Myocardial Bridge of Coronary ArteryNCT04082546
Correlates of Left Ventricular Global Longitudinal Strain and Surgical Intervention on Myocardial Bridges
An observational study of Myocardial Bridge of Coronary Artery, run by ITAB - Institute for Advanced Biomedical Technologies at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Bridge of Coronary Artery
- What is being tested?
- Surgical unroofing of muscle-briged coronary artery
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 26 Nov 2016to 3 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients presenting a muscular myocardial bridge of the left anterior descending coronary artery causing chest discomfort/angina
Who may be able to join
- Myocardial bridge of the anterior descending left coronary artery
Who cannot join
- Poor echocardiographic imaging quality
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Myocardial Bridge of Coronary Artery
- Being tested
- Surgical unroofing of muscle-briged coronary artery
- Keywords
- Coronary abnormalities, Angina, Global longitudinal strain, Speckle-traking echocardiography, Myocardial ischemia
- Medical subject headings
- Angina Pectoris, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical unroofing of muscle-briged coronary arteryProcedure or surgery
Also called Medical treatment
Medical therapy with beta-blockers or calcium-channels blockers
| Study group | Role | What they receive |
|---|---|---|
| Surgical unroofing | Refractory angina to medical treatment (beta-blockers or calcium channels blockers) Receives: Procedure: Surgical unroofing of muscle-briged coronary artery | |
| Medical treatment | Responders to medical treatment for angina relief Receives: Procedure: Surgical unroofing of muscle-briged coronary artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of myocardial function and contractility
The increment of global longitudinal strain analysis, from pre treatment values, as assessed by speckle-traking echocardiography
Measured: 1 to 6 month after the procedure/treatment optimizzation
Secondary outcomes (2)
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.
Measured: 1-month
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).
Measured: 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start26 Nov 2016
- Primary completion19 Jun 2018
- Study completion3 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Myocardial Bridge of Coronary ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- ITAB - Institute for Advanced Biomedical Technologies
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero, Universitaria Ospedali Riuniti
- Responsible party
- Principal investigator, Francesco Bianco, ITAB - Institute for Advanced Biomedical Technologies
- Investigators
- Francesco Bianco, MD, Principal investigator, G. d'Annunzio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082546
- Sponsor's protocol ID
- CCPC001
- Status last verified
- Dec 2020
- First submitted
- 3 Sep 2019
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15764618Corban 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.
PubMed 24583304Cerit 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.
PubMed 27923515Zhang 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.
PubMed 31087389Alessandri 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.
PubMed 22913217
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlates of Left Ventricular Global Longitudinal Strain and Surgical Intervention on Myocardial Bridges
- ClinicalTrials.gov ID
- NCT04082546
- Acronym / sponsor ID
- CCPC001
- Conditions
- Myocardial Bridge of Coronary Artery
- Keywords
- Coronary abnormalities, Angina, Global longitudinal strain, Speckle-traking echocardiography, Myocardial ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- ITAB - Institute for Advanced Biomedical TechnologiesUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero, Universitaria Ospedali Riuniti
- Study start
- 26 Nov 2016 (actual)
- Primary completion
- 19 Jun 2018 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical unroofing | – | Procedure: Surgical unroofing of muscle-briged coronary arteryRefractory angina to medical treatment (beta-blockers or calcium channels blockers) |
| Medical treatment | – | Procedure: Surgical unroofing of muscle-briged coronary arteryResponders to medical treatment for angina relief |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting a muscular myocardial bridge of the left anterior descending coronary artery causing chest discomfort/angina
Key inclusion criteria (1 listed)
- Myocardial bridge of the anterior descending left coronary artery
Key exclusion criteria (1 listed)
- Poor echocardiographic imaging quality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical unroofing of muscle-briged coronary arteryAlso: Medical treatmentMedical therapy with beta-blockers or calcium-channels blockers | Procedure or surgery | Medical treatment, Surgical unroofing |
Primary outcome
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
2 secondary outcomes
Angina relief after surgical treatment
Time frame: 1-month
Improvement in quality of life
Time frame: 1-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Background: PubMed 15764618Alegria 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.
- Background: PubMed 24583304Corban 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.
- Background: PubMed 27923515Cerit 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.
- Background: PubMed 31087389Zhang 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.
- Background: PubMed 22913217Alessandri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Bianco, MD principal investigator
G. d'Annunzio University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Bridge of Coronary Artery, run by ITAB - Institute for Advanced Biomedical Technologies at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of myocardial function and contractility (time frame: 1 to 6 month after the procedure/treatment optimizzation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04082546, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.