Assessing the severity of mitral regurgitation using advanced imaging techniques
A Single-Center, Open-Label Study to Assess the Severity of Mitral Regurgitation With Multimodality Imaging
This study is testing how different conditions like fasting and hydration affect the way we measure the severity of mitral regurgitation in patients using advanced imaging techniques.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06266858 on ClinicalTrials.gov |
What this trial studies
This study investigates the severity of mitral regurgitation (MR) through multimodality imaging, specifically focusing on ultrasonic cardiography (UCG) and cardiac magnetic resonance (CMR). It is a single-center, open-label study where patients will undergo assessments in different states: fasting, anesthesia, and after intravenous rehydration. The goal is to clarify how these conditions affect MR severity assessment and to establish more accurate and reproducible imaging parameters. Ultimately, the findings aim to enhance clinical decision-making regarding treatment and timing for patients with MR.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with moderate to severe mitral regurgitation as assessed by echocardiography.
Not a fit: Patients with unstable angina, recent myocardial infarction, or severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate assessments of mitral regurgitation severity, improving treatment outcomes for patients.
How similar studies have performed: While multimodality imaging is a recognized approach, this specific investigation into the effects of fasting and anesthesia on MR assessment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen Memorial Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Maohuan Lin, PhD — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study coordinator: Maohuan Lin, PhD
- Email: maohuan_lin@163.com
- Phone: 13580575861
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.