Multimodality Imaging Assessment of the Severity of Mitral Regurgitation
NCT ID: NCT06266858
Last Updated: 2024-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2022-12-01
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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UCG in pre-anaesthetic group
The fasting patients receive UCG in pre-anaesthetic.
UCG
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.
fasting
At the beginning of the study, the patients need to fast when receive UCG.
UCG in post-anaesthetic group
The fasting patients receive UCG in post-anaesthetic.
UCG
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.
fasting
At the beginning of the study, the patients need to fast when receive UCG.
UCG in post-rehydration group
The fasting patients in anaesthetised receive UCG in post-rehydration.
rehydration
The fasting patients in anaesthetised receive saline rehydration to maintain central venous pressure of 6-8 cmH2O when undergoing UCG.
UCG
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.
fasting
At the beginning of the study, the patients need to fast when receive UCG.
cardiac magnetic resonance （CMR） group
The non-fasting patients receive CMR in another time.
CMR
CMR may be more accurate than UCG in assessing MR severity. In another time, the patients receive CMR.
Interventions
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rehydration
The fasting patients in anaesthetised receive saline rehydration to maintain central venous pressure of 6-8 cmH2O when undergoing UCG.
UCG
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.
CMR
CMR may be more accurate than UCG in assessing MR severity. In another time, the patients receive CMR.
fasting
At the beginning of the study, the patients need to fast when receive UCG.
Eligibility Criteria
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Inclusion Criteria
2. all-caused moderate or severe MR assessed by Trans-Thoracic Echocardiography (TTE) : 1) EROA ≥0.3cm\^2; 2) RVol ≥45ml
3. The patient has signed an informed consent form.
Exclusion Criteria
2. acute heart failure or acute worsening of chronic heart failure requiring vasoactive drug therapy
3. severe infections, septicaemia
4. severe hepatic insufficiency ( Child-Pugh class C)
5. severe renal insufficiency ( chronic kidney disease (CKD) stage 5: estimated glomerular filtration rate (eGFR) \<15ml/min or dialysis)
6. hypotensive state, shock ( systolic blood pressure \<90mmHg or mean arterial pressure \<70mmHg with tissue hypoperfusion and urine output \<30ml/h)
7. 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
8. contraindication for Trans-Esophageal Echocardiography (TEE) such as oesophageal constriction, oesophageal tumour, oesophageal fistula, oesophageal varices, cervical vertebral instability
9. contraindication for CMR such as metal foreign matter in the body, claustrophobia
10. contraindication for intravenous anaesthesia such as allergy to anaesthetics
11. pregnancy or breastfeeding
12. The patient does not sign an informed consent form.
13. Due to other reasons the patient is not suitable for enrollment assessed by the researcher.
18 Years
ALL
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Maohuan Lin
Professor
Principal Investigators
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Maohuan Lin, PhD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Locations
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Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SYSKY-2022-407-02
Identifier Type: -
Identifier Source: org_study_id
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