Ignite Creation Date:
2024-05-06 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05111418
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2021-10-27
Brief Title:
Myocardial Bridge Evaluation Towards Personalised Medicine the RIALTO Registry
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Myocardial Bridge Evaluation Towards Personalised Medicine the RIALTO Registry
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIALTO
Brief 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 yo 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
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 yo 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None