Multimodality Imaging Assessment of the Severity of Mitral Regurgitation

NCT06266858 | Recruiting

• 1 other identifier: SYSKY-2022-407-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mitral Regurgitation

Keywords

mitral regurgitation; ultrasonic cardiography; cardiac magnetic resonance

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

UCG in pre-anaesthetic group

OTHER

The fasting patients receive UCG in pre-anaesthetic.

Diagnostic Test: UCG; Other: fasting

UCG in post-anaesthetic group

OTHER

The fasting patients receive UCG in post-anaesthetic.

Diagnostic Test: UCG; Other: fasting

UCG in post-rehydration group

OTHER

The fasting patients in anaesthetised receive UCG in post-rehydration.

Other: rehydration; Diagnostic Test: UCG; Other: fasting

cardiac magnetic resonance （CMR） group

OTHER

The non-fasting patients receive CMR in another time.

Diagnostic Test: CMR

Interventions

rehydration OTHER

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

UCG in post-rehydration group

UCG DIAGNOSTIC_TEST

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.

UCG in post-anaesthetic group; UCG in post-rehydration group; UCG in pre-anaesthetic group

CMR DIAGNOSTIC_TEST

CMR may be more accurate than UCG in assessing MR severity. In another time, the patients receive CMR.

cardiac magnetic resonance （CMR） group

fasting OTHER

At the beginning of the study, the patients need to fast when receive UCG.

UCG in post-anaesthetic group; UCG in post-rehydration group; UCG in pre-anaesthetic group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years old
• all-caused moderate or severe MR assessed by Trans-Thoracic Echocardiography (TTE) : 1) EROA ≥0.3cm\^2; 2) RVol ≥45ml
• The patient has signed an informed consent form.

You may not qualify if:

• unstable angina, acute myocardial infarction and surgical history of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) within 3 months before recruit
• acute heart failure or acute worsening of chronic heart failure requiring vasoactive drug therapy
• severe infections, septicaemia
• severe hepatic insufficiency ( Child-Pugh class C)
• severe renal insufficiency ( chronic kidney disease (CKD) stage 5: estimated glomerular filtration rate (eGFR) \<15ml/min or dialysis)
• hypotensive state, shock ( systolic blood pressure \<90mmHg or mean arterial pressure \<70mmHg with tissue hypoperfusion and urine output \<30ml/h)
• 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
• contraindication for Trans-Esophageal Echocardiography (TEE) such as oesophageal constriction, oesophageal tumour, oesophageal fistula, oesophageal varices, cervical vertebral instability
• contraindication for CMR such as metal foreign matter in the body, claustrophobia
• contraindication for intravenous anaesthesia such as allergy to anaesthetics
• pregnancy or breastfeeding
• The patient does not sign an informed consent form.
• Due to other reasons the patient is not suitable for enrollment assessed by the researcher.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Interventions

Fluid Therapy; Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Maohuan Lin, PhD

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maohuan Lin, PhD

CONTACT

13580575861; maohuan_lin@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: February 20, 2024
• Study Start: December 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

CN (1)