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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05111418
Other study ID # 3812
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 17, 2021
Est. completion date March 17, 2023

Study information

Verified date February 2024
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Myocardial bridge (MB) is a congenital anomaly of epicardial circulation characterized by an intramural course of a coronary segment. This anatomical arrangement causes the artery to be squeezed during systole potentially causing flow impairment and ischemia. For this study, MB is defined as the presence of systolic compression in an epicardial vessel causing at least 50% of caliber reduction from diastole. MB can be disabling as it worsens the quality of life. Early detection of this congenital condition is crucial, and an invasive functional assessment of the ischemic burden should be considered to evaluate the need for medical or surgical therapy. This is an observational study, involving four Italian centres. Study Objectives are: To assess the risk of future cardiovascular complications in patients with MB referred for coronary angiography and the role of beta-blocker therapy; To describe the clinical and anatomical characteristics of patients presenting with MB; To determine the impact of cardiovascular medications on symptoms in patients with MB; To describe the anatomical and clinical features associated with the invasive evidence of ischemia in patients with MB; To assess the relation between invasively documented ischemia and clinical manifestations in patients with the MB. Inclusion Criteria: patients referred to undergo ICA (for both elective or urgent indications) for suspected coronary artery disease found to have an MB with or without other epicardial lesions amenable to revascularization; Age above 18 y.o.; Ability to provide Informed Consent. Exclusion Criteria are Patients with life expectancy below 12 months and Patients with severe valvular heart disease. The primary endpoint is the incidence of MACE defined as the composite of cardiac death, myocardial infarction, cardiac hospitalization, and target vessel revascularization. The secondary endpoint is evaluating the Rate of patients with SAQ < 70 and the Rate of patients with "high-risk features" on CT scan.


Recruitment information / eligibility

Status Completed
Enrollment 444
Est. completion date March 17, 2023
Est. primary completion date March 17, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients referred to undergo ICA (for both elective or urgent indications) for suspected coronary artery disease found to have a myocardial bridge with or without other epicardial lesions amenable to revascularization - Age above 18 y.o. - Ability to provide Informed Consent Exclusion Criteria: - Patients with life expectancy below 12 months - Patients with severe valvular heart disease

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Arcispedale S. Anna, Azienda Ospedaliero - Universitaria di Ferrara Ferrara Italia
Italy Policlinico S. Martino IRCCS, Università di Genova Genova Italia
Italy Centro Cardiologico Monzino IRCCS Milano Italia
Italy Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Italia

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of MACE Incidence of MACE defined as the composite of cardiac death, myocardial infarction, cardiac hospitalization and target vessel revascularization 12 months
Secondary Rate of patients with SAQ < 70 12 months
Secondary Rate of patients with "high risk features" on CT scan High risk features 12 months
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