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

Myocardial Bridge of Coronary Artery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04082546
• Other study ID #: CCPC001
• Status: Completed
• Start date: November 26, 2016
• Est. completion date: September 3, 2020

Study information

• Verified date: December 2020
• Source: ITAB - Institute for Advanced Biomedical Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 3, 2020
• Est. primary completion date: June 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Myocardial bridge of the anterior descending left coronary artery

Exclusion Criteria:

• Poor echocardiographic imaging quality

Related Conditions & MeSH terms

• Myocardial Bridge of Coronary Artery
• Myocardial Bridging

Intervention

Procedure:
• Surgical unroofing of muscle-briged coronary artery
Medical therapy with beta-blockers or calcium-channels blockers

Locations

Country	Name	City	State
Italy	Ospedali Riuniti	Ancona

Sponsors (2)

Lead Sponsor	Collaborator
ITAB - Institute for Advanced Biomedical Technologies	Azienda Ospedaliero, Universitaria Ospedali Riuniti

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Alegria JR, Herrmann J, Holmes DR Jr, Lerman A, Rihal CS. Myocardial bridging. Eur Heart J. 2005 Jun;26(12):1159-68. Epub 2005 Mar 11. Review. — View Citation

Alessandri N, Dei Giudici A, De Angelis S, Urciuoli F, Garante MC, Di Matteo A. Efficacy of calcium channel blockers in the treatment of the myocardial bridging: a pilot study. Eur Rev Med Pharmacol Sci. 2012 Jun;16(6):829-34. — View Citation

Cerit L, Duygu H. Myocardial bridging and sudden death. Int J Cardiol. 2017 Feb 15;229:11. doi: 10.1016/j.ijcard.2016.11.308. Epub 2016 Dec 1. — View Citation

Corban MT, Hung OY, Eshtehardi P, Rasoul-Arzrumly E, McDaniel M, Mekonnen G, Timmins LH, Lutz J, Guyton RA, Samady H. Myocardial bridging: contemporary understanding of pathophysiology with implications for diagnostic and therapeutic strategies. J Am Coll Cardiol. 2014 Jun 10;63(22):2346-2355. doi: 10.1016/j.jacc.2014.01.049. Epub 2014 Feb 26. Review. — View Citation

Zhang M, Yang J, Ma C, Liu M. Longitudinal strain measured by two-dimensional speckle tracking echocardiography to evaluate left ventricular function in patients with myocardial bridging of the left anterior descending coronary artery. Echocardiography. 2019 Jun;36(6):1066-1073. doi: 10.1111/echo.14357. Epub 2019 May 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of myocardial function and contractility	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	Angina relief after surgical treatment	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
Secondary	Improvement in quality of life	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