Correlates of Left Ventricular Global Longitudinal Strain and Surgical Intervention on Myocardial Bridges

December 28, 2020 updated by: Francesco Bianco, ITAB - Institute for Advanced Biomedical Technologies
To examine the changes in left ventricular (LV) global longitudinal strain (GLS), using two-dimensional speckle tracking analysis, after left anterior descending (LAD) unroofing, in myocardial bridges (MBs) refractory to optimal medical therapy (OMT).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The present study is enrolling all the MBs-patients who underwent angina surgical relief or medical treatment at the "Ospedali Riuniti" of Ancona, Italy, and the "University Hospital" of Chieti, Italy. All the participants will be examined utilizing echocardiography before and after the treatment. The two-dimensional speckle-tracking analysis will be performed with an off-line dedicated software from the apical 4-chambers-view. All the unroofing procedures will be performed under cardiopulmonary bypass.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

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

Study Locations

  • Italy
      • Ancona, Italy
        • Ospedali Riuniti

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting a muscular myocardial bridge of the left anterior descending coronary artery causing chest discomfort/angina

Description

Inclusion Criteria:

  • Myocardial bridge of the anterior descending left coronary artery

Exclusion Criteria:

  • Poor echocardiographic imaging quality

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical unroofing
Refractory angina to medical treatment (beta-blockers or calcium channels blockers)
Procedure: Surgical unroofing of muscle-briged coronary artery
Medical therapy with beta-blockers or calcium-channels blockers
Other Names:
  • Medical treatment
Medical treatment
Responders to medical treatment for angina relief
Procedure: Surgical unroofing of muscle-briged coronary artery
Medical therapy with beta-blockers or calcium-channels blockers
Other Names:
  • Medical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of myocardial function and contractility
Time Frame: 1 to 6 month after the procedure/treatment optimizzation
The increment of global longitudinal strain analysis, from pre treatment values, as assessed by speckle-traking echocardiography
1 to 6 month after the procedure/treatment optimizzation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angina relief after surgical treatment
Time Frame: 1-month
Defined as the reduction of CCS-Angina Scale, assessed by physicians, from grade I (ordinary physical activity does not cause angina, such as walking and climbing stairs) to grade IV (inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest). The scale comprises 4 degrees in increasing order of angina severity.
1-month
Improvement in quality of life
Time Frame: 1-month
Defined as the score increment, from 0 to 100 of the SAQ-7 questionnaire. The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptomstheir satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. The questionnaire provides 7 different items with 6 different multiple choices. Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
1-month

Collaborators and Investigators

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

Sponsor

ITAB - Institute for Advanced Biomedical Technologies

Collaborators

Azienda Ospedaliero, Universitaria Ospedali Riuniti

Investigators

  • Principal Investigator: Francesco Bianco, MD, G. d'Annunzio 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 (Actual)

November 26, 2016

Primary Completion (Actual)

June 19, 2018

Study Completion (Actual)

September 3, 2020

Study Registration Dates

First Submitted

September 3, 2019

First Submitted That Met QC Criteria

September 6, 2019

First Posted (Actual)

September 9, 2019

Study Record Updates

Last Update Posted (Actual)

December 29, 2020

Last Update Submitted That Met QC Criteria

December 28, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCPC001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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