Multimodality Imaging Assessment of the Severity of Mitral Regurgitation

Not Applicable

Recruiting

• Conditions: Mitral Regurgitation
• Interventions: Diagnostic Test: UCG; Other: rehydration; Diagnostic Test: CMR; Other: fasting

• Registration Number: NCT06266858
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2024-01-21
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-18
• Last Update Submitted: 2024-02-18
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UCG in pre-anaesthetic group	fasting	The fasting patients receive UCG in pre-anaesthetic.
UCG in pre-anaesthetic group	UCG	The fasting patients receive UCG in pre-anaesthetic.
UCG in post-rehydration group	UCG	The fasting patients in anaesthetised receive UCG in post-rehydration.
UCG in post-anaesthetic group	fasting	The fasting patients receive UCG in post-anaesthetic.
UCG in post-rehydration group	rehydration	The fasting patients in anaesthetised receive UCG in post-rehydration.
UCG in post-rehydration group	fasting	The fasting patients in anaesthetised receive UCG in post-rehydration.
cardiac magnetic resonance （CMR） group	CMR	The non-fasting patients receive CMR in another time.
UCG in post-anaesthetic group	UCG	The fasting patients receive UCG in post-anaesthetic.

Primary Outcome Measures

Name	Time	Method
mitral regurgitant volume (RVol)	1 day during an examination	RVol measured by multiple imaging methods when patient is in the different
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 fraction (RF)	1 day during an examination	RF measured by multiple imaging methods when patient is in the different

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China