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

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ClinicalTrials.gov Identifier: NCT04082546
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Collaborator:
Azienda Ospedaliero, Universitaria Ospedali Riuniti
Information provided by (Responsible Party):
Francesco Bianco, 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).

Condition or disease Intervention/treatment
Myocardial Bridge of Coronary Artery Procedure: Surgical unroofing of muscle-briged coronary artery

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.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Actual Study Start Date : November 26, 2016
Actual Primary Completion Date : June 19, 2018
Estimated Study Completion Date : September 3, 2020

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 Name: 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 Name: Medical treatment




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting a muscular myocardial bridge of the left anterior descending coronary artery causing chest discomfort/angina
Criteria

Inclusion Criteria:

  • Myocardial bridge of the anterior descending left coronary artery

Exclusion Criteria:

  • Poor echocardiographic imaging quality

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082546


Contacts
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Contact: Francesco Bianco, MD francesco.bianco@unich.it

Locations
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Italy
Ospedali Riuniti Recruiting
Ancona, Italy
Contact: Francesco Bianco, MD       francesco.bianco@ospedaliriuniti.marche.it   
Contact: Valentina Bucciarelli, MD       valentina.bucciarelli@ospedaliriuniti.marche.it   
Sponsors and Collaborators
ITAB - Institute for Advanced Biomedical Technologies
Azienda Ospedaliero, Universitaria Ospedali Riuniti
Investigators
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Principal Investigator: Francesco Bianco, MD G. d'Annunzio University
Publications:
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Responsible Party: Francesco Bianco, Medical doctor, ITAB - Institute for Advanced Biomedical Technologies
ClinicalTrials.gov Identifier: NCT04082546    
Other Study ID Numbers: CCPC001
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francesco Bianco, ITAB - Institute for Advanced Biomedical Technologies:
Coronary abnormalities
Angina
Global longitudinal strain
Speckle-traking echocardiography
Myocardial ischemia
Additional relevant MeSH terms:
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Myocardial Bridging
Coronary Vessel Anomalies
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities