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

Completed

• Conditions: Myocardial Bridge of Coronary Artery

• Registration Number: NCT04082546
• Lead Sponsor: ITAB - Institute for Advanced Biomedical Technologies

Brief Summary

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).

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 Timeline

• Study Start: 2016-11-26
• Primary Completion: 2018-06-19
• Study First Submitted: 2019-09-03
• Study First Submitted QC: 2019-09-06
• Study First Posted: 2019-09-09
• Study Completion: 2020-09-03
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-28
• Last Update Posted: 2020-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Myocardial bridge of the anterior descending left coronary artery

Exclusion Criteria

• Poor echocardiographic imaging quality

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of myocardial function and contractility	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

Secondary Outcome Measures

Name	Time	Method
Angina relief after surgical treatment	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.
Improvement in quality of life	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).

Trial Locations

Locations (1)

Ospedali Riuniti; 🇮🇹 Ancona, Italy