Mitral Regurgitation
Conditions
Keywords
mitral regurgitation, ultrasonic cardiography, cardiac magnetic resonance
Brief summary
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.
Interventions
OTHERrehydration
The fasting patients in anaesthetised receive saline rehydration to maintain central venous pressure of 6-8 cmH2O when undergoing UCG.
DIAGNOSTIC_TESTUCG
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.
DIAGNOSTIC_TESTCMR
CMR may be more accurate than UCG in assessing MR severity. In another time, the patients receive CMR.
OTHERfasting
At the beginning of the study, the patients need to fast when receive UCG.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age ≥ 18 years old 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
1. unstable angina, acute myocardial infarction and surgical history of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) within 3 months before recruit 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| effective regurgitant orifice area (EROA) | 1 day during an examination | EROA measured by multiple imaging methods when patient is in the different situation. |
| mitral regurgitant volume (RVol) | 1 day during an examination | RVol measured by multiple imaging methods when patient is in the different |
| mitral regurgitant fraction (RF) | 1 day during an examination | RF measured by multiple imaging methods when patient is in the different |
Countries
China
Contacts
Primary ContactMaohuan Lin, PhD
Outcome results
None listed