Multimodality Imaging Assessment of the Severity of Mitral Regurgitation

Mitral Regurgitation Clinical Trial

Official title:

A Single-Center, Open-Label Study to Assess the Severity of Mitral Regurgitation With Multimodality Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06266858
• Other study ID #: SYSKY-2022-407-02
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Maohuan Lin, PhD
• Phone: 13580575861
• Email: maohuan_lin[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate to assess the severity of mitral regurgitation by multimodality imaging.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Other:
• rehydration
The fasting patients in anaesthetised receive saline rehydration to maintain central venous pressure of 6-8 cmH2O when undergoing UCG.

Diagnostic Test:
• 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.

Other:
• fasting
At the beginning of the study, the patients need to fast when receive UCG.

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effective regurgitant orifice area (EROA)	EROA measured by multiple imaging methods when patient is in the different situation.	1 day during an examination
Primary	mitral regurgitant volume (RVol)	RVol measured by multiple imaging methods when patient is in the different	1 day during an examination
Primary	mitral regurgitant fraction (RF)	RF measured by multiple imaging methods when patient is in the different	1 day during an examination