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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

Tracking Information
First Submitted Date September 3, 2019
First Posted Date September 9, 2019
Last Update Posted Date September 9, 2019
Actual Study Start Date November 26, 2016
Actual Primary Completion Date June 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 6, 2019)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 6, 2019)
  • 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.
  • 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Correlates of Left Ventricular Global Longitudinal Strain and Surgical Intervention on Myocardial Bridges
Official Title Not Provided
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients presenting a muscular myocardial bridge of the left anterior descending coronary artery causing chest discomfort/angina
Condition Myocardial Bridge of Coronary Artery
Intervention Procedure: Surgical unroofing of muscle-briged coronary artery
Medical therapy with beta-blockers or calcium-channels blockers
Other Name: Medical treatment
Study Groups/Cohorts
  • Surgical unroofing
    Refractory angina to medical treatment (beta-blockers or calcium channels blockers)
    Intervention: Procedure: Surgical unroofing of muscle-briged coronary artery
  • Medical treatment
    Responders to medical treatment for angina relief
    Intervention: Procedure: Surgical unroofing of muscle-briged coronary artery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 6, 2019)
10
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 3, 2020
Actual Primary Completion Date June 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Myocardial bridge of the anterior descending left coronary artery

Exclusion Criteria:

  • Poor echocardiographic imaging quality
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Francesco Bianco, MD francesco.bianco@unich.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04082546
Other Study ID Numbers CCPC001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Francesco Bianco, ITAB - Institute for Advanced Biomedical Technologies
Study Sponsor ITAB - Institute for Advanced Biomedical Technologies
Collaborators Azienda Ospedaliero, Universitaria Ospedali Riuniti
Investigators
Principal Investigator: Francesco Bianco, MD G. d'Annunzio University
PRS Account ITAB - Institute for Advanced Biomedical Technologies
Verification Date September 2019