Clinical trial NCT06266858: Multimodality Imaging Assessment of the Severity of Mitral Regurgitation
Official title: A Single-Center, Open-Label Study to Assess the Severity of Mitral Regurgitation With Multimodality Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Keywords: mitral regurgitation
ultrasonic cardiography
cardiac magnetic resonance
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: effective regurgitant orifice area (EROA)
timeFrame: 1 day during an examination
measure: mitral regurgitant volume (RVol)
timeFrame: 1 day during an examination
measure: mitral regurgitant fraction (RF)
timeFrame: 1 day during an examination
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Maohuan Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References: