effect of fasting and anaesthesia on the assessment of mitral regurgitation (MR) severity and the corrective effect of intravenous rehydration. The researcher then will investigate the correlation and consistency of multimodality imaging in assessing the severity of mitral regurgitation. The aim is to acquire more accurate, objective and reproducible parameters, to provide new solution for the precise assessment of MR severity and to guide the selection of clinical treatment and timing.
- Conditions
- Mitral Regurgitation
- Being tested
- rehydration, UCG, CMR, fasting
- Keywords
- mitral regurgitation, ultrasonic cardiography, cardiac magnetic resonance
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehydrationOther
The fasting patients in anaesthetised receive saline rehydration to maintain central venous pressure of 6-8 cmH2O when undergoing UCG.
UCGDiagnostic test
UCG is the most common imaging modality to assess the mitral regurgitation in clinical and also is the primary modality recommended by guidelines. At the beginning of the study, the fasting patients receive UCG in the different situation such as pre-anaesthetic, post-anaesthetic and post-rehydration.
CMRDiagnostic test
CMR may be more accurate than UCG in assessing MR severity. In another time, the patients receive CMR.
fastingOther
At the beginning of the study, the patients need to fast when receive UCG.
| Study group | Role | What they receive |
|---|---|---|
| UCG in pre-anaesthetic group | Other | The fasting patients receive UCG in pre-anaesthetic. Receives: Diagnostic Test: UCG; Other: fasting |
| UCG in post-anaesthetic group | Other | The fasting patients receive UCG in post-anaesthetic. Receives: Diagnostic Test: UCG; Other: fasting |
| UCG in post-rehydration group | Other | The fasting patients in anaesthetised receive UCG in post-rehydration. Receives: Other: rehydration; Diagnostic Test: UCG; Other: fasting |
| cardiac magnetic resonance （CMR） group | Other | The non-fasting patients receive CMR in another time. Receives: Diagnostic Test: CMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
effective regurgitant orifice area (EROA)
EROA measured by multiple imaging methods when patient is in the different situation.
Measured: 1 day during an examination
mitral regurgitant volume (RVol)
RVol measured by multiple imaging methods when patient is in the different
Measured: 1 day during an examination
mitral regurgitant fraction (RF)
RF measured by multiple imaging methods when patient is in the different
Measured: 1 day during an examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Dec 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maohuan Lin, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Maohuan Lin, PhD, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266858
- Sponsor's protocol ID
- SYSKY-2022-407-02
- Status last verified
- Feb 2024
- First submitted
- 21 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label Study to Assess the Severity of Mitral Regurgitation With Multimodality Imaging
- ClinicalTrials.gov ID
- NCT06266858
- Acronym / sponsor ID
- SYSKY-2022-407-02
- Conditions
- Mitral Regurgitation
- Keywords
- mitral regurgitation, ultrasonic cardiography, cardiac magnetic resonance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 20 Feb 2024 (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.
To investigate to assess the severity of mitral regurgitation by multimodality imaging.
Detailed description
In the single-center and open-label study, the researcher will compare the changes of ultrasonic cardiography (UCG) parameters when patients in fasting, anaesthesia and rehydration firstly. The aims are to clarify the effect of fasting and anaesthesia on the assessment of mitral regurgitation (MR) severity and the corrective effect of intravenous rehydration. The researcher then will investigate the correlation and consistency of multimodality imaging in assessing the severity of mitral regurgitation. The aim is to acquire more accurate, objective and reproducible parameters, to provide new solution for the precise assessment of MR severity and to guide the selection of clinical treatment and timing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| UCG in pre-anaesthetic group | Other | Diagnostic Test: UCG, Other: fastingThe fasting patients receive UCG in pre-anaesthetic. |
| UCG in post-anaesthetic group | Other | Diagnostic Test: UCG, Other: fastingThe fasting patients receive UCG in post-anaesthetic. |
| UCG in post-rehydration group | Other | Other: rehydration, Diagnostic Test: UCG, Other: fastingThe fasting patients in anaesthetised receive UCG in post-rehydration. |
| cardiac magnetic resonance （CMR） group | Other | Diagnostic Test: CMRThe non-fasting patients receive CMR in another time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 18 years old
- all-caused moderate or severe MR assessed by Trans-Thoracic Echocardiography (TTE) : 1) EROA ≥0.3cm^2; 2) RVol ≥45ml
- The patient has signed an informed consent form.
Key exclusion criteria (13 listed)
- unstable angina, acute myocardial infarction and surgical history of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) within 3 months before recruit
- acute heart failure or acute worsening of chronic heart failure requiring vasoactive drug therapy
- severe infections, septicaemia
- severe hepatic insufficiency ( Child-Pugh class C)
- severe renal insufficiency ( chronic kidney disease (CKD) stage 5: estimated glomerular filtration rate (eGFR) <15ml/min or dialysis)
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 |
|---|---|---|
| rehydrationThe fasting patients in anaesthetised receive saline rehydration to maintain central venous pressure of 6-8 cmH2O when undergoing UCG. | Other | UCG in post-rehydration group |
| UCGUCG is the most common imaging modality to assess the mitral regurgitation in clinical and also is the primary modality recommended by guidelines. At the beginning of the study, the fasting patients receive UCG in the different situation such as pre-anaesthetic, post-anaesthetic and post-rehydration. | Diagnostic test | UCG in post-anaesthetic group, UCG in post-rehydration group, UCG in pre-anaesthetic group |
| CMRCMR may be more accurate than UCG in assessing MR severity. In another time, the patients receive CMR. | Diagnostic test | cardiac magnetic resonance （CMR） group |
| fastingAt the beginning of the study, the patients need to fast when receive UCG. | Other | UCG in post-anaesthetic group, UCG in post-rehydration group, UCG in pre-anaesthetic group |
Primary outcome
effective regurgitant orifice area (EROA)
Time frame: 1 day during an examination
EROA measured by multiple imaging methods when patient is in the different situation.
mitral regurgitant volume (RVol)
Time frame: 1 day during an examination
RVol measured by multiple imaging methods when patient is in the different
mitral regurgitant fraction (RF)
Time frame: 1 day during an examination
RF measured by multiple imaging methods when patient is in the different
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
Related trials for Mitral Regurgitation
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Recruiting
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
Mitral Regurgitation, Mitral Valve Disease
Not yet recruitingObservational study
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
Mitral Valve Insufficiency
Recruiting
Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation
Heart Failure - NYHA II - IV, Mitral Regurgitation Functional
Not yet recruiting
Early Feasibility Study of the Capstan Medical TMVR System
Mitral Regurgitation (MR)
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.
Maohuan Lin, PhD principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rehydration, UCG and CMR in people with Mitral Regurgitation, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maohuan Lin, PhD (13580575861, maohuan_lin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effective regurgitant orifice area (EROA) (time frame: 1 day during an examination). The study lists 3 primary outcomes in all. 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 20 Feb 2024.