Myocardial BridgeRIALTONCT05111418
Myocardial Bridge Evaluation Towards Personalised Medicine: the RIALTO Registry
An observational study of Myocardial Bridge, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 5 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Bridge
- How many people
- 444 participants
- Where
- 5 sitesItaly
- Study dates
- 17 Mar 2021to 17 Mar 2023
- How long will I take part?
- 2 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population with suspected coronary artery disease found to have a myocardial bridge with or without other epicardial lesions amenable to revascularization
Who may be able to join
- 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
Who cannot join
- Patients with life expectancy below 12 months
- Patients with severe valvular heart disease
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Arcispedale S. Anna, Azienda Ospedaliero - Universitaria di Ferrara
Ferrara, Italia, 44124
Policlinico S. Martino IRCCS, Università di Genova
Genova, Italia, 16132
Centro Cardiologico Monzino IRCCS
Milan, Italia, 20138
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italia, 00168
Policlinico Universitario Tor Vergata Fondazione PTV
Roma
About this study
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.
- Conditions
- Myocardial Bridge
- Keywords
- Myocardial Bridge, MACE, Ischemia, Beta-blockers, Coronary angiography, Personalised medicine
- Medical subject headings
- Myocardial Bridging, Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of MACE
Incidence of MACE defined as the composite of cardiac death, myocardial infarction, cardiac hospitalization and target vessel revascularization
Measured: 2 years follow up
Secondary outcomes (2)
Rate of patients with SAQ < 70
Measured: 2 years follow up
Rate of patients with "high risk features" on CT scan
High risk features
Measured: 2 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start17 Mar 2021
- Primary completion17 Mar 2022
- Study completion17 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial BridgeStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 444 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DAMARIO DOMENICO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111418
- Sponsor's protocol ID
- 3812
- Acronym
- RIALTO
- Status last verified
- Jul 2024
- First submitted
- 27 Oct 2021
- Last updated
- 10 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Bridge Evaluation Towards Personalised Medicine: the RIALTO Registry
- ClinicalTrials.gov ID
- NCT05111418
- Acronym / sponsor ID
- RIALTO / 3812
- Conditions
- Myocardial Bridge
- Keywords
- Myocardial Bridge, MACE, Ischemia, Beta-blockers, Coronary angiography, Personalised medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 8 Nov 2021 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population with suspected coronary artery disease found to have a myocardial bridge with or without other epicardial lesions amenable to revascularization
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with life expectancy below 12 months
- Patients with severe valvular heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of MACE
Time frame: 2 years follow up
Incidence of MACE defined as the composite of cardiac death, myocardial infarction, cardiac hospitalization and target vessel revascularization
2 secondary outcomes
Rate of patients with SAQ < 70
Time frame: 2 years follow up
Rate of patients with "high risk features" on CT scan
Time frame: 2 years follow up
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 10 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Myocardial Bridge
RecruitingPhase 4
The Bridging Antiplatelet Therapy With Cangrelor 2 Study
Coronary Arterial Disease (CAD)
RecruitingObservational study
Coronary Myocardial Bridge and Coronary Plaques on MDCT
Myocardial Bridging, Coronary Atherosclerosis
Not yet recruiting
BRIDGE Trial: Embedding Consumer-grade mHealth Technologies Into Cardiac Rehabilitation
Acute Myocardial Infarction (AMI), Percutaneous Coronary Intervention (PCI)
Recruiting
Myocardialbridge Bypass Graft Surgery Efficacy Verification
Myocardial Bridge of Coronary Artery, Myocardial Bridge
RecruitingPhase 2/3
Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries
Angina Pectoris, Microvascular Angina
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites 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, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 5 sites 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 3 inclusion and 2 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 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Incidence of MACE (time frame: 2 years follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2024.