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OpenTrials
Completed

NCT Number: NCT04082546

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

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).

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Key information

Conditions

Myocardial Bridge of Coronary Artery Angina Pectoris Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedali Riuniti

Ancona, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Myocardial bridge of the anterior descending left coronary artery

Exclusion criteria

  • Poor echocardiographic imaging quality

Treatment and study plan

Surgical unroofing of muscle-briged coronary artery

Procedure

Medical therapy with beta-blockers or calcium-channels blockers

Other names: Medical treatment

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

ITAB - Institute for Advanced Biomedical Technologies

Other

Collaborators

  • Azienda Ospedaliero, Universitaria Ospedali Riuniti

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Sep 9, 2019
Registry last updated
Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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