Ventricular-arterial Coupling of the Heart Among Patients With Mitral Stenosis Undergoing Percutaneous Trans-luminal Mitral Commissurotomy. Cardiac Magnetic Resonance Study

November 20, 2023 updated by: Mary Zakher Bakhiet, Assiut University

Although the incidence of rheumatic fever and its complications has declined in developed countries, the disease remains a major health problem in many developing countries. It is estimated that up to 30 million school-age children and young adults worldwide suffer from chronic rheumatic heart disease, and almost a third of them suffer from mitral valve stenosis (MS).

Various treatments are currently available to patients, including medical, surgical, and percutaneous mitral commissurotomy (PTMC), depending on the severity of symptoms, the type and severity of mitral stenosis, and the morphology of the mitral valve.

Successfully performed PTMC increases the optimal mitral valve area and is unlikely to result in significant mitral valve regurgitation. PTMC candidates are selected according to the latest European society of cardiology (ESC) guidelines for the treatment of mitral stenosis based on echocardiographic examination of the mitral valve and its dimensions. The Wilkins score, determined using ultrasound, is an important tool for patient selection.

CMR provides tomographic assessment of the heart with high spatial resolution and enables accurate assessment of ventricular volume, identification of segmental kinetic abnormalities, and detection of tissue changes such as fibrosis, edema, or fatty substitution.

Patients with severe mitral stenosis who underwent percutaneous mitral commissurotomy (PTMC) showed significant changes in right ventricular (RV) function. One study assessed the pre and post changes in RV function after PTMC and found significant improvements in RV parameters such as RV systolic pressure, RV outlet FS, RV TEi index, RV wall thickness, and pulmonary artery systolic pressure.

Successful balloon mitral valvuloplasty (BMV) in patients with rheumatic mitral stenosis (MS) is associated with improvement in left ventricular (LV) function and remodeling. A study using cardiac magnetic resonance imaging (CMR) found that BMV led to an increase in LV peak systolic global longitudinal strain (GLS) and global circumferential strain (GCS) at 6 months, with further improvement at 1 year.

Ventriculo-arterial coupling (VAC) plays an important role in the physiology of cardiac and aortic mechanics as well as in the pathophysiology of heart disease. VAC assessment has independent diagnostic and prognostic value and can be used to improve risk stratification and monitor therapeutic interventions. Traditionally, VAC is assessed by noninvasive measurement of the end-systolic elasticity ratio of arteries (Ea) and ventricles (Ees). Therefore, measuring any component of this ratio or new, more sensitive myocardial markers (e.g.B. global longitudinal strain) and arterial function (e.g. pulse wave velocity) can better characterize the VAC. In valvular heart disease, systemic arterial compliance and valve-arterial impedance have established diagnostic and prognostic value and can monitor the effects of valve replacement on vascular and cardiac function. Treatment to improve VAC by improving one of its components may delay the onset of heart failure and potentially improve the prognosis of heart failure.

According to Ozdogru I et al, A study of patients with severe mitral stenosis undergoing percutaneous balloon valvuloplasty and healthy subjects, demonstrated that mitral stenosis induced an increase in arterial stiffness that was improved after percutaneous balloon valvuloplasty.

Diastolic dysfunction has emerged as an important predictor of adverse outcomes in multiple forms of congenital heart disease.

A recently derived CMR prognostic tool, the left atrioventricular coupling index (LACI), has been evaluated as part of the Multi-Ethnic Study of Atherosclerosis (MESA). LACI is defined as the ratio between LA end-diastolic volume and LV end diastolic volume. It was created to determine whether the close physiological relationship between the LA and LV could serve as a primary prevention tool in the early detection of cardiovascular disease. LACI has been shown to serve as a strong predictor for the incidence of heart failure, atrial fibrillation, cardiovascular disease, and coronary heart disease death in healthy adult populations. A novel right atrioventricular coupling index can potentially help with risk stratification, novel parameter, termed the Right Atrioventricular Coupling Index (RACI), and was defined as the ratio of RA end-diastolic volume to right ventricle (RV) end-diastolic volume.

According to our knowledge there was no specific study was done using cardiac magnetic resonance imaging (CMR) for assessment of Ventricular-arterial coupling pre and post PTMC

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The study will include patients with mitral stenosis undergoing PTMC

Description

Inclusion Criteria:

  • Subjects with severe MS eligible for PTMC according to the recent ESC Guidelines for the management of valvular heart disease 2021

Exclusion Criteria:

  1. Patient with contraindication to CMR (e.g. due to pacemakers, implantable cardioverter defibrillators, claustrophobia, .. etc)
  2. Patients with associated coronary artery disease.
  3. Patients with other significant valvular heart disease including organic tricuspid valve disease
  4. Patients with any type of cardiomyopathy
  5. Patients with renal impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patient with Mitral stenosis undergoing Percutaneous Mitral trans-luminal commissurotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of atrio-ventricular coupling and ventricular arterial coupling assessed via cardiac magnetic resonance pre and post percutaneous trans-luminal mitral commissurotomy at the pre-specified time points
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cardiac magnetic resonance

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

because it not decided till now

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mitral Valve Stenosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe