Multimodality Imaging Assessment of the Severity of Mitral Regurgitation

Last updated: February 18, 2024
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mitral Valve Regurgitation

Congestive Heart Failure

Treatment

rehydration

CMR

UCG

Clinical Study ID

NCT06266858
SYSKY-2022-407-02
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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
  1. The patient has signed an informed consent form.

Exclusion

Exclusion Criteria:

  1. unstable angina, acute myocardial infarction and surgical history of coronary arterybypass grafting (CABG) and percutaneous coronary intervention (PCI) within 3 monthsbefore recruit
  2. acute heart failure or acute worsening of chronic heart failure requiring vasoactivedrug therapy
  3. severe infections, septicaemia
  4. severe hepatic insufficiency ( Child-Pugh class C)
  5. severe renal insufficiency ( chronic kidney disease (CKD) stage 5: estimatedglomerular 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 ordeep vein thrombosis, congenital or acquired haemorrhagic disease such as haemophilia,anaphylactic purpura and acute leukaemia, severe abnormalities in haematologicalparameters such as platelet count <20*10^9/l and international normalized ratio (INR) >3
  8. contraindication for Trans-Esophageal Echocardiography (TEE) such as oesophagealconstriction, oesophageal tumour, oesophageal fistula, oesophageal varices, cervicalvertebral 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 theresearcher.

Study Design

Total Participants: 150
Treatment Group(s): 4
Primary Treatment: rehydration
Phase:
Study Start date:
December 01, 2022
Estimated Completion Date:
June 30, 2024

Study 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.

Connect with a study center

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

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

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