Multimodality Imaging Assessment of the Severity of Mitral Regurgitation

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

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

Study Overview

• Status: Recruiting
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Diagnostic test: UCG; Other: fasting; Other: rehydration; Diagnostic test: CMR

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maohuan Lin, PhD; Phone Number: 13580575861; Email: maohuan_lin@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
      • Contact: Maohuan Lin, PhD; Phone Number: 13580575861; Email: maohuan_lin@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: UCG in pre-anaesthetic group; The fasting patients receive UCG in pre-anaesthetic.	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.; Other: fasting; At the beginning of the study, the patients need to fast when receive UCG.
Other: UCG in post-anaesthetic group; The fasting patients receive UCG in post-anaesthetic.	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.; Other: fasting; At the beginning of the study, the patients need to fast when receive UCG.
Other: UCG in post-rehydration group; The fasting patients in anaesthetised receive UCG in post-rehydration.	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.; Other: fasting; At the beginning of the study, the patients need to fast when receive UCG.; Other: rehydration; The fasting patients in anaesthetised receive saline rehydration to maintain central venous pressure of 6-8 cmH2O when undergoing UCG.
Other: cardiac magnetic resonance （CMR） group; The non-fasting patients receive CMR in another time.	Diagnostic test: CMR; CMR may be more accurate than UCG in assessing MR severity. In another time, the patients receive CMR.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Principal Investigator: Maohuan Lin, PhD, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: January 21, 2024
• First Submitted That Met QC Criteria: February 18, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: mitral regurgitation; cardiac magnetic resonance; ultrasonic cardiography
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: SYSKY-2022-407-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No