NCT04082546

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 26, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2020

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

1.6 years

First QC Date

September 3, 2019

Last Update Submit

December 28, 2020

Conditions

Myocardial Bridge of Coronary Artery

Keywords

Coronary abnormalitiesAnginaGlobal longitudinal strainSpeckle-traking echocardiographyMyocardial ischemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Angina relief after surgical treatment

    1-month

  • Improvement in quality of life

    1-month

Study Arms (2)

Surgical unroofing

Refractory angina to medical treatment (beta-blockers or calcium channels blockers)

Procedure: Surgical unroofing of muscle-briged coronary artery

Medical treatment

Responders to medical treatment for angina relief

Procedure: Surgical unroofing of muscle-briged coronary artery

Interventions

Surgical unroofing of muscle-briged coronary arteryPROCEDURE

Medical therapy with beta-blockers or calcium-channels blockers

Also known as: Medical treatment
Medical treatmentSurgical unroofing

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting a muscular myocardial bridge of the left anterior descending coronary artery causing chest discomfort/angina

You may qualify if:

  • Myocardial bridge of the anterior descending left coronary artery

You may not qualify if:

  • Poor echocardiographic imaging quality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedali Riuniti

Ancona, Italy

Location

Related Publications (5)

  • Alegria JR, Herrmann J, Holmes DR Jr, Lerman A, Rihal CS. Myocardial bridging. Eur Heart J. 2005 Jun;26(12):1159-68. doi: 10.1093/eurheartj/ehi203. Epub 2005 Mar 11.

    PMID: 15764618BACKGROUND

  • 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.

    PMID: 24583304BACKGROUND

  • 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. No abstract available.

    PMID: 27923515BACKGROUND

  • 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.

    PMID: 31087389BACKGROUND

  • 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.

    PMID: 22913217BACKGROUND

MeSH Terms

Conditions

Angina PectorisMyocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Francesco Bianco, MD

    G. d'Annunzio University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

September 3, 2019

First Posted

September 9, 2019

Study Start

November 26, 2016

Primary Completion

June 19, 2018

Study Completion

September 3, 2020

Last Updated

December 29, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)